Ethics and Policy

Reproductive ethics, informed consent, and the professional standards and policy that shape reproductive care.

145 articles

Advocacy and Public Understanding · Public Awareness

Public Awareness, Perceptions, and Preferences in Fertility Treatment: Secondary Analysis of Two Public Surveys

Parnell TA et al., 2026 Journal of Restorative Reproductive Medicine

This study examined public attitudes toward restorative reproductive medicine (RRM) and in vitro fertilization (IVF) using secondary analysis and comparative reporting of two independent surveys conducted in the United States. It also explored preferences among individuals with fertility issues and the general population’s views on treatment options. A secondary analysis was conducted using data from two nationally representative online surveys, designed and administered by organizations independent of the researchers, whose samples demographically reflected the U.S. adult population. The surveys—conducted by J.L. Partners (N=1002) and McLaughlin & Associates (N=1000)—assessed familiarity, acceptance, and attitudes toward IVF and RRM. The J.L. Partners survey focused on IVF, including medical risks, creation and use of embryos, preimplantation genetic testing, arguments for government oversight of IVF, and overall attitudes toward IVF. The McLaughlin survey focused on comparative descriptions of IVF and RRM. Pearson’s Chi-Square tests of independence were used to assess differences in response distributions across demographic subgroups and between survey items of interest. Findings: Overall, there was strong consistency of responses to items that were similar in the two surveys. Approximately 80% supported IVF initially, although both surveys found respondents to have limited knowledge about IVF procedures. In contrast, 33% supported RRM initially, with 43% having never heard of RRM. After learning more about the characteristics of RRM and IVF approaches, as presented within the surveys, preference shifted toward approaches consistent with RRM (e.g., 69% preference for an approach for natural fertilization in a woman’s body vs. 17% for fertilization in a lab). Respondents prioritized baby health (74%) over cost (13%) and time to conceive (6%). Many IVF patients were concerned about undiagnosed health issues and being rushed into IVF. Overall, 70% wanted treatments that addressed underlying causes; nearly half were unaware of any medical risks of IVF. Stated support for IVF declined by 10% overall after presentation of medical risks, questions about the creation and use of embryos and genetic testing, and arguments to support government oversight of IVF. Both surveys showed strong support for patient access to full information about treatments and treatment processes. While IVF is widely accepted, these national survey data suggest preferences for fertility treatments that prioritize diagnosis and restoration of natural reproductive health, which is the focus of restorative reproductive medicine. Comprehensive assessment, restoration of healthy function, transparency regarding treatment processes, and sensitivity to ethical concerns in patient care reflect important public values. Greater awareness and public education, improved consent, more research, and ongoing surveys are needed to inform public health strategies and meet patient needs in fertility care.

Policy and Regulation · Professional Standards

Information and misinformation on assisted human reproduction techniques in Europe: a normative analysis of the information provided on the websites of medically assisted reproduction clinics

Albert M et al., 2026 BMC medical ethics

As part of the European Be better informed about Fertility project (B2-InF), we carried out a normative analysis of the information provided online by assisted reproduction clinics to the European public. This analysis aimed to determine the degree to which this information complies with regulations of medically assisted reproduction (MAR) and commercial information, and the main ethical implications related to the duty of information. Information was gathered from the websites of 33 clinics across 8 European countries (Albania, Belgium, Spain, Italy, Kosovo, Northern Macedonia, Slovenia, Switzerland). Nearly 2000 pages of information were reviewed and checked for compliance with relevant frameworks of national and international law. The assessment revealed significant inconsistencies in how clinics present information online, with particular concerns regarding transparency about success rates, associated risks, add-on techniques and the legal and ethical issues that may arise during the use of these techniques. The results of our analysis indicate an urgent need for enhanced regulatory oversight and standardized information requirements for assisted reproduction clinics across Europe. These findings suggest the necessity for harmonized legal frameworks that mandate comprehensive disclosure standards and establish effective enforcement mechanisms to ensure transparent and accurate information provision to potential patients.

Policy and Regulation · Professional Standards

Overview of HFEA Public Consultation on Choose a Fertility Clinic 2025

Human Fertilisation and Embryology Authority, 2025

# Overview of HFEA public consultation on Choose a Fertility Clinic 2025 Consultation held August-September 2025 on clinic’s main profile statistics on the Choose a Fertility Clinic webpage Published: December 2025 ## Table of contents - [Introduction](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#introduction) - [Main points](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#main-points) - Summary of findings from the consultation - [Section 1: Overview of response groups](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#section-1) - [Section 2: Main profile page statistic: which was the preferred rate?](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#section-2) - [Section 3: Presenting a combined rate](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#section-3) - [Section 4: Inclusion of different treatment types](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#section-4) - [Section 5: Additional considerations for the HFEA](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#section-5) - [About the HFEA](https://www.hfea.gov.uk/about-us/publications/research-and-data/overview-of-hfea-public-consultation-on-choose-a-fertility-clinic-2025/#about-the-hfea) ## The HFEA has a statutory duty to provide information to the public about fertility treatment. Using the data collected from licensed fertility clinics, we publish verified information on th...

Reproductive Ethics · Embryo Status

Is termination of a desired pregnancy due to possible fetal abnormalities a case of moral injury? A preliminary report

Sartel-Raviv S et al., 2025 Death studies

Termination of pregnancy (TOP) due to possible fetal abnormalities is known to be associated with various mental health problems. This study examines associations between potentially morally injurious events (PMIEs), moral injury outcomes (MI), posttraumatic stress disorder (PTSD), and prolonged grief (PG) among treatment-seeking women following late pregnancy loss. A volunteer sample of (n = 132) Israeli women who attended a reproductive psychiatry clinic following TOP (n = 99) or pregnancy loss due to intrauterine fetal demise (IUFD; n = 33), responded to self-report questionnaires in a cross-sectional, comparative study. Results show that among participants in the TOP group, PMIEs-self predicted MI outcomes of shame, and PMIEs-betrayal predicted MI outcomes of trust violation. Importantly, following exposure to PMIE-self, MI outcomes of trust violation significantly predicted both PTSD and PG symptoms. This study emphasized that TOP due to possible fetal abnormalities, may constitute a morally injurious experience, highlighting the need for clinical interventions addressing MI.

Policy and Regulation · Professional Standards

HFEA Code of Practice (9th edition, version 9.4)

Human Fertilisation and Embryology Authority, 2024

The HFEA Code of Practice gives guidance to clinics about the proper conduct of activities licensed under the Human Fertilisation and Embryology Act 1990 (as amended). The 9th edition (effective 26 October 2023) was further amended for version 9.4 (effective 1 October 2024). The Code consolidates statutory regulations, license conditions, and HFEA guidance covering: clinic governance, staff training and qualifications, identity checks and consent, gamete and embryo storage, donor recruitment and screening, donation arrangements, treatment licensing, pre-implantation genetic testing, multiple births policy, surrogacy, witnessing procedures, traceability, adverse incidents reporting, complaints, research licensing, and information disclosure. Compliance with the Code is a statutory requirement for all UK clinics licensed by the HFEA. Version 9.4 includes updated guidance on donor compensation (effective October 2024) and known donation for people with undetectable HIV (effective November 2024).

Reproductive Ethics · Embryo Status

Planned oocyte cryopreservation to preserve future reproductive potential: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2024 Fertility and sterility

Planned oocyte cryopreservation is an ethically permissible procedure that may help individuals avoid future infertility. Because planned oocyte cryopreservation is new and evolving, it is essential that those considering using it be informed about the uncertainties regarding its efficacy and long-term effects. This replaces the document of the same name, last published in 2017.

Advocacy and Public Understanding · Public Awareness

Exploring the Complex Landscape of Delayed Childbearing: Factors, History, and Long-Term Implications

Zabak S et al., 2023 Cureus

This review article delves into the intricate landscape of delayed childbearing, shedding light on the factors influencing individuals' decisions to postpone parenthood. In a world undergoing rapid social, economic, and technological transformations, the concept of when and why to become a parent has evolved significantly. We explore historical trends, societal norms, psychological dynamics, policy implications, and prospects surrounding delayed childbearing. This review underscores the diverse influences shaping this trend, from economic considerations and changing cultural perspectives to advancements in reproductive technologies and the complexities of work-life balance. By examining the emotional dimensions and long-term consequences, we comprehensively understand the implications for individuals, families, and societies. As we conclude, we emphasize the importance of addressing challenges and embracing opportunities to create a supportive environment for those navigating the complex decisions tied to delayed childbearing.

Reproductive Ethics · Conscience Protections

Women's health, hormonal balance, and personal autonomy

Segarra I et al., 2023 Front Med (Lausanne) Open Access

Hormone-based contraception disrupts hormonal balance, creating artificial states of anovulation and threatening women's health. We reviewed its main adverse effects and mechanisms on accelerated ovarian aging, mental health (emotional disruptions, depression, and suicide), sexuality (reduced libido), cardiovascular (brain stroke, myocardial infarction, hypertension, and thrombosis), and oncological (breast, cervical, and endometrial cancers). Other "collateral damage" includes negative effects on communication, scientific mistrust, poor physician-patient relationships, increased patient burden, economic drain on the healthcare system, and environmental pollution. Hormone-sensitive tumors present a dilemma owing to their potential dual effects: preventing some cancers vs. higher risk for others remains controversial, with denial or dismissal as non-relevant adverse effects, information avoidance, and modification of scientific criteria. This lack of clinical assessment poses challenges to women's health and their right to autonomy. Overcoming these challenges requires an anthropological integration of sexuality, as the focus on genital bodily union alone fails to encompass the intimate relational expression of individuals, complete sexual satisfaction, and the intertwined feelings of trust, safety, tenderness, and endorsement of women's femininity.

Informed Consent · Decision Making Support

Evaluation of a fertility awareness-based shared decision-making tool part 2: Patient experiences

Duane M et al., 2023 PEC Innov Open Access

To assess patient experiences using a Shared Decision-Making (SDM) Tool for fertility awareness-based methods (FABMs) of family planning. The study employed a prospective crossover design to evaluate impact of the SDM tool compared to usual practice when discussing FABMs with patients. Patients completed preand post-office visit surveys and an online survey six months later. The primary outcomes evaluated the effect of the SDM tool on patient satisfaction and FABM continuity of use rates. There was no significant difference in likelihood of changing family planning methods immediately after the office visit; however, by six months a significantly larger proportion of patients had started or changed FABMs in the experimental group (52%, 34/66) compared to the control group (36%, 24/66) (p = 0.04). Significantly more patients who used the tool and changed their FABM after their visit reported increased satisfaction with their FABM compared to control (50% vs. 17%, p = 0.022). Use of the SDM tool increased persistent use of and satisfaction with chosen FABMs at six months. The novel SDM tool can enhance patients' understanding and facilitate the selection of a more suitable method leading to increased satisfaction.

Reproductive Ethics · Third Party Reproduction

Defining embryo donation: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2023 Fertility and sterility

Building families through the adoption of children has been supported by human society throughout history. The ethical appropriateness of patients donating embryos to other patients for family building, or for research, is well established and is affirmed by this Committee. The use of the term ''adoption'' for embryos is inaccurate and should be avoided. This document replaces the ASRM Ethics Committee statement by the same name, last published in 2016.

Informed Consent · Decision Making Support

Informed consent in assisted reproduction: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2023 Fertility and Sterility

Informed consent is a process in which the patient is supported in developing an understanding of medical options (including risks, benefits, and alternatives) and coming to a voluntary and autonomous decision.

Policy and Regulation · Professional Standards

Rapport annuel d'activité 2022 - Agence de la biomédecine

Agence de la biomédecine, 2023 Agence de la biomédecine

Rapport annuel d'activité 2022 de l'Agence de la biomédecine. Annual activity report covering Agence de la biomédecine activities including AMP (Medically Assisted Reproduction) registry operations for 2022.

Reproductive Ethics · Embryo Status

Assisted Reproductive Technology and Natural Law: How Seven Years as an Embryologist Revealed IVF's Disordered Approach to Patient Care

Turczynski C et al., 2022 Linacre Q Open Access

This article is a case study illuminating the experience of a cradle Catholic who pursued a career in the field of Assisted Reproductive Technology (ART) as a laboratory director and embryologist. Twenty years after leaving the field, the observations leading to the crisis of conscience are further amplified by the reports of social, legal, ethical, and medical consequences of the technology. These consequences are explored in detail and can serve as a mini-review of the published scientific literature describing the obstetrical complications, peri-natal outcomes, and the long-term health effects on the offspring. This paper provides the documented evidence that can be used by the religious and medical community for shepherding the flock. The disordered approach to patient care is evidenced by five serious consequences resulting from the use of the technology. These include multiple pregnancy and selective reduction, abandoned and discarded embryos, adverse health effects to the women and children, legal and ethical problems, and human experimentation. An explanation for the adverse consequences can be found by exploring and applying the principles of Natural Law. Natural Law, as embraced by the Catholic Church, can be used as a starting point for conversion of heart for many who struggle with the immorality of ART. Deterring use of the technology coupled with increased motivation by scientist and health professionals to pursue restorative approaches within a moral framework offer our best solution to the treatment of infertility. Natural Law and the consequences of violating it provide evidence that science and medicine should not be practiced in a vacuum void of ethical and moral boundaries grounded in divine Wisdom.

Informed Consent · Decision Making Support

Patient informed choice in the age of evidence-based medicine: IVF patients' approaches to biomedical evidence and fertility treatment add-ons

Perrotta M et al., 2022 Sociol Health Illn Open Access

With the increasing offer of fertility treatment by a largely privatised sector, which has involved the proliferation of treatment add-ons lacking evidence of effectiveness, In-Vitro Fertilisation (IVF) patients are expected to make informed choices on what to include in their treatment. Drawing on interviews with 51 individuals undergoing fertility treatment, this article explores patients' approaches to medical evidence interpretation and its role in their decisions to include add-ons. While most IVF patients share understandings of what counts as medical evidence, our findings show how their approaches also differ. Our analysis focuses on how patients negotiate the notion of medical evidence and its relation to other forms of experience or knowledge. We present four different approaches to evidence in (1) delegating evaluations of evidence to experts; (2) critically assessing available evidence; (3) acknowledging the process of making evidence; and (4) contextualising evidence in their lived experience of infertility. We suggest that patients' choice to include add-ons is not due to a lack of information on or understanding of evidence, but rather should be interpreted as part of the complexity of patients' experiences of infertility.

Reproductive Ethics · Conscience Protections

Reproductive Services and Conscience-Based Refusals in Obstetrics and Gynecology Training

Kalinowski K et al., 2022 Linacre Q

Professional bodies such as the American College of Obstetrics and Gynecology recognize the impact of conscience-based decisions. The first time such decisions affect patients and providers is in residency. Our study sought to determine the attitudes of program directors towards various conscience-based refusals in potential applicants to obstetrics and gynecology programs. An eight-question survey was sent to 279 directors of U.S. obstetrics and gynecology residencies in 2019. The survey proposed hypothetical conscientious refusals of common aspects of obstetric and gynecology practice. The survey asked respondents to categorize their reaction to these choices and choose from a list of factors which could modify their reaction. Univariate analysis and multivariate logistic regression were performed. 97 program directors (35%) responded. A majority of PDs reported that the inability to prescribe or counsel on birth control, to provide methotrexate, to counsel on abortion, or to clearly enumerate refusals was impossible to work around, likely to lower an applicant's rank, not compatible with training, or not good for patients; collectively, these responses were grouped as "negative reactions" (73-99%). Female program directors had more negative reactions to applicants who refused to prescribe birth control (aOR 15.8, 95% CI 1.7-99.5) and counsel on abortion (aOR 3.6, 95% CI 1.2-10.8). Directors from different locations and program types did not have significantly different responses. A few program directors identified that academic strength could mitigate otherwise negatively-viewed choices. Illustrative comments of directors' attitudes are provided. Program directors agree that conscientious refusal to participate in certain activities is problematic for obstetrics and gynecology residency. There are very few subjective or regional differences on this stance, and few aspects of an application modify directors' reactions.

Reproductive Ethics · Embryo Status

The use of polygenic risk scores in pre-implantation genetic testing: an unproven, unethical practice

Forzano F et al., 2022 Eur J Hum Genet

Polygenic risk score analyses on embryos (PGT-P) are being marketed by some private testing companies to parents using in vitro fertilisation as being useful in selecting the embryos that carry the least risk of disease in later life. It appears that at least one child has been born after such a procedure. But the utility of a PRS in this respect is severely limited, and to date, no clinical research has been performed to assess its diagnostic effectiveness in embryos. Patients need to be properly informed on the limitations of this use of PRSs, and a societal debate, focused on what would be considered acceptable with regard to the selection of individual traits, should take place before any further implementation of the technique in this population.

Policy and Regulation · Professional Standards

Rapport annuel d'activité 2021 - Agence de la biomédecine

Agence de la biomédecine, 2022 Agence de la biomédecine

Rapport annuel d'activité 2021 de l'Agence de la biomédecine. Annual activity report covering Agence de la biomédecine activities including AMP (Medically Assisted Reproduction) registry operations for 2021. Provides governance and operational context for the French national ART registry.

Reproductive Ethics · Third Party Reproduction

Catholic Approaches to Procreation and Infertility

Lee P et al., 2021 Religion and Human Rights

Infertility is a worldwide problem today. The more conventional approach of medicine would be to diagnose the causes and correct them, so that the fertility potential of the couple would permit them to conceive naturally. However, since the advance of Assisted Reproductive Technologies, it has become a lucrative industry that seek to help anyone to procure a child. Lately, natural procreative processes such as NaProTechnology have arisen that can restore couples’ fertility potential through proper diagnosis and treatment. The Catholic Church prefers these latter approaches not only because they are truer to the nature of medical practice, but because they are more consistent with a healthy vision of human sexuality, procreation, and marriage.

Reproductive Ethics · Embryo Status

The ethics of assisted reproduction technology: A catholic perspective

Tham J, 2021 BUP Open Access

This paper looks at the ethics of assisted reproductive technology (ART) from the perspective of the Catholic Church. The three criteria of evaluation of the ethics of ART are the right to life and physical integrity of human beings, the unity of marriage, and the value of human sexuality. The paper examines the arguments based on these criteria carefully, as they apply to in vitro fertilization which is the most common ART method. It concludes that most ART methods would be unacceptable, but there are new alternatives like NaProTechnology that is promising for infertile couples.

Informed Consent · Decision Making Support

Informed Consent and Shared Decision Making in Obstetrics and Gynecology: ACOG Committee Opinion, Number 819

ACOG, 2021 Obstetrics and Gynecology

Meeting the ethical obligations of informed consent requires that an obstetrician-gynecologist gives the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment. Shared decision making is a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient's values and priorities. Some informed consent challenges are universal to medicine, whereas other challenges arise more commonly in the practice of obstetrics and gynecology than in other specialty areas. This Committee Opinion focuses on informed consent for adult patients in clinical practice and provides new guidance on the practical application of informed consent through shared decision making. The principles outlined in this Committee Opinion will help support the obstetrician-gynecologist in the patient-centered informed consent process.

Reproductive Ethics · Conscience Protections

Meeting Women's Requests for Intrauterine Device and Contraceptive Implant Discontinuation: An Exploratory Survey of Physicians

Kaneshiro B et al., 2020 Hawaii J Health Soc Welf

Long acting reversible contraceptives (LARC), including intrauterine devices (IUDs) and contraceptive implants, can support an individual in meeting their reproductive goals by allowing them to prevent pregnancy effectively. These devices can also limit an individual's control over reproduction because they generally require an in-person visit to a health care provider for removal. Returning for another visit may be logistically challenging for many individuals who may need to arrange for transportation, childcare, or take time off from work. Effectively negotiating with a provider to request removal may be additionally challenging for medically underserved and disenfranchised people who may not feel empowered to do so. The objective of this study was to assess providers' willingness to honor patients' requests for IUD and contraceptive implant removal on the day of the request. A survey was conducted in which clinicians were presented with scenarios of women requesting IUD or implant removal. Clinicians were asked what they were most likely to do. A total of 105 clinicians were surveyed. The responses of 60 clinicians who inserted IUDs and 57 who provided the contraceptive implant were included in the analysis. When asked about same-day removal of an IUD or implant from a dissatisfied patient who requested removal, 40% stated they would remove the implant, and 57% stated they would remove the IUD on the day of the request. Findings from this study suggest many clinicians would be unwilling or unable to accommodate a patient's request for device removal at the time of their visit. This delay or refusal represents a significant barrier for patients and has implications for reproductive autonomy that should be further explored.

Reproductive Ethics · Conscience Protections

Strangers in a Strange Land: How Our Founding Principles and a Bitter Pill Undo the Assimilation of US Catholics

Donovan GK et al., 2020 Linacre Q

Most Catholic physicians work with the comfortable assumption that we can practice our profession and our faith, fully assimilated into modern American culture and society. Increasingly, we have come to realize that to be a Catholic Christian is by nature to be countercultural. American culture, ordered by the founding fathers in concepts of liberty and freedom, has been profoundly affected by the introduction and reliance on a contraceptive pill. This has changed the mores and sexual behaviors of society in ways that are antithetical to Catholic values. The consequences of contraception have directly led to an acceptance of a broad number of behaviors and attitudes that society insists must be tolerated. This challenges the commitments of Catholic physicians both personally and professionally.

Reproductive Ethics · Embryo Status

Creating Catholic Regenerative Medicine Organizations in a Secular Biotechnology Field: A Physician-Scientist Experience

Moy A, 2020 Linacre Q

One aspect of the progressive secularization of biotechnology is the use of the by-products from abortion and the use of human embryos. These morally illicit cells and tissue create a significant moral and economic challenge for Catholics at different stages of their career. A practicing Catholic physician or scientific professional will face the dilemma of how to reconcile their Catholic identity with their profession. While the Catechism is clear on what actions Catholics should not pursue, there has been less religious guidance on what activities Catholics should proactively pursue in their professional life to advance the Catholic culture. This essay will examine these themes through the lens of a true story of the author's experience in starting Catholic for-profit and nonprofit biotechnology organizations. Abortion and the destruction of human embryos create a moral dilemma for Catholics at different stages of a physician or scientist's career. A practicing Catholic physician or scientist must reconcile their Catholic identity with their profession. While there is little professional guidance on how to advance the culture, Jesus says that one must take up the cross and direct their God-given gifts towards His name. The only way to succeed and thrive in a secular healthcare environment is to emulate Jesus by putting aside their own self-interest; pray for courage against ridicule; accept risk; and pursue scientific and medical excellence.

Reproductive Ethics · Conscience Protections

'Innate Nature' and 'Complete Nature': The Catholic Natural Family Planning Program and the Competition of Natural Methods in Mid-1970s Korea

Park S, 2020 Uisahak Open Access

This article reviews the competition of two natural family planning methods in the mid-1970s when the Catholic Natural Family Planning program was underway in Korea. The Catholic Church, emphasizing the natural law, has recommended Natural Family Planning (NFP), a method of regulating childbirth by abstinence during the fertile period, since the mid-twentieth century. However, a group of gynecologists working at St. Mary's Hospital, a Catholic general hospital in Korea, questioned the utility of NFP. As an alternative, they proposed the method of Ovulation Regulation (OR), which regulates the menstrual cycle by inducing ovulation with steroids agents. This seemed to be no different than contraception with oral contraceptives disapproved of by the Catholic Church, but many doctors who advocated OR thought that this could be a new 'natural' family planning method to replace NFP. What is noteworthy here is the fact that not only NFP advocates, but also OR advocates attempted to justify their methods based on the authority of the 'nature.' In the debate over natural family planning methods, nature's legitimacy was given premise, not the object of doubt. Rather, the issue was the definition of nature. First, 'nature' in NFP signifies 'innate nature,' which excludes human intervention. According to this point of view, OR with steroids agents could not be natural. On the contrary, a group of doctors who advocated OR considered nature 'primal completeness.' If the natural order of the menstrual cycle could be restored, the artificial intervention of the administration of steroids was not a problem. Thus, both groups defended their arguments by redefining nature, rather than raising an issue of nature itself. The competition between 'innate nature' and 'complete nature,' a proxy war between NFP and OR, resulted in the victory of the former as the meaning of nature became fixed. Advocates of NFP pointed out that OR inhibits other physiological functions in the process of inducing ovulation, suggesting that the idea of 'complete nature' could never be achieved. The meaning of nature could no longer be controversial. Since the intervention was unnatural, nature meant innateness, the absence of intervention. Accordingly, the Catholic Bishops of Korea approved the Billings Method, a kind of the NFP, as the official family planning method, and gynecologists at St. Mary's Hospital of Korea also focused on the development and supplementation of the Billings Method. In short, the debate over the methods of natural family planning in mid1970s Korea was a clash of 'innate nature' and 'complete nature.' As a result, this confirmed the limitations of medical practice and reconfirmed the power of magisterium, the church's authority over medical practice.

Reproductive Ethics · Embryo Status

Effects of Moral Fonts on Action and Decision Making

Furton EJ et al., 2020

This landmark publication is in its second edition has been completely revised and updated to reflect recent developments in magisterial teaching and scientific research. More than thirty authors, who are experts in their fields, examine moral action theory, key ethical principles, ethics committees, the embryo and fetus, contraception, reproductive technologies, difficult pregnancies, rape protocols, the determination of death, palliative care, nutrition and hydration, the persistent vegetative state, do-not-resuscitate orders, health care proxies, organ donation, vaccination refusals, genetic medicine, human experimentation, religious freedom, triage, cooperation with evil, state mandates, organizational ethics, and other topics. Catholic Health Care Ethics is an ideal resource for classroom use in colleges and universities, as well as in nursing schools and by ethics committees in hospitals and other health care facilities.

Reproductive Ethics · Embryo Status

Theological and Anthropological Analysi of Procreation in the Context of Contemporary Debate on Naprotechnology

Picur T, 2019 rt Open Access

Immersed in the world dominated by pragmatism, contemporary man seems to be thinking and functioning only according to the criteria of effective acting. However, life experience, philosophical reflection, and the truth of Revelation lead to the conclusion that the laws of nature must be respected in the name of care for man and for one’s genuine good, even though they may, in certain cases, limit the effectiveness of acting and the possibility to acquire current profit. This article justifies the necessity to respect natural law in the sphere of transmission of human life. The starting point of this scientific reflection is the theological vision of values and of the inviolability of human life on the basis of the description of creation from the Book of Genesis. The fundamental truths and moral norms are being neglected nowadays as—being so proud of modern technological achievements—man makes himself the creator and the master of human life. Although such activities seem impressive from the scientific point of view, they actually result in a number of serious contemporary and future threats. The second part of the article presents alarming aspects of artificial interventions in the sphere of life transmission. By exposing the threats and by trying to prevent them in the sphere of infertility treatment, the Church opposes the methods of artificial insemination and becomes engaged in promoting naprotechnology which is a method that expresses genuine humanism, and which gives hope not only to the parents who want to have a baby but also to the mankind that longs for propitious future.

Reproductive Ethics · Conscience Protections

Rejecting Humanae Vitae: The Social Costs of Denying the Obvious

Klaus H, 2018 Linacre Q

Since contraceptives have been used to remove fertility from the conjugal act, the social consequences predicted in the encyclical Humanae vitae, such as the rise in cohabitation, decline of marriage, rise of divorce, and single parenthood, have exceeded expectations. The degradation of the sexual act from total mutual self-giving to momentary union has led to doubting the significance of the biological truth of the body and opened the door to gender fluidity. Promiscuity became normative, and the need for consent became eroded until women revolted with the #MeToo movement. Promiscuity, cohabitation, and divorce have resulted in 40 percent of children born to unmarried parents whose tenuous unions often leave the children in melded and dysfunctional families. Relation-free "hookups" have become the norm among young adults, leaving a flood of emotionally damaged women, an epidemic of sexually transmitted infections, and unplanned pregnancies, to which the healthcare industry has responded by doubling down on the means which caused the problem in the first place with near-coercive promotion of long-acting, reversible contraceptives (LARCs). LARCs must be inserted and removed professionally and make reproductive choice moot. Respecting the truth of the body is the precise counter measure. A woman's cyclic fertility is easily observed with reliable biomarkers-natural family planning-which requires the whole person. Fertility awareness-based methods of family planning have no side effects, are easy to learn, and can be used to achieve as well as delay conception. The self-discovery inherent in learning fertility literacy has empowered adolescent girls and boys to understand and value their sexuality and fertility and avoid choosing harmful behaviors. Why does society continue to treat fertility as if it were a disease? Removing the idea of pregnancy from the sexual act as the result of readily available contraception has effectively limited choices about sexual behavior to the satisfaction of momentary desires. As Humanae vitae predicted, fewer marriages were contracted, divorce increased and now 40% of children are born out of wedlock despite extensive public education campaigns to promote contraception. Side effects of the hormonal pill have reduced their use so health care professionals have doubled down, providing long acting contraceptives which do not require the user to exercise choice before each act of intercourse, or of taking a pill. There is a much better way to regulate births-to learn to read the book of nature. Fertility is not a disease to be removed from the body. All that is needed is to understand the natural signs of fertility-natural family planning, now called FABM-Fertility Awareness-Based Methods. These have no side effects, enhance couple communication and offer effective choice for child spacing and demonstrably support premarital chastity for teens.

Informed Consent · Disclosure of Risks

Hormonal Contraception and the Informed Consent

Hilger DJ et al., 2018 Linacre Q

Since the 1960s, hormonal contraceptives have become the most commonly used method of pregnancy prevention in the United States and the world. Oral contraceptives are used by a large percentage of women, including Christian women. There are known health risks to women demonstrated in research published since Pope Paul VI's prophetic encyclical Humanae vitae in 1968. These risks include venous thrombosis, cardiovascular risks, and an increased risk of cancer. These risks are medically recognized with continued scientific debate on the degree. The risks are significantly increased with preexisting conditions and in certain demographic groups. Discussing known and potential treatment risks is a standard that is both accepted by the medical community and is increasingly expected by patients. This discussion can be accomplished by the mechanism and principle of informed consent. Depending on the circumstances, abstinence or fertility awareness-based methods (FABMs) should be presented to patients. FABMs are licit, safe, and effective methods of pregnancy prevention. Informed consent is the most effective means of providing patients with pertinent information on the significant risks of contraception. This article discusses the use of the informed consent to provide patients with information on the medical and ethical risks of oral contraceptives. FABMs and abstinence are presented as effective, safe, and licit preferences to oral contraceptives. Discussing known and potential treatment risks is accepted by the medical community and expected by patients (shared decision making). The authors discuss the historical context of Pope Paul VI's encyclical Humanae vitae in relationship to the development and rapid adoption of oral contraceptives.

Reproductive Ethics · Third Party Reproduction

Bioethical and Moral Perspectives in Human Reproductive Medicine

Turner JV et al., 2018 Linacre Q

A reductive reading of Humanae vitae seeks to limit its appeal to a ban on contraception. In truth, however, it offers a vision of human sexuality and conjugal love with broad and enduring relevance. In setting forth the intrinsic complementarity and irreducibility of the unitive and procreative dimensions of the conjugal act, Paul VI has given us a hermeneutical key for assessing many contemporary ethical dilemmas in human reproductive medicine. From this perspective, this article seeks to apply the logic of Humanae vitae to several real-life scenarios confronted by medical practitioners, educators, and ethicists working in the field of fertility and reproductive health. These include a consideration of the ethics of prescribing hormonal contraceptives, the possibilities of investigating male infertility, issues of cooperation in counseling and assisting conception in same-sex relationships, the ethics pertaining to assisted reproductive technology (ART), the contested case of prenatal adoption, and the application of double-effect reasoning. On the occasion of the fiftieth anniversary of the promulgation of Pope Paul VI's encyclical Humanae vitae, this article seeks to defend its enduring relevance to modern-day society, through application of its reasoning to contemporary dilemmas in reproductive medicine. It considers real cases of the ethics of prescribing hormonal contraceptives, of investigating male infertility, of cooperating in counseling and assisting conception in same-sex relationships, of ART, of prenatal adoption, and the application of double-effect reasoning.

Reproductive Ethics · Embryo Status

The Ethics of Interstitial and Cesarean Scar Ectopic Pregnancies: Four Case Studies and a Review of the Literature

Buskmiller C, 2018 Linacre Q

Catholic bioethicists have extensively addressed extrauterine tubal pregnancies, which represent the great majority of ectopic pregnancies. However, additional management options have been developed for the other 7-10 percent of ectopic pregnancies. Using two cases of interstitial pregnancy and two cases of cesarean scar pregnancy (CSP) seen at a Catholic tertiary care center, this article discusses options including expectant management, systemic methotrexate, intragestational methotrexate, intragestational potassium chloride, uterine artery embolization, dilation and curettage (D&C), vasopressin use, cornuostomy, cornual wedge resection, CSP evacuation, CSP scar excision, CSP salvage, and hysterectomy. Cornual wedge resection, vasopressin use, and CSP scar excision are morally acceptable; less clearly licit are aspiration of gestational sac contents, cornuostomy, gestational excision for CSPs, and methotrexate. Certainly illicit are any techniques leading to direct abortion such as D&Cs on live embryos or fetuses, double-balloon catheter placement, and use of potassium chloride. An ectopic pregnancy is any pregnancy outside the uterus. These are dangerous because the pregnancy can burst out of its abnormal location and cause life-threatening internal bleeding. Most are in the part of the fallopian tube outside the uterus, but there are other types, including interstitial pregnancies (located in the part of the tube tunneling through the uterine wall) and cesarean scar pregnancies (buried in the uterine scar where the cut for a C-section was made). This article lists the ways that physicians prevent women from dying from interstitial and cesarean scar pregnancies and proposes which treatments are morally acceptable.

Reproductive Ethics · Conscience Protections

Teaching OB/GYN residents bioethics within a Catholic healthcare context

Steele A, 2017 Issues Law Med

Residents entering training in the specialty of Obstetrics and Gynecology (OB/GYN) often have misconceptions as to what medical interventions Roman Catholic healthcare institutions prohibit, and why certain restrictions are placed on the provision of reproductive health options that are otherwise legally available to women. The Ethical and Religious Directives for Catholic Healthcare Services, produced by the United States Conference of Catholic Bishops seeks to provide a stable framework upon which reproductive health decisions can be based. However, Catholic healthcare ethics may conflict with secular bioethical assertions that place a premium on autonomous patient choice. Residents training in part or whole at a Catholic institution may feel frustration at what they perceive to be a conflict with current secular ethics paradigms-such as access to abortion, contraception, sterilization, and assisted reproductive technologies. The recent adoption of Clinical Competencies by the Accreditation Council for Graduate Medical Education (ACGME), directs that residents shall be trained to function within the framework of their larger healthcare system ("Systems-based Practice"). This article will first, clarify areas of conflict and convergence between Catholic and secular reproductive ethics, which are unique to OB/GYN training. Next, using the ACGME's new Clinical Competency in Systems-Based practice as a model, a rationale for incorporating Catholic Healthcare ethics into an ethics curriculum for OB/GYN residents will be discussed. Finally, guidelines for faculty tackling the problem of how to teach Catholic Healthcare ethics will be described. Incorporating the rich tradition of Catholic healthcare ethics into the educational curriculum of OB/GYN residency fulfills training requirements while exposing young physicians to a rational decision-making framework in bioethics.

Reproductive Ethics · Conscience Protections

Committee Opinion No. 664: Refusal of Medically Recommended Treatment During Pregnancy

ACOG, 2016 Obstetrics and Gynecology

One of the most challenging scenarios in obstetric care occurs when a pregnant patient refuses recommended medical treatment that aims to support her well-being, her fetus's well-being, or both. In such circumstances, the obstetrician-gynecologist's ethical obligation to safeguard the pregnant woman's autonomy may conflict with the ethical desire to optimize the health of the fetus. Forced compliance-the alternative to respecting a patient's refusal of treatment-raises profoundly important issues about patient rights, respect for autonomy, violations of bodily integrity, power differentials, and gender equality. The purpose of this document is to provide obstetrician-gynecologists with an ethical approach to addressing a pregnant woman's decision to refuse recommended medical treatment that recognizes the centrality of the pregnant woman's decisional authority and the interconnection between the pregnant woman and the fetus.

Reproductive Ethics · Conscience Protections

Apply the Precautionary Principle Concerning Combined Hormonal Contraception Use in Adolescents

Prior JC, 2016 Women's Reproductive Health

Here I respond to Akers, Dhar, and Shah's (2016), Stubbs's (2016), Olshansky's (2016), and Kissling's (2016) commentaries on the article (Prior, 2016) in which I expressed concerns about the potential adverse long-term reproductive and bone health effects on normal adolescents’ maturation related to use of combined hormonal contraceptives (CHC) for contraception and/or treatment. Although Akers et al. (2016) take exception, the precautionary principle on which medical/pharmaceutical ethics is based challenges us to show that CHC is officially indicated and effective in randomized, double-blind, placebo-controlled trials with adolescents. Those who support current practices are obligated to provide young patients and their parents with evidence from large, population-based, prospective studies (or meta-analyses of longitudinal data) that adolescents who have used CHC develop the same menstrual cycle/ovulatory function, fertility, and reproductive lifespan and similar bone density and strength as peers who did not use CHC. Without this information there can be neither reproductive justice (Kissing, 2016), nor true choice. Why is this minimal, expected scientific data not available? It is likely that authors of practice guidelines for adolescent CHC contraceptive use and who advocate its “non-contraceptive benefits” have pro-estrogen cultural biases or conflicts of interests due to pharmaceutical industry connections. I agree with Olshansky (2016) that we should listen to adolescents’ concerns and use evidence-based and safe treatments for milder heavy bleeding and cramps. For heterosexual adolescents seeking contraception, we can suggest and explain the use of safer, yet effective, nonhormonal strategies, such as the copper IUD or a barrier plus full-dose vaginal spermicide.

Reproductive Ethics · Embryo Status

THE EVALUATION OF INFERTILITY TREATMENT AND APPLICATION OF ASSISTED REPRODUCTION IN THE ASPECT OF HUMAN DIGNITY

Obelenienė B et al., 2016 SJRS Open Access

The article raises the issue of today’s application of assisted (artificial) reproduction methods, which are incom-patible with human dignity. The authors articulate the principles of human dignity, which are formulated as an evaluation tool of criteria and them revealing system of indicators in the assessed object. The article compares Naprotechnology as a contemporary holistic method of diagnosis and treatment of infertility, which comprises therapeutic, surgical and fertility awareness method, with methods of assisted reproduction and identifies their medical and ethical differences. The project of the Assisted Reproduction Law of the Republic of Lithuania is evaluated in the aspect of human dignity as well.

Reproductive Ethics · Embryo Status

The Principle of Double Effect in Ethics: A Review

Hinman LM, 2016

- A pregnant woman is diagnosed with uterine cancer. Is it permissible to operate to remove the cancer, even though doing so will result in the loss of the baby? - A dying man is in extreme pain. Is it permissible to administer large doses of morphine to reduce the pain, even though doing so will shorten the amount of time the man has left to live? - A country has been attacked by another. Is it morally permissible for the country that has been attacked to respond by, among other things, bombing its attacker’s industrial centers, even though doing so will also bring about the deaths of some civilian workers? Cases - A pregnant woman is diagnosed with uterine cancer. Is it permissible to operate to remove the cancer, even though doing so will result in the loss of the baby? Supporters of the principle of double effect will argue that it is permissible to remove the cancerous uterus (thus also terminating the pregnancy) if this is the only way to stop the spread of the cancer and if the physician does not intend to end the pregnancy, only to remove the cancer. The good effect (removal of the cancer) does not follow from the bad effect (termination of the pregnancy). - A dying man is in extreme pain. Is it permissible to administer large doses of morphine to reduce the pain, even though doing so will shorten the amount of time the man has left to live? Again, defenders of the principle of double effect will argue that, since the genuine intent is only to relieve the pain and since there is no other way to accomplish this goal, large doses of pain killers may be permitted even though they will hasten the inevitable end of the patient's life. - A country has been attacked by another. Is it morally permissible for the country that has been attacked to respond by, among other things, bombing its attacker’s industrial centers, even though doing so will also bring about the deaths of some civilian workers? The principle of double effect has been a cornerstone of the wartime policy of many countries, including the United States. Indeed, long range strategic bombers (such as the B-52) are essentially weapons for the mass destruction of civilian populations. Both the atomic bombs dropped on Japan were dropped on civilian centers. The Arguments The principle of double effect finds its natural home in deontological, non-consequentialist moral theories, since it turns very specifically on the intention of the moral agent. Utilitarianism and other consequentialist doctrines give little or no weight to the agent’s intentions, and as a result the principle of double effect makes little sense within such theories. We will see a similar issue arise when we discuss the difference between killing and letting die, a distinction that is much more meaningful within deontological theories than consequentialist ones. Typically, for an act to qualify as morally permissible under the principle of the double effect, a number of conditions must be met: - The act must be morally good or at least morally neutral; - The agent must intend only the good effect, nor the bad effect; - The good effect cannot be the causal result of the bad effect; - There must be a proportionately serious reason for permitting the evil effect; - There must not be any other, less morally troubling way of accomplishing the good effect.

Reproductive Ethics · Conscience Protections

How Humanae vitae has advanced reproductive health

Doroski DM, 2014 Linacre Q

By encouraging doctors and scientists to improve the regulation of births through the observation of natural fertility rhythms, Humanae vitae promoted the development of natural family planning (NFP). The study of NFP has lead to NFP-based methodologies in reproductive healthcare that are promoting advances in treatment of infertility, miscarriage, and a number of reproductive health disorders. In contrast, the contraceptive mentality has stunted the development of reproductive healthcare. Humanae vitae has provided a great gift to science and reproductive healthcare that all Catholics should be proud of.

Reproductive Ethics · Conscience Protections

Ethical Problems in the Use of Hormonal Contraception

Laurinec J, 2014 Natl Cathol Bioeth Q

The development of hormonal contraception introduced a new era in medical practice, marked by the suppression of female fertility by interventions in the hormonal system. The interventions are very grave, as sex hormones are of existential importance both to preserve human life and to preserve the human species. This article conducts an ethical evaluation of the use of hormonal contraception through two ethical theories: natural law theory and virtue ethics. Based on philosophical reflection, the author examines what effects hormonal contraception has on primary goods and whether its use is congruent with the cardinal virtues. National Catholic Bioethics Quarterly 14.3 (Autumn 2014): 491–524.

Reproductive Ethics · Embryo Status

Levonorgestrel in cases of rape: How does it work?

Raviele KM, 2014 Linacre Q

The Ethical and Religious Directives for Catholic Health Care Services allows the use of an emergency contraceptive for a woman who has been raped, as a defense against her attacker's sperm, provided the drug prevents fertilization and does not act against a conceived human life. Catholic emergency rooms around the country have been pressured to provide Plan B (LNG-EC) to patients seeking help after a sexual assault. Catholic bioethicists have supported the use of this drug based on their interpretation of the scientific literature regarding its mechanism of action. This paper presents a review of the mechanisms of action of LNG-EC when given during the fertile window, showing a high probability that it acts against human life rather than preventing fertilization, and proposes another class of drugs as a possible alternative.

Advocacy and Public Understanding · Patient Advocacy

Practical resource for creating a Catholic living will

Yeung PP Jr, 2014 Linacre Q

Dear Editor, I read with interest the recent issue of the Linacre dedicated to geriatrics and end-of-life care. This is such a timely topic! With the implementation of Obamacare – which is government-run health care funded at the rate of economic inflation, not the more rapidly increasing healthcare inflation – there will be ever-increasing healthcare rationing. This will lead to escalating pressure to withhold life-preserving treatment (including food and water) especially to vulnerable populations including the elderly, the disabled, and the poor. As a result, end-of-life documents are already incredibly important and will become ever moreso. The article by Dr. Morrow articulates several key principles that should be present in an end-of-life document that adheres to Catholic principles – one that recognizes and respects the inherent dignity for human life for its own sake, one that ensure ordinary care and comfort care, and one that is “personalized” by appointing a healthcare proxy who understands and can implement your wishes according to the situation at hand. While there are several end-of-life document templates available, most do not adhere to the principles outlined in Dr. Morrow's article. A practical, easy-to-use resource for developing an end-of-life document that adheres firmly to the principles outlined in Dr. Morrow's article is the Will To Life Project developed by the National Right To Life Committee. From this website, one can download a legally valid document for any of the fifty states. While creating a Catholic end-of-life document can be daunting, this resource provides a practical starting point and a template anyone can complete. For more information, check out: http://www.nrlc.org/medethics/willtolive/.

Reproductive Ethics · Conscience Protections

Spiritual Care of Couples Practicing Natural Family Planning

Fehring RJ et al., 2013 Linacre Q

There are few studies that have investigated the spiritual problems of couples practicing natural family planning (NFP). The purpose of this paper is to analyze the spiritual problems and interventions of couples who were taught NFP by means of a professional online Web-based support system. Responses from this online system and its forums were categorized according to spiritual responses, spiritual problems, and spiritual interventions to the practice of NFP. Themes addressed included spiritual care in regards to decisions about the transmission of new life, difficulties in dealing with chastity and abstinence, bioethical problems related to pregnancy and illness, end of the reproductive life decisions, ethical treatment of women's health problems, sacrifice, and personal and relational struggles. Online community support, help in building confidence in NFP methods, and bioethicist referral are key interventions. The complexity of these spiritual responses, problems, and appropriate interventions require the expertise of health professionals in cooperation with bioethicists. We concluded that NFP can be viewed as both a spiritual practice and a means of spiritual growth.

Reproductive Ethics · Conscience Protections

NaProTECHNOLOGY and Conscientious OB/GYN Medicine

Jemelka BE et al., 2013 Virtual Mentor

In the last 50 years, a surge of reproductive technology has revolutionized the practice of obstetrics and gynecology. First, effective hormonal contraceptives were made available to the public in the 1960s and, since their debut, have been used to treat almost every gynecologic abnormality [1]. Second, in the past 30 years, infertility has largely been managed using assisted reproductive technologies (ART), primarily intrauterine insemination (IUI) with recourse to in vitro fertilization (IVF) when insemination fails [2]. As a result, the modus operandi in mainstream gynecology has been to suppress, or to bypass, the woman’s fertility cycle. Physicians and patients who (1) conscientiously object to the therapeutic use of hormonal contraceptives on the grounds that it subjects patients to ineffective treatment of symptoms rather than treating their underlying disease and (2) morally oppose the ART approach to infertility on the grounds that it jettisons a loving act of marital intercourse, the one context worthy of the conception of a new human being, are now able to pursue an alternative approach that accords with their consciences. NaProTECHNOLOGY (an acronym for natural procreative technology) is a woman’s health science that encompasses a unique medical and surgical application of gynecology. The foundation of NPT is the Creighton Model FertilityCare System (CrMS), see Figure 1, the only prospective and standardized means of monitoring the various patterns of a woman’s menstrual and fertility cycle for the natural regulation of fertility. For example, because it views infertility as a symptom rather than a disease, NPT seeks to diagnose and treat the underlying causes of infertility so that the couple can more successfully conceive within their own acts of intercourse, especially during peak-day-focused intercourse. NPT infertility protocols depend on patient-specific charting data. Some observations during the fertility cycle—dry, limited, or continuous mucus; short or variable post-peak phase; premenstrual spotting or tail-end brown bleeding—are external signs of possible underlying disease processes. A medical interpretation of these abnormal CrMS observations leads to a targeted biochemical and hormonal evaluation, which in turn identifies target organ dysfunctions: decreased production of estrogenic cervical mucus, intermenstrual bleeding or spotting, short or variable luteal phases, and suboptimal levels of the ovarian hormones (estrogen or progesterone). Common treatments for these pathologies include induction or stimulation of ovulation, medications to enhance cervical mucus, and hormonal support in the luteal phase. When these NPT medical approaches to infertility were used in a study of 1,239 infertile couples, they resulted in a live birth rate similar to that of cohort ART treatments [3]. In many cases, medical applications of NPT are sufficient to treat infertility successfully; in other cases, surgical intervention is also required. Surgical NPT is a specialized form of gynecologic surgery the primary aim of which is to reconstruct the uterus, fallopian tubes, and ovaries. The ovarian wedge resection (surgical removal of a portion of an enlarged ovary to restore its normal size), for example, is effective in healing polycystic ovaries (contributing to the long-term treatment of some of the endocrine and menstrual cycle abnormalities associated with polycystic ovaries). It also brings the patient a 70 percent chance of pregnancy i.e., it is twice as effective as clomiphene [4]. A significant benefit of surgical NaProTECHNOLOGY is “near adhesion-free” surgery. One of the biggest pitfalls of surgery, of course, is the formation of postoperative adhesions, which can decrease tubal motility (adversely affecting fertility) and cause small bowel obstructions (that frequently require emergency reoperation) [5]. To prevent these complications, NPT surgical techniques pay meticulous attention to detail, take a systematic approach, and use Gore-Tex adhesion barriers [6]. Published Gore-Tex protocols reveal a statistically significant decrease in subsequent adhesion scores on second-look laparoscopy [7]. For some reason, the use of Gore-Tex has been overlooked in even the most recent adhesion prevention reviews [8]. One even laments that adhesion prevention is a “surprisingly neglected aspect of the treatment of endometriosis,” but the reviewers make no mention of the use of Gore-Tex as an adhesion barrier. Other techniques of surgical NPT include laser vaporization and pelvic excision and repair surgery (PEARS) of peritoneal or ovarian endometriosis. PEARS is a form of plastic reconstructive surgery of the pelvis with the primary intent of removing diseased tissue within the pelvic organs and repairing organs in a way that does not form pelvic adhesions. PEARS can entail robot-assisted laparoscopy or laparotomy, minimizing postoperative adhesions and optimizing the patient’s chances for pregnancy. The effectiveness of treating infertility with medical and surgical NPT is comparable to that of ART interventions. The cumulative live birth rate in patients receiving IVF is between 45-55% [10]. In a study population of 1,045 patients treated with NPT infertility protocols, more than 60 percent became pregnant within 24 months and nearly 70 percent within 36 months [11]. The overall �per-woman� NPT pregnancy rate is higher than that of ART due, in part, to the high rate of dropout or discontinuation in patients who undergo IVF treatment [12]. In addition, a meta-analysis comparing conventional surgery and IVF for treatment of endometriosis-related infertility found that the per-woman pregnancy rates with surgery were 55.3 percent while those with IVF were 9.9 percent [13]. However, while it is true patients treated with NPT have significantly lower overall fecundability (a 3.13 percent chance of conceiving within a given period) than those treated with IVF (13.3 percent), it is also true that the number of women who ultimately achieve a pregnancy with NPT is higher than the number who get pregnant using ART [14]. Thus, although achieving a live birth with NPT may take longer, it has a greater chance of occurring than with IVF. For those interested in training in NPT, the Pope Paul VI Institute and Creighton University School of Medicine offer educational programs for those in primary care or ob/gyn (including fourth-year medical students) to train in the medical applications of NaProTECHNOLOGY [15]. They also offer a 1-year fellowship in the surgical applications of NPT for ob/gyns who have completed their residencies [16].

Reproductive Ethics · Third Party Reproduction

The ethics of uterus transplantation

Catsanos R et al., 2013 Bioethics

Human uterus transplantation (UTx) is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies (ART) and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as face and limb grafts, and shares some of the ethical concerns raised by these non-life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx.

Policy and Regulation · Access and Coverage Policy

Natural Family Planning Instruction as a Marriage Requirement a Retrospective Analysis of the First Two Years' Experience in the Diocese of Covington()

Manhart MD, 2012 Linacre Q

Beginning January 1, 2009, the Roman Catholic Diocese of Covington mandated that all engaged couples take a full course of NFP instruction as part of preparation for marriage within the Church. Using data from the Couple to Couple League and its Covington-based instructors, overall NFP instruction and characteristics of the couples attending classes before and after the mandate were examined. In the first two years, 66 percent and 77 percent of couples who married in the diocese, respectively, attended an NFP class. The mandate shifted the reasons for couples taking NFP instruction; prior to the mandate, 40 percent of engaged couples attended classes solely due to a pastor's requirement while 74 percent of engaged couples did so afterward (p < 0.001). Hormonal contraceptive use was common; 54 percent reported current use while another 23 percent reported former use. Current hormonal contraceptive use was significantly more common among those attending solely due to the mandate compared to those attending for multiple reasons (59 percent vs. 41 percent respectively, p = 0.004) and was significantly more common among engaged compared to married couples (53 percent vs. 8 percent respectively, p < 0.001). Cohabiting engaged couples were significantly more likely to have ever used hormonal contraceptives (91 percent vs. 71 percent, p < 0.0001), compared to engaged couples who were not cohabiting at the time of NFP instruction, and were significantly less likely to both be Catholic (55 percent vs. 70 percent, p = 0.002). Overall, implementation of mandatory NFP instruction as part of marriage preparation was successful; in post-class surveys, over 90 percent of couples acknowledged they had a better understanding of their fertility, and 83 percent would recommend the classes to a friend. Longer-term prospective follow-up is needed to evaluate the long-term impacts to couples exposed to such a requirement.

Advocacy and Public Understanding · Media and Representation

The commercialization of robotic surgery: unsubstantiated marketing of gynecologic surgery by hospitals

Schiavone MB et al., 2012 American journal of obstetrics and gynecology

We analyzed the content, quality, and accuracy of information provided on hospital web sites about robotic gynecologic surgery. An analysis of hospitals with more than 200 beds from a selection of states was performed. Hospital web sites were analyzed for the content and quality of data regarding robotic-assisted surgery. Among 432 hospitals, the web sites of 192 (44.4%) contained marketing for robotic gynecologic surgery. Stock images (64.1%) and text (24.0%) derived from the robot manufacturer were frequent. Although most sites reported improved perioperative outcomes, limitations of robotics including cost, complications, and operative time were discussed only 3.7%, 1.6%, and 3.7% of the time, respectively. Only 47.9% of the web sites described a comparison group. Marketing of robotic gynecologic surgery is widespread. Much of the content is not based on high-quality data, fails to present alternative procedures, and relies on stock text and images.

Reproductive Ethics · Third Party Reproduction

Eggs, ethics and exploitation? Investigating women’s experiences of an egg sharing scheme

Haimes E et al., 2012 Sociology of Health &amp; Illness Open Access

AbstractThere is a growing global demand for human eggs for the treatment of sub‐fertile women and for stem cell‐related research. This demand provokes concerns for the women providing the eggs, including their possible exploitation, whether they should be paid, whether they can give properly informed consent and whether their eggs and bodies are becoming commodified. However, few of the debates have benefitted from insights from the women themselves. We address this gap in knowledge by reporting on a study investigating women’s views and experiences of a scheme in which they can volunteer, in their capacity as fertility patients, to ‘share’ their eggs with researchers and receive a reduction in in vitro fertilisation fees. We focus our discussion on the question of exploitation, a concept central to many sociological and ethical interests. In brief, our analysis suggests that while interviewees acknowledge the potential of this scheme to be exploitative, they argue that this is not the case, emphasising their ability to act autonomously in deciding to volunteer. Nonetheless, these freely made decisions do not necessarily take place under circumstances of their choosing. We discuss the implications of this for egg provision in general and for understandings of exploitation.

Reproductive Ethics · Embryo Status

Direct Abortion or Legitimate Medical Procedure Double Effect?

Seeds JW, 2012 The Linacre quarterly Open Access

The distinction between direct abortion and legitimate medical procedures deemed necessary to save the life of the mother but resulting in the death of the unborn child challenge all clinicians and persons of faith. A careful analysis of the principle of double effect and a recent statement by the Committee on Doctrine of the United States Conference of Catholic Bishops offer some clarity to this difficult conflict. Two case examples offer illustration for the analysis.

Advocacy and Public Understanding · Public Awareness

Clinician perceptions of providing natural family planning methods in Title X funded clinics

Kelly PJ et al., 2012 J Midwifery Womens Health

Natural family planning (NFP) methods are effective for contraception with proper and consistent use. However, only 1% of patients at federally funded Title X family planning clinics select NFP as a contraceptive method. The goal of this study was to understand from clinicians' perspectives the barriers and facilitators to providing NFP methods. Six telephone focus groups were conducted with 29 clinicians from Title X clinics across the United States and Puerto Rico. A hermeneutic method was used to analyze data for related themes. The overarching theme from the study was that participants had a strong desire to teach their patients how their bodies work and to empower them to learn to control fertility. Four subthemes emerged: patient misinformation and misunderstanding about fertility; provider ideas about ideal types of candidates for NFP; inconsistent patient teaching strategies; and lack of time to teach NFP methods. There is a need for increased NFP training for providers and efficient NFP patient teaching strategies to meet the needs of patients with limited knowledge about fertility.

Reproductive Ethics · Embryo Status

Dignitas personae and the Adoption of Frozen Embryos: A New Chill Factor?

Grabowski JS et al., 2010 Natl Cathol Bioeth Q

The Congregation of the Doctrine of the Faith’s Dignitas personae does­not­offer­a­definitive­rejection­of­the­practice­of­human­embryo­adoption­as­ intrinsically­evil,­but­neither­does­it­simply­leave­the­matter­an­“open­question.”­ The document does indeed oppose the practice, but its reasons for doing so are not­clearly­stated­and­seem­to­be­in­tension­with­its­own­affirmations­of­the­ personal dignity of embryos and the goodness of adoption. The Congregation’s opposition is therefore best read as a prudential judgment that embryo adoption cannot­be­justified­in­the­present­circumstances­due­to­the­potential­for­scandal and the cooperation with the fertility industry which it involves. National Catholic Bioethics Quarterly 10.2­(Summer­2010):­307–328.

Policy and Regulation · Professional Standards

Impact of Catholic Health Care Directives on Ethics and Religion

USCCB, 2009

Executive Catholic Health is a ministry of the Church. Through the Ethical and Religious Directives for Catholic Health Care Services (ERDs), the Church reaffirms its commitment to the ministry of health care and the distinctive Catholic identity of the Church’s institutional health care services. The purpose of the ERDs are as follows: - To affirm the ethical standards that flow from the Church’s teaching about human dignity. - To provide authoritative guidance on some specific moral issues facing Catholic health care. - To provide professionals, patients and families with principles and guides for making decisions. These directives set some basic parameters as to how Catholic healthcare should be delivered and to which all are accountable. Part I: The social responsibility of Catholic health care services Catholic health care is guided by the following normative principles: - a commitment to promote human dignity, to care for the poor, to contribute to the common good, to be responsible stewards of available resources, and - to act in communion with the Church. Key Directives: - #1: We are a community of care animated by the Gospel and respectful of the church’s moral tradition. - #2: We act in a manner characterized by mutual respect among caregivers and serving with compassion of Christ. - #3: We distinguish ourselves by service to and advocacy for the marginalized and vulnerable. - #6: We are to use healthcare resources responsibly. - #7: We treat employees respectfully and justly (non‐discrimination in hiring, employee participation in decision‐making, a workplace that ensures safety and well‐being, just compensation and benefits; recognition of the right to organize). Part II: The pastoral and spiritual responsibilities of Catholic health care Catholic health care has the responsibility to treat those in need in a way that respects the human dignity and eternal destiny of all. Since a Catholic health care institution is a community of healing and compassion, care is not limited to the physical; it also embraces the psychological, social, and spiritual dimensions of the person. Hence, pastoral care is an integral part of Catholic health care. Key Directives: - #15: We address the holistic needs of persons. - #10: We ensure professional preparation and credentials for staff; address the particular religious needs of patients. - #10‐14, #20‐22: We respect proper authorities in each religion or Christian denomination regarding appointments. - #11, #22: We maintain an ecumenical staff or make appropriate referrals. - #10, 12‐20: We address the sacramental needs of Catholics. Part Iii: The professional‐patient relationship Mutual respect, trust, honesty, and confidentiality mark this relationship. Personal nature of care must not be lost even when a team of caregivers is involved in care. The dignity of the person is respected regardless of health problem or social status, (e.g., race, creed, color, national origin, ancestry, religion, sex, sexual orientation, marital status, age, newborn status, handicap, or source of payment). Key Directives: - #23: We respect and protect the inherent dignity of human person. - #24: We encourage and respect advance directives. - #25: We respect choices of surrogate decision makers. - #26, #27: We honor patients’ right to make treatment decisions; we respect informed consent. - #32: We respect decisions to forego treatment; distinction between ordinary or proportionate means (morally obligatory) and extraordinary or disproportionate means (morally optional). - #33: We consider whole person when deciding about therapeutic interventions. - #34: We respect privacy and confidentiality. - #36: We provide compassionate and appropriate care to victims of sexual assault. We cooperate with law enforcement officials; offer psychological and spiritual support; we offer “accurate medical information;” we provide treatment to prevent conception: pregnancy approach; ovulation approach. - #37: We are required to have an ethics committee or ensure some alternate form of ethical consultation is available. Part IV: Issues in care for the beginning of life The Church’s commitment to human dignity inspires an abiding concern for the sanctity of human life from its very beginning, and to the dignity of marriage and of the marriage act by which human life is transmitted. The Church’s defense of life encompasses the unborn and the care of women and their children during and after pregnancy. The unitive and procreative meanings of sexual intercourse must not be separated. Procreation is joined naturally to the marriage act. Any technique used to achieve conception by the use of gametes coming from at least one donor other than the spouses is prohibited. Key Directives: - #40, #41, #52, #53: We do not perform heterologous fertilization (AID), gestational surrogacy; homologous fertilization (AIH), IVF; contraceptive practices, direct sterilization. - #43: We do provide some infertility treatments. - #45: We do not provide abortions but provide compassionate care to those who have had an abortion. - #47: We perform (indirect abortions) procedures whose sole immediate purpose is to save the mother’s life, where the death of embryo or fetus is foreseen but unavoidable. - #50: We conduct prenatal diagnosis. - #53: We perform (indirect sterilizations) procedures that induce sterility when their direct effect is the cure or alleviation of a present and serious pathological and a simpler treatment is not available. - #54: We offer prenatal diagnosis and genetic counseling in order to promote preventive care and responsible parenthood. Part V: Issues in the care of the dying Catholic health care ministry faces death with the confidence of faith; it witnesses to the belief that God has created each person for eternal life. A Catholic health care institution will be a community of respect, love, and support to patients and their families as they face death. Effective pain management is critical in the appropriate care of the dying. We have a duty to preserve our lives, but that duty is not absolute. The use of medical technologies is judged in light of the Christian meaning of life, suffering, and death. Key Directives: - #55: We help patients prepare for death: provide necessary information for decision‐making; - #56‐57: We understand that a person may forgo extraordinary or disproportionate means of preserving life; no moral obligation to employ disproportionate or too burdensome treatments. - #58: We understand that there should be a presumption in favor of providing nutrition and hydration, including medically assisted, as long as the benefits it provides outweigh the burdens. - #59: We respect the free and informed judgment of competent patient to accept or refuse life‐sustaining treatment; - #60: We do not provide euthanasia and physician‐assisted suicide. - #61: We assure appropriateness of good pain management, even when death may be indirectly hastened through use of analgesics. - #63‐66: We encourage appropriate use of tissue and organ donation. Part VI: Forming new partnerships with health care organizations and providers New partnerships can be viewed as opportunities for Catholic health care institutions and services to witness to their religious and ethical commitments and so influence the healing profession. New partnerships can pose serious challenges to the identity of Catholic health care institutions and services. Scandal can result when partnerships are not built on common values and moral principles. - Intention: Intending, desiring or approving the wrongdoing is always morally wrong (formal cooperation). - Action: Participating in the wrongdoing or providing conditions for the evil to occur (material cooperation). - Material cooperation can be immediate or mediate. - Mediate material cooperation can be proximate or remote. Key Directives: - #67, #68: We consult with diocesan bishop or liaison if partnership could have serious impact on the Catholic identity or reputation of the organization, or cause scandal. We seek proper authorization. - #70: We are forbidden from engaging in immediate material cooperation in intrinsically evil actions (e.g., IVF, direct sterilization). - Immediate material cooperation with regard to partnerships would include ownership, governance, management, financial benefit, material and personnel support. - #71: We are required to consider “scandal” when applying the principle (means “leading others into sin” and not causing shock or discomfort; scandal may often be avoided by good explanation). - May foreclose cooperation even if licit. - The bishop has final responsibility for assessing and addressing scandal. - #72: We are required to periodically assess whether the agreement is being properly observed and implemented.

Policy and Regulation · Professional Standards

Human Fertilisation and Embryology Act 2008

United Kingdom Parliament, 2008

An Act to amend the Human Fertilisation and Embryology Act 1990 and the Surrogacy Arrangements Act 1985; to make provision about the persons who in certain circumstances are to be treated in law as the parents of a child; and for connected purposes. The 2008 Act updated the regulatory framework established in 1990 to reflect scientific and social developments. Key changes included: explicit provision for human admixed embryos (cytoplasmic hybrids) for research purposes; recognition of same-sex couples as legal parents following licensed treatment; replacement of the previous 'need for a father' welfare clause with 'supportive parenting'; tightened consent and withdrawal-of-consent provisions following the Evans judgment; expanded scope of pre-implantation genetic testing including saviour-sibling testing; statutory regulation of mitochondrial replacement (later activated via 2015 regulations); and enhanced parental order provisions for surrogacy. The 2008 Act maintained the HFEA's role as licensing authority and registry steward but reorganised offence definitions and licence conditions.

Informed Consent · Decision Making Support

The origin of informed consent

Mallardi V, 2006 Acta Otorhinolaryngol Ital

The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised, in the Hippocratic physician, that cared about the patient's suffering, but never neglected looking after his own outcome, endeavouring to avoid becoming involved in lack of success and death of a patient. The concept of consensus is inexistent, albeit, there is an awareness of the presence of precautious and preventive information. In the behaviour of doctors, in ancient times, it is not difficult to recognize the true motives and the real reasons that, already in those days, give rise to the necessary "defensive medicine" particularly as far as concerns the social status of the patient. Already from the early origins, continuing the Hippocratic tradition, the relationship between doctor and patient was consolidated, based upon two very definite criteria, represented, on the one hand, by the professional duty of the physician to do what is bestfor the patient and, on the other, the duty of the patient to completely accept the physician's decisions and intervention. The Hippocratic physician respected a principle of professional responsibility which was more religious and of a moral type, but, from a legal point of view, very weak inasmuch as it depended upon regulations elaborated by human beings. The conviction and certainty that the physician acted, in the interest of his patient's well-being, has been passed down over the centuries endowing the physician with moral authority and a kind of legal impunity, conditions which corresponded, in an almost reflection-likefashion, with the duty of obedience and subjection, on the part of the patient. Christianity was grafted into this consolidated vision of the sacral character of medicine and medical practice, which did not substantially change the Hippocratic type of ethical behaviour. Non only the population but also the Christian physician was aware of the religious importance of his intense activity as a mission and compared to a special kind of priesthood in safe-guarding health, considered as a gift of God. Therefore, invested with this authority which derived from his professional role and from his very work, he felt it his duty to guide the patient, deciding and for him. The patient is an ignorant person who does not have the knowledge, the intellectual capacity or moral authority to oppose or disagree with the wishes and decisions of the physician who, instead, on account of his doctrine, knows exactly what is goodfor him. In this regard, if we were to speak of consensus concerning the physician's intervention, he would be considered useless in as much as obvious and understood when seeking help. The attitude of the patient towards the physician has always tended to one of strong faith and characterized by psychological subjection borne out by traditions thousands of years old. A patient who was sick, again, as an attitude of respect and gratitude, followed the treatment but never asked for any explanations regarding the therapeutic effects and the physician refrained from taking any initiative to inform the patient or his/her family. Each phenomenon, therefore, has a precise origin, a well-defined history and when its importance tends to significantly condition the activities concerning Man, a desire emerges to learn the origin and the history. As is well known, a trial commenced in Nuremberg, on December 19, 1946, of Nazi doctors and a code was defined in which the judges, all Americans, clearly emphasized a view of medical research and technology: science should never transform or consider human beings as an instrument to be employed for scientific purposes. In actual fact, documents exist providing evidence that a few decades before the drawing up of the Nuremberg Code, the need had been expressed, in Germany itself to somehow make medical interventions and actions legal by means of the use and practice of consensus. The moral and ethical principles in those documents, even if not available as bibliographic references in the English literature, certainly merit, from a historical viewpoint to be considered as conceptual elements and doctrinal and socio-cultural products, even if at that time, of little practical importance, which belong to the European culture and, in particular, and almost paradoxically, in the light of what happened, to the German culture. The United States of America is held to be the country of origin of informed consent, the initial aim of which was make sure that the correct dignity of the patient's independence be reserved at the time of decision making and choice of medical options. Reports on this topic, in fact, first appeared in the USA, at the beginning of the 18th Century, with problems focusing on and limited to only the simple rights of the patient in giving his/her approval of the health intervention later to be conceptually developed, along the lines of an itinerary with, at intervals, famous legal actions, until in the 20th Century, informed consent was reached, a criterion that, as is well known, foresees and includes not only the important and fundamental autonomy of the patient to decide, which stems ones personal rights, but also the essential objective element, which is, information. The expression informed consent has simply been transposed in Italian and roughly translated in an ambiguous fashion into "consenso informato" when, on the contrary, it should be referred to as "informazione per il consenso" "information for consensus" not only to respect the concept but, surely, for a more correct deciphering and a more precise interpretation related to the numerous concepts it presupposes and implies. Information and consent may be compared to the two sides of the same coin. These are the two important pillars that coincide and are joined giving weight to the medical responsibility, as far as concerns consent to the health on the one hand, having obtained consent,following correct and sincere information interpreted and deciphered as an important phase and an essential indicator of correct, scrupulous medico-professional procedure and, on the other, the consensus itself conceived as a duty aiming at the maximum respect of the rights to autodetermination, independence and autonomy of the patient, as a person. At the beginning of the Nineties, as we have seen, we were made aware of a series of legal actions regarding medical responsibility which was greatly conditioned by the Anglosaxon influence which initially induced many Italian magistrates and forensic physicians to adopt an extremely rigid attitude with no attempt to comply, in any way, with the culture and traditions of our country and our tradition which has always been inspired by good common sense, both medical and human. The American experience has been very rapidly adopted, by some, without a profound, complete and necessary historical and evolutional analysis aimed at those intertwined principles that have been motifs that have gradually led to the legal references in those emblematic cases referred to, the conclusions of which continue to attract a great deal of attention. In Italy, the legal and doctrinal evolution of informed consent, even if following a little more rapidly the traces, steps, problems and interpretations of the various aspects drawn up, characterized and applied in the United States, has not only occurred at a later time, but, despite reaching the same meaningful objectives, the same considerations, the same importance, and, unfortunately, the same inconveniences, has had quite different aims, approaches and articulations. In this respect, it is enough to focus attention on the different cultural traditions and religious routes, on the different doctrinal background, the particular historical origins and the individual legal aspects, all extremely different one from the other. (ABSTRACT TRUNCATED)

Reproductive Ethics · Conscience Protections

"Chapter 1: Disturbing Trends in the Health Care of Women, Children and Families"

Hilgers TW, 2004 The Medical and Surgical Practice of NaProTECHNOLOGY

Escalating rates of contraceptive use, abortion, divorce, child abuse, teenage pregnancy, and out-of-wedlock births over the preceding four decades are documented as interconnected indicators of systemic failure in women's and family healthcare. Hilgers argues these trends reflect a prevailing medical culture that suppresses or bypasses reproductive function rather than supporting it, establishing the clinical and moral imperative for a restorative alternative.

Reproductive Ethics · Embryo Status

Chapter 60: Lethal Congenital Anomalies: Prenatal Diagnosis and the Management of Pregnancy

Hilgers TW, 2004 The Medical and Surgical Practice of NaProTECHNOLOGY

Management of pregnancies complicated by lethal fetal anomalies is addressed within an ethical framework that provides perinatal palliative care, parental support, and medical management without recourse to induced abortion. The chapter outlines clinical protocols for continuing care that respect fetal life while attending to maternal physical and psychological wellbeing through delivery and bereavement.

Reproductive Ethics · Conscience Protections

Reproductive medicine and violation of the "free exercise" clause of the United States Constitution

Hilgers TW, 2003 Linacre Q

Over the years of my involvement in obstetrics and gynecology, and reproductive medicine and surgery I have had the opportunity to see, first hand, how the religious liberties of individual physicians, medical students, nurses, patients, etc., have been violated by the contemporary trends in reproductive medicine. Since the advent of oral contraceptives, the practice of obstetrics and gynecology as it relates to procreative medicine has dramatically changed. Contraception, sterilization, abortion and in vitro fertilization are the foundation upon which reproductive medicine decision making is made. These decisions are often made with a "steam roller effect" which is completely devoid of any consent from those who are impacted by the implementation of those decisions. It has been an interesting series of events to watch over these years as the profession has become less and less diagnostically attuned and more and more "band aid" oriented. The birth control pill is used for the treatment of almost every gynecologic malady known, even though it cures none of them. Family physicians, internists, pediatricians and others tend to follow the same approach as their OB-GYN colleagues. With in vitro fertilization, instead of finding out what the underlying cause of one's infertility or reproductive problem might be, there is a "jumping over" of the underlying causes (the diseases) and a pursuit directly to a solution which first of all is very expensive, second, is not very effective and third, is considered to be highly immoral and unethical by many people in our society.

Reproductive Ethics · Embryo Status

Disposition of extra embryos

Beyler SA et al., 2000 Fertil Steril

Contemporary practice in assisted reproductive technologies (ART) compensates for the attrition that occurs at each phase of the cycle. Every follicle does not yield an egg, nor does every egg fertilize. Of those that do, many fail to properly develop, and even fewer implant. Nevertheless, ART cycles usually result in more embryos than are needed for transfer. With clinical and laboratory advances in the field and the undeniable need to reduce the incidence of multiple gestation, we must focus increased attention on these “spare” or “extra” embryos and their fate. The relative quality of extra embryos clearly influences their disposition. Although the pregnancy potential of any single embryo is always uncertain, a fragmented embryo from a patient over the age of 40 generally has less potential than a morphologically normal one from an egg donor. Data from 1996 SART registry (1) suggests that only 4% of transferred embryos from patients 39 years and older result in a child, whereas this number is approximately 12% in women under 35. Because most programs choose the highest quality embryos for transfer, potential implantation rates for spare embryos would be lower. Registry data are invaluable to track progress in the field, but they do little to guide decisions concerning individual patients, because the implantation rate of any given embryo of reasonable morphology is either zero or 100%. In the absence of more reliable markers of implantation potential, we must assume that all transferred embryos can implant. . .

Advocacy and Public Understanding · Public Awareness

Infertility is a symptom, not a disease

Dickey RP et al., 2000 Fertil Steril

In an otherwise excellent editorial that appeared in this journal concerning the problems created by failure of the Health Insurance Industry to provide coverage for infertility, the author, a noted academician and clinician, repeatedly referred to infertility as a disease (1). The mistaken idea that infertility is a disease is commonplace among not only academicians and clinicians but also among third-party payers and the general public and is one of the reasons that infertility is not covered by most insurance plans. The facts are that infertility and its frequent companion, anovulation, are not diseases; they are symptoms of underlying, sometimes serious disease in one or both marital partners. One result of considering infertility and anovulation as diseases rather than as symptoms is that unnecessarily powerful and expensive treatments may be used to obtain an immediate pregnancy, whereas chronic disease that may affect lifelong health is overlooked. Just as the symptoms chronic headache, chronic stomach pain, and chronic chest pain may be caused by underlying disease, so may infertility be caused by underlying disease. Endometriosis, uterine fibroids, benign ovarian tumors, and pelvic adhesive disease are causes of infertility that can be treated by laparoscopy, if detected early, but may require more extensive surgery later if they remain undiagnosed. Anovulation may be due to insulin resistance that can result in diabetes or cardiovascular disease later in life (2) or any of a number of other endocrine disorders with lifelong effects. A 1991 study from the Centers for Disease Control and prevention (CDC) found that the lifetime risk of developing endometrial cancer was increased not only in patients with polycystic ovary syndrome but also in infertile patients with hypothyroidism, uterine fibroids, and endometriosis (3). Infertile women with any of these conditions who conceived a term pregnancy did not have an increased risk of endometrial cancer. A major obstacle to the treatment of infertility as a symptom by the Health Insurance Industry is the way it is characterized in the International Classification of Diseases, Volume 9 (ICD). In the ICD, female infertility (Code 628.0) and male infertility (606.0) are classified as diseases but are clearly treated as symptoms. Female infertility is listed as “associated with,” “due to,” or “having its origin in” 30 other conditions. Similarly, male infertility is listed as “due to” 12 other conditions. Anovulation is given the same diagnostic code number as female infertility (628.0) and is not classified further as to its underlying causes. Health insurers have taken advantage of this to deny coverage for endocrine evaluation of patients with anovulation on the basis that it is synonymous with infertility. The ICD needs to be revised according to modern understanding of anovulation and the causes of female and male infertility, as was done in the 1999 edition for complications of pregnancy and childbirth. Health insurers must acknowledge that anovulation is a symptom separate from infertility that requires diagnosis and treatment irrespective of a desire to become pregnant. All of us, practicing physicians and academicians, should make establishment of an accurate and complete diagnosis our first goal when presented with an infertile couple.

Informed Consent · Disclosure of Risks

Postfertilization effects of oral contraceptives and their relationship to informed consent

Larimore WL et al., 2000 Arch Fam Med

The primary mechanism of oral contraceptives is to inhibit ovulation, but this mechanism is not always operative. When breakthrough ovulation occurs, then secondary mechanisms operate to prevent clinically recognized pregnancy. These secondary mechanisms may occur either before or after fertilization. Postfertilization effects would be problematic for some patients, who may desire information about this possibility. This article evaluates the available evidence for the postfertilization effects of oral contraceptives and concludes that good evidence exists to support the hypothesis that the effectiveness of oral contraceptives depends to some degree on postfertilization effects. However, there are insufficient data to quantitate the relative contribution of postfertilization effects. Despite the lack of quantitative data, the principles of informed consent suggest that patients who may object to any postfertilization loss should be made aware of this information so that they can give fully informed consent for the use of oral contraceptives.

Reproductive Ethics · Third Party Reproduction

Indecent proposal: $5,000 is not "reasonable compensation" for oocyte donors

Sauer MV, 1999 Fertil Steril

There is a growing threat to the practice of oocyte donation in the United States and all of us should take careful notice. This threat is posed by the escalating fees paid to young women for providing these services. I was shocked by the decision of St. Barnabas Medical Center in Livingston, New Jersey to double the compensation from the community standard of $2,500 to a startling $5,000 per cycle. These new fees were aggressively advertised throughout New Jersey and Manhattan in strategic periodicals, newspapers, and magazines. I was even more dismayed to see physicians and “ethicists” justifying the increase to the media (1) stating “there is nothing inherently wrong with bidding for human eggs.” For years, I have advocated compensation to oocyte donors based upon time, effort, and risk of involvement. I have addressed this topic at speaking engagements and in position papers, typically defending the belief that physicians are capable of responsible restraint (2, 3). However, I have been increasingly concerned over the encroachment upon the traditional practice by both commercial enterprises and physician-led groups who have inflated the cost of donor compensation 500% in the past decade. In most countries it is illegal to provide any compensation for oocyte donors. Many believe payment is inappropriate and many more agree that excessive compensation is ethically unacceptable, since it potentially exploits or even coerces young women to participate. Even if one considers the time spent traveling to the local office and waiting for an ultrasound exam to be “work,” donors now will be earning in excess of $300 per hour. I find it hard to believe that anyone thinks this “reasonable compensation” according to the recommendations of the Ethics Committee of the American Society for Reproductive Medicine (4). If we are truly not guilty of “pimping for patients” (5) and if donors are not “selling eggs,” then we cannot justify another doubling of the compensation. I believe this is a flagrant violation of the Ethical Considerations of Assisted Reproductive Technologies issued in 1994 (4). What is most disappointing is that this violation comes from a highly respected group led by physicians held in esteem within our subspecialty, who stated in The New York Times “I’m not sure $5,000 is enough.” (1) I would ask them, “How much is enough?” Where does this stop and at what price to our patients and our profession? Inevitably, all of us will be forced to raise our compensation rates to meet this challenge. Most importantly, and most unfortunately, these expenses will have to be passed on directly to our patients, who are already spending considerable sums of money to seek this procedure. I have always opposed government regulation and intervention, and I have often taken a public stand in defending our right to administer our own practices. However, for the first time in my career I am rethinking my position. If physicians are forced to drastically modify their practices to keep pace with commercial ventures or to compete with doctors whose modus operandi is “what the market will bear,” an approach to medicine so flagrantly greedy as to threaten the existence of the field, then I do believe it is time for regulation. These are truly sad events, and if we stand by and allow these changes to become standard operating procedure then we as professionals deserve the public criticism that will inevitably follow.

Reproductive Ethics · Third Party Reproduction

Procreation after death or mental incompetence: medical advance or technology gone awry?

Ohl DA et al., 1996 Fertil Steril

To review our experience with semen retrieval in men who are incompetent or dead and to formulate general medical, legal, and ethical guidelines for practitioners. Case series and literature review. Academic. PATIENT(S): Seven incompetent or neurologically dead individuals in whom sperm retrieval was requested. INTERVENTION(S): Electroejaculation. RESULT(S): Seminal emission was induced in the two men who underwent electroejaculation. Sperm suitable for cryopreservation was obtained in one of these men. Review of the legal and ethical implications of such procedures led to development of general guidelines for determining whether gamete retrieval should be performed when requested. Issues of procreational autonomy, consideration of the decedent's wishes, and assurance of the well-being of any new life created were considered most strongly in the formation of these guidelines. CONCLUSION(S): Although the retrieval of sperm from deceased or incompetent individuals may be achieved readily, it is incumbent upon the practitioner to consider the legal and moral implications of these procedures before proceeding.

Reproductive Ethics · Conscience Protections

Natural Family Planning and Catholic Hospitals: A National Survey

Fehring RJ et al., 1993 Linacre Q

A recent survey conducted by the American Academy of Natural Family Planning (AANFP) found that over 55% of Catholic hospitals surveyed either provide or would like to provide some form of Natural Family Planning (NFP) services. In addition, over 60% of the respondents felt that NFP should be part of the mission of a Catholic hospital.

Policy and Regulation · Professional Standards

Family planning. Objectives, measures, regulations, structures

Meyer L, 1991 Rev Prat

5 major criteria are used to evaluate family planning efficacy, both theoretical and practical; acceptability as measured by continuation of use; safety; reversibility; and cost, including the cost of treatment, follow-up, and screening for contraindications. Traditional family planning methods are mostly based on periodic abstinence during the presumed fertile period. The calendar, temperature, Billings or cervical mucus, and symptothermal methods are based on observation of different symptoms of ovulation and fertility. Their advantages are that they do not require intervention by health personnel, their costs of use are nil, and they are morally acceptable to some couples. Their efficacy is lower than that of other methods and they should be viewed as methods to space rather than limit births. The withdrawal method, also less effective, requires active cooperation by the male partner. Among mechanical methods, the use of condoms has increased recently because of the protection they offer against HIV infection and other sexually transmitted diseases. Their efficacy depends on correct use, regular use, and the quality of the condom. The Pearl index varies from 93099 per 100 woman-years. The diaphragm must be individually measured and should be used with spermicides. The Pearl index ranges from 85095 per 100 woman-years. Spermicides, generally either nonoxynol-9 or benzalkonium chloride, are surfactants that have a Pearl index of 83-97 per 100 woman-years. They are available as creams, jellies, foams, suppositories, tablets, or impregnated sponges. Most failures appear due to errors of utilization. The mechanism of action of the IUD is imperfectly understood, but it is known to prevent nidation of the fertilized egg. Copper devised have higher rates of efficacy and tolerance. Pearl indices range from 95-99.5. Contraindications include genital infection, uterine anomalies, valvular cardiopathy, and coagulation problems. The IUD is relatively contraindicated if there is history of ectopic pregnancy or upper genital tract infections. The combined oral contraceptive is the most widely utilized method in France. The Pearl index is nearly 100 in the absence of forgetting, vomiting, or drug interactions. The contraindications are basically those of estrogens: history of thrombosis, prolonged bedrest, hypertension, hyperlipidemia, hepatic disorders, hormonodependent cancers, or smoking after age 35. Progestin-only methods are available in 3 forms: low-dose pills which must be taken at the same time each day, higher-dosed progestins taken for 20 days each month, and injectable progestins providing contraception for 8-12 weeks. Postcoital contraception using OCs or IUDs is possible but not well known among women or physicians. The Neuwirth law authorizing use of contraception in France was passed in 1967. Amendments in 1974 improved access and provided for reimbursement for some methods, but some newer forms are not reimbursed.

Policy and Regulation · Professional Standards

Human Fertilisation and Embryology Act 1990

United Kingdom Parliament, 1990

An Act to make provision in connection with human embryos and any subsequent development of such embryos; to prohibit certain practices in connection with embryos and gametes; to establish a Human Fertilisation and Embryology Authority; to make provision about the persons who in certain circumstances are to be treated in law as the parents of a child; and to amend the Surrogacy Arrangements Act 1985. The 1990 Act established the HFEA as the UK's statutory regulator of fertility treatment and human embryo research. It introduced licensing requirements for any clinic offering in vitro fertilisation, donor insemination, embryo storage, or human embryo research. The Act created criminal offences for unlicensed activity and prohibited certain practices including placing a non-human embryo in a woman, keeping or using an embryo after the appearance of the primitive streak (interpreted as 14 days post-fertilisation), and replacing an embryo's nucleus. The HFEA was empowered to keep a register of identifying information about donors, recipients, and people born from licensed treatments, and to issue a Code of Practice. Sections 13 and 14 set out treatment licence conditions including welfare-of-the-child considerations and consent requirements.

Reproductive Ethics · Third Party Reproduction

The single woman and artificial insemination by donor

Strong C et al., 1984 J Reprod Med

Requests by single women for artificial insemination by donor (AID) raise important ethical issues concerning the obligations of physicians and the well-being of the children who would be conceived. Specific objections to AID for single women can be raised, including that the absence of a father may adversely affect the child or that a lesbian mother may influence the child to become homosexual. A review of the relevant social science research indicates, however, that these and other objections are not supported by the available data. In support of AID for single women it can be argued that the life of the child who would be produced could be expected to have value, considered in itself. Consideration of the various aspects of the issue suggests that AID for single women is permissible in selected cases and that the physician has a right to refuse to carry out such requests.

Also filed here

Diagnostic Criteria and Classification · Terminology and Definitions

Polyendocrine metabolic ovarian syndrome, the new name for polycystic ovary syndrome: a multistep global consensus process

Teede HJ et al., 2026 Lancet (London, England) Open Access

Polyendocrine metabolic ovarian syndrome (PMOS), previously named polycystic ovary syndrome (PCOS), affects one in eight women. However, the term PCOS is inaccurate, implying pathological ovarian cysts, obscuring diverse endocrine and metabolic features, and contributing to delayed diagnosis, fragmented care, and stigma, while curtailing research and policy framing. Building on an international mandate for change, we outline an unprecedented, rigorous, multistep global consensus process for the name change. Funding and governance were established with engagement of 56 leading academic, clinical, and patient organisations. Using iterative global surveys (with responses from 14 360 people with PCOS and multidisciplinary health professionals from all world regions), modified Delphi methods, nominal group technique workshops, and marketing and implementation analyses, we identified principles prioritising scientific accuracy, clarity, stigma avoidance, cultural appropriateness, and implementation feasibility. An accurate new name was prioritised over retaining the PCOS acronym or a generic name. Implementation approaches prioritised evolution rather than transformation. Preferred terms were polyendocrine, metabolic, and ovarian, reflecting the condition's multisystem pathophysiology, and polyendocrine metabolic ovarian syndrome was the consensus new name. Accuracy was improved by omitting cysts and by capturing endocrine, metabolic, and ovarian dysfunction. A co-designed global implementation strategy, including a transition period, education, and alignment with health systems and disease classification, is under way.

Registries and Reporting · National Registry Data

The Fertility Sector 2024/25

Human Fertilisation and Embryology Authority, 2025

# The fertility sector 2024/25 Annual publication on HFEA licensed clinics (1 April 2024 – 31 March 2025) Published: November 2025 [Download the underlying dataset as Excel Worksheet](https://www.hfea.gov.uk/media/cpzhqp1p/the-fertility-sector-2024-25-underlying-dataset.xlsx "The fertility sector 2024/25 - underlying dataset") ## Table of contents - [1\. How we regulate](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#how-we-regulate) - [2\. Main points](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#main-points) - [3\. How the HFEA inspects clinics](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#how-the-hfea-inspects-clinics) - [4\. Inspections](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#inspections) - [5\. Non-compliances identified at inspections](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#non-compliances-identified-at-inspections) - [6\. Clinic licences](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#clinic-licences) - [7\. Incidents](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#incidents) - [8\. Ovarian Hyperstimulation Syndrome (OHSS)](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#ovarian-hyperstimulation-syndrome-ohss) - [9\. Patient complaints](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#patient-complaints) - [10\. Patient feedback](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#patient-feedback) - [11\. About our data](https://www.hfea.gov.uk/about-us/publications/research-and-data/the-fertility-sector-2024-2025/#about-our-data) ## 1\. How we regulate The Human Fe...

History of the Discipline · Origins of Restorative Practice

Understanding Restorative Reproductive Medicine

Boyle P, 2025 J Restorative Reprod Med Open Access

Recently, editorials have been published in reproductive medical journals that have misunderstood and misrepresented the origin and meaning of “restorative reproductive medicine” (RRM).1,2 This term was first used in 2000 when a group of physicians established the International Institute for Restorative Reproductive Medicine (IIRRM, iirrm.org ). I am a founding member and am currently president of the IIRRM. The IIRRM was founded as a secular, not a faith-based organization. We adhere to time-honoured medical principles to understand and treat underlying factors responsible for infertility. We are always seeking to improve our diagnosis and treatment of those factors, the training of clinicians who offer RRM, and the quality of clinical practice of RRM. We believe that in the clinical realm, in vitro fertilization (IVF) is often offered quickly without sufficient efforts first made to help couples conceive naturally. IVF was originally developed to treat patients with bilateral tubal occlusion who could not conceive through sexual intercourse. Most patients who undergo IVF today do not have blocked fallopian tubes. Intracytoplasmic Sperm Injection (ICSI) was developed for patients with severe male factor infertility. Most patients who undergo ICSI today do not have severe male factor infertility. Remarkably, the most recent Cochrane review of IVF indicates ongoing uncertainty about whether IVF improves the live birth rate compared to expectant management for previously untreated couples with “unexplained” subfertility.3 I am an active RRM clinician since 1998 and I have treated thousands of couples. When patients present for fertility treatment, I do not ask them what religion, political view, or philosophy they support, because that is irrelevant to people who want a solution for their infertility. If they have a condition that is better treated by IVF, I tell them that at the first appointment. If natural conception is possible with RRM, I explain what is involved and outline the treatment process which can take up to 12 cycles (most often less) to reach a healthy ongoing pregnancy, or a full course of treatment. RRM honours patient autonomy. We do not seek to prohibit patient access to IVF. Patients seek us out. RRM expands their choices and options. Many of my patients were previously seen in fertility clinics that offer IVF. Patients repeatedly tell me they did not receive the same depth of investigation or non-IVF treatment in the IVF clinics. I recently received these comments from patients, “RRM empowered us in our fertility journey. It provided a personalised approach. We are so grateful.” And “even if we didn’t conceive, we’d never regret trying RRM as my health improved immeasurably…” The World Health Organization states that “Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse”.4 As RRM physicians, we respectfully suggest a slight but essential alteration: “Infertility is a medical condition defined by failure to achieve a pregnancy after 12 months or more of regular sexual intercourse without contraception, which is caused by one or more underlying diseases and conditions involving the male or female reproductive system.” This definition indicates that infertility is not a singular condition to be treated solely by treatments to generate a pregnancy and birth. Rather, it is “a canary in the coal mine” for human health, indicating the need to identify and address underlying health concerns. 5,6 As RRM physicians and clinicians we have training and backgrounds that allow us to treat infertility patients with a focus on treatments and approaches that restore and optimize natural function. The specialty of reproductive endocrinology and infertility has extensive training with a particular focus on IVF and treatments to improve the success of IVF. But we can and should be in agreement to offer patients evidence-based information and treatments that meet the needs and preferences of patients. Further research is needed and is currently ongoing on patient-relevant questions, such as: How does an RRM evaluation differ in process and results from a fertility evaluation before initiating IVF? How do the outcomes of RRM and IVF compare on multiple levels including live birth rates, premature delivery, patient satisfaction, health improvement, and repeat successful births?7 For the sake of our patients with infertility, let us strive to be objective about the scientific facts, and meet all patients with respect. Surely as we challenge and learn from one another and strive for excellence, the patients will be the ultimate beneficiaries.

Add-Ons and Adjuncts · Preimplantation Genetic Testing

Promises and pitfalls of preimplantation genetic testing for polygenic disorders: a narrative review

Roura-Monllor JA et al., 2025 F S Rev

Preimplantation genetic testing for polygenic disorders (PGT-P) has been commercially available since 2019. PGT-P makes use of polygenic risk scores for conditions which are multifactorial and are significantly influenced by environmental and lifestyle factors. If current predictions are accurate, then absolute risk reductions range from about 0.02% to 10.1%, meaning that between 10 and 5,000 in vitro fertilization patients would need to be tested with PGT-P to prevent one offspring from becoming affected in the future, depending on the condition and the number of embryos available. Survey and interview data reveal that patients and the public have largely favorable views regarding the use of PGT-P for disease prevention; however, clinicians and professional organizations have many reservations. The use of PGT-P raises multiple social and ethical concerns including the need for adequate counseling, the setting of realistic expectations, the application of distributive justice, the impact of environmental and social determinants of health, and the potential exacerbation of health inequities. Clinicians expressed significant concerns relating to the cost of PGT-P, the potential time-consuming counseling for reproductive endocrinologists and genetic counselors, the intentional creation of supernumerary embryos, and patients' unrealistic expectations regarding "healthiest disease-free" embryos. Furthermore, current evidence lacks long-term outcome data and generalizability. Prior to offering PGT-P to patients, additional clinical validation studies are needed. Also, ethical and social considerations raised by PGT-P should be carefully delineated. Systemic practices to increase equitable access to unbiased genetic counseling and reproductive services would be desirable prior to the ethical implementation of PGT-P.

Guidelines by Issuing Body · Specialty and Consensus Panels

RTAC Code of Practice for Reproductive Technology Units (Australia and New Zealand) - December 2024 (Issue 9)

Reproductive Technology Accreditation Committee et al., 2024 Fertility Society of Australia and New Zealand - RTAC

RTAC Code of Practice (Issue 9) governing accreditation requirements for reproductive technology units operating in Australia and New Zealand. Sets standards for clinical, laboratory, and quality-management practices that ART centres must meet to remain RTAC-accredited and eligible to submit cycles to ANZARD. Includes patient safety, embryology laboratory, donor-program, and incident-reporting requirements. Effective from December 2024.

Registries and Reporting · National Registry Data

State of the Fertility Sector 2023/2024

Human Fertilisation and Embryology Authority, 2024

# State of the fertility sector 2023/24 Annual publication on HFEA licensed clinics (1st April 2023 – 31st March 2024) Published: 1st October 2024 [Download the underlying dataset as .xlsx](https://www.hfea.gov.uk/media/cjwjns5j/state-of-the-fertility-sector-2023-2024-underlying-dataset.xlsx "State of the fertility sector 2023-2024 - underlying dataset") ## Table of contents - [How we regulate](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#how-we-regulate) - [1\. Inspections in 2023/24](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#section-1) - [2\. There were 226 non-compliances identified at inspection in 2023/24](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#section-2) - [3\. In 2023/24, 135 clinics were licensed by the HFEA to provide fertility treatment, storage and/or research](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#section-3) - [4\. Total incidents reduced by 8% compared to the previous financial year](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#section-4) - [5\. Fewer Ovarian hyperstimulation syndrome (OHSS) incidents were reported in 2023/24](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#section-5) - [6\. Patient complaints in 2023/24 were consistent with the previous financial year](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#section-6) - [About our data](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2023-2024/#about-our-data) ## How we regulate The Human Fertilisation and Embryology Authority (HFEA) is the independent regulator of fertility treatment and human embryo research in the United Ki...

Registries and Reporting · National Registry Data

State of the Fertility Sector 2022/2023

Human Fertilisation and Embryology Authority, 2023

# State of the fertility sector 2022/23 Annual publication on HFEA licensed centres (1st April 2022 – 31st March 2023) Published: 12th September 2023 [Download the underlying dataset as .xlsx](https://www.hfea.gov.uk/media/2znoxhqv/state-of-the-fertility-sector-2022-2023-underlying-dataset.xlsx "State of the fertility sector 2022-2023 - underlying dataset") ## Table of contents - [About this report](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#about-this-report) - [1\. There were 85 inspections undertaken in 2022/23](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#section-1) - [2\. Critical non-compliances have decreased to 2%](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#section-2) - [3\. In 2022/23, 107 clinics were licensed by the HFEA to provide fertility treatment](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#section-3) - [4\. No Grade A incidents since 2020/21, and severe/critical OHSS incidents remained consistent with previous years](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#section-4) - [5\. Patient complaints decreased in 2022/23](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#section-5) - [About our data](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2022-2023/#about-our-data) ## About this report The Human Fertilisation and Embryology Authority (HFEA) is the independent regulator of fertility treatment and human embryo research in the United Kingdom (UK). We aim to ensure that everyone receives high quality care in a licenced fertility clinic. We do this by licensing, monitoring, and inspecting fertility clinics and research centres [i](https://www.hfea.go...

Pelvic Pain · Chronic Pelvic Pain

Exploring the lived experiences of debilitating period pain management in the UK

Vafapour P et al., 2023 Br J Pain Open Access

Five to ten percent of women experience period pains that disrupt their lives yet 4 in 5 women believe that their claims for their dysmenorrhea are not taken seriously. Within the process of seeking support and understanding about their pain, they face various barriers that prevent them from finding the answers they deserve. Semi-structured interviews were conducted with 8 women aged 20-28 to discuss their experiences with dysmenorrhea throughout their time since menarche. Using Scheper-Hughes and Lock understanding of the mindful body, this research explores women's experiences of dysmenorrhea through their physical body (relationship with the body and needing control), the social body (cultural concepts and comparisons to others) and the body politic (medicalisation, the medical team and the transvaginal ultrasound). The impact of these aspects of their mindful bodies developed arguments showing how different actors had an impact on preventing them obtaining the patient-centred care they required without resistance. More must be done to honour the experience of pain women have regarding their periods, especially by healthcare professionals. There must be consistency in the way women are approached for their dysmenorrhea to prevent discrepancies of support. This must be done with clearer guidance on what is offered to women with dysmenorrhea, especially in the primary care setting.

Registries and Reporting · National Registry Data

State of the Fertility Sector 2021/2022

Human Fertilisation and Embryology Authority, 2022

# State of the fertility sector 2021/22 Annual publication on HFEA licensed clinics Published: October 2022 [Download the underlying dataset as .xlsx](https://www.hfea.gov.uk/media/lxkhzo04/state-of-the-fertility-sector-2021-2022-underlying-data.xlsx "State of the Fertility Sector 2021 - 2022 - underlying data") ## Table of contents - [About this report](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#section-1) - [1\. Changes to interim inspection themes](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#section-2) - [2\. There were 105 inspections undertaken in 2021/22](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#section-3) - [3\. In 2021/22, 104 clinics were licensed by the HFEA to provide fertility treatment](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#section-4) - [4\. No Grade A incidents since 2020/21, and severe OHSS remained consistent with previous years](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#section-5) - [5\. Patient complaints decreased in 2021/22](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#section-6) - [About our data](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2021-2022/#about-our-data) ## About this report The Human Fertilisation and Embryology Authority (HFEA) is the independent regulator of fertility treatment and human embryo research in the United Kingdom (UK). We aim to ensure that everyone receives high quality care in a licenced fertility clinic. We do this by licensing, monitoring, and inspecting fertility clinics and providing free, clear and impartial information about fertility treatment, clinics, and egg, sperm, and embryo donation. ...

Birth Outcomes · Maternal Morbidity

Patient-centered perinatal palliative care: family birth plans, outcomes, and resource utilization in a diverse cohort

Buskmiller C et al., 2022 Am J Obstet Gynecol MFM

Perinatal palliative care is an emerging concept in fetal medicine that offers quality-of-life options and anticipatory grief management for families of fetuses with complex conditions. Few perinatal palliative care outcomes are detailed in peer-reviewed literature. This study aimed to describe outcomes of perinatal palliative care at the Fetal Center of the University of Texas Health Science Center at Houston and Women's Center at Children's Memorial Hermann Hospital. This was a retrospective cohort of families receiving perinatal palliative care for life-limiting fetal diagnosis, such as trisomy 13 or 18 and some major structural anomalies between 2016 and 2020. The primary outcome was whether delivery events matched families' birth plans, including fetal/neonatal clinical course matching expectations described by consultant notes. Secondary outcomes included maternal safety outcomes, use of perinatal interventions, delivery outcomes, and resource utilization outcomes. Of 187 perinatal palliative care consults, delivery events matched families' plans and clinicians' expectations in 89% of cases (165/185); 39% (73/187) of families requested some perinatal interventions, 64% of whom planned postnatal comfort care even while choosing antenatal interventions. Demographics and median income were similar between families who chose some interventions and those who chose comfort care. Patients choosing any interventions had more mismatches between their plans and delivery events (19% vs 2%; P<.001), were more likely to change their plans (24% vs 6%; P=.001), and unsurprisingly used more healthcare resources. They were also more likely to have intraamniotic infection or postpartum hemorrhage (9% vs 22%; P=.02), but this was associated with mode of delivery and not choice of interventions. Most families' perinatal experiences matched birth plans and expectations in this perinatal palliative care program. Families who desired interventions used more healthcare resources, but often did so with plans for postnatal comfort care, demonstrating insight into neonatal prognosis but achieving value-consistent goals, such as meeting a live neonate. Perinatal palliative care was safe for maternal patients and equitable across racial, ethnic, and income groups. Perinatal palliative care and some perinatal interventions are options for care of the whole family in complex fetal medicine cases.

Use and Experience · Method Teaching

Natural Family Planning, An Option in Reproductive Healthcare: A Qualitative Study on Clinicians' Perceptions

Joan Ibeziako O, 2022 Linacre Q

Natural family planning (NFP) empowers women to control their reproductive health and approach fertility as a normal biological process. Although substantive literature supports their comparative effectiveness with contraceptive methods, there is a paucity of this knowledge amongst clinicians and users. This study aimed to understand clinicians' perceptions regarding offering NFP to patients as part of reproductive health care. It explored clinicians' knowledge of NFP, described their perceptions of their effectiveness, and identified enabling and deterring factors to their use. Basic Interpretive qualitative research design was appropriate in obtaining an in-depth description of this phenomenon. It was conducted in 2018 in two hospitals and clinics in Ekurhuleni health district, located East of Gauteng Province, South Africa. Fifteen doctors and nurses from diverse cultural and educational backgrounds were purposefully selected and interviewed. Transcribed data were analyzed, coded, and recurrent themes identified. Training that empowers clinicians on NFP methods and their effectiveness will improve their willingness to advocate for it and promote patient autonomy by providing comprehensive counseling on family planning methods. Further, a pro-NFP policy would drive training in undergraduate and postgraduate programs and increase public awareness, including early education of male and female children.

Guidelines by Clinical Area · Obstetric Guidelines

Society for Maternal-Fetal Medicine Consult Series #60: Management of pregnancies resulting from in vitro fertilization

Society for Maternal-Fetal Medicine et al., 2022 American Journal of Obstetrics and Gynecology Open Access

The use of assisted reproductive technology has increased in the United States in the past several decades. Although most of these pregnancies are uncomplicated, in vitro fertilization is associated with an increased risk for adverse perinatal outcomes primarily caused by the increased risks of prematurity and low birthweight associated with in vitro fertilization pregnancies. This Consult discusses the management of pregnancies achieved with in vitro fertilization and provides recommendations based on the available evidence. The recommendations by the Society for Maternal-Fetal Medicine are as follows: (1) we suggest that genetic counseling be offered to all patients undergoing or who have undergone in vitro fertilization with or without intracytoplasmic sperm injection (GRADE 2C); (2) regardless of whether preimplantation genetic testing has been performed, we recommend that all patients who have achieved pregnancy with in vitro fertilization be offered the options of prenatal genetic screening and diagnostic testing via chorionic villus sampling or amniocentesis (GRADE 1C); (3) we recommend that the accuracy of first-trimester screening tests, including cell-free DNA for aneuploidy, be discussed with patients undergoing or who have undergone in vitro fertilization (GRADE 1A); (4) when multifetal pregnancies do occur, we recommend that counseling be offered regarding the option of multifetal pregnancy reduction (GRADE 1C); (5) we recommend that a detailed obstetrical ultrasound examination (CPT 76811) be performed for pregnancies achieved with in vitro fertilization and intracytoplasmic sperm injection (GRADE 1B); (6) we suggest that fetal echocardiography be offered to patients with pregnancies achieved with in vitro fertilization and intracytoplasmic sperm injection (GRADE 2C); (7) we recommend that a careful examination of the placental location, placental shape, and cord insertion site be performed at the time of the detailed fetal anatomy ultrasound, including evaluation for vasa previa (GRADE 1B); (8) although visualization of the cervix at the 18 0/7 to 22 6/7 weeks of gestation anatomy assessment with either a transabdominal or endovaginal approach is recommended, we do not recommend serial cervical length assessment as a routine practice for pregnancies achieved with in vitro fertilization (GRADE 1C); (9) we suggest that an assessment of fetal growth be performed in the third trimester for pregnancies achieved with in vitro fertilization; however, serial growth ultrasounds are not recommended for the sole indication of in vitro fertilization (GRADE 2B); (10) we do not recommend low-dose aspirin for patients with pregnancies achieved with IVF as the sole indication for preeclampsia prophylaxis; however, if 1 or more additional risk factors are present, low-dose aspirin is recommended (GRADE 1B); (11) given the increased risk for stillbirth, we suggest weekly antenatal fetal surveillance beginning by 36 0/7 weeks of gestation for pregnancies achieved with in vitro fertilization (GRADE 2C); (12) in the absence of studies focused specifically on timing of delivery for pregnancies achieved with IVF, we recommend shared decision-making between patients and healthcare providers when considering induction of labor at 39 weeks of gestation (GRADE 1C).

Restorative Care and Assisted Reproduction · Outcome Comparisons

How NaProTechnology compares with assisted reproductive technology

Gallo P et al., 2022 mye Open Access

La progresiva medicalización de la infertilidad en las últimas tres décadas se corresponde con una creciente difusión de las Tecnologías de Reproducción Asistida (TRA), que han dejado en la sombra, casi por completo, otros enfoques más fisiológicos del tratamiento de la infertilidad, que tienen menos riesgos, son más económicos y, a la vez, igualmente efectivos. Este trabajo presenta un enfoque sistemático e integrado: la NaProTecnología (NPT), que tiene como objetivo optimizar las condiciones fisiológicas en cada ciclo menstrual, para permitir, de esta forma, una concepción por métodos naturales. Este método se postula como una mejor solución para el tratamiento de la infertilidad, desde un punto de vista que no sólo es más ético, sino que, además, es compatible con otros puntos de vistas religiosos, médicos, sociales, legales y ambientales. Los gobiernos deberían promover y financiar la NPT y, al mismo tiempo, las sociedades médicas y científicas deberían diseñar estudios para comparar de una manera justa la tasa de éxito, los costos y las complicaciones de la NPT en contraposición al método TRA tradicional.

Registries and Reporting · National Registry Data

Rapport annuel d'AMP Vigilance 2021

Agence de la biomédecine, 2022 Agence de la biomédecine

Rapport annuel d'AMP Vigilance 2021 publié par l'Agence de la biomédecine. Annual AMP (Medically Assisted Reproduction) Vigilance Report 2021 from the French Agence de la biomédecine.

Grief and Loss · Stillbirth and Infant Loss

A Scoping Review of Perinatal Palliative Care: Allowing Parents to Be Parents

Buskmiller C et al., 2021 Am J Perinatol

Perinatal palliative care (PPC) is an option for patients who discover that their infant has a life-limiting fetal condition, which decreases the burden of the condition using a multidisciplinary approach. This review discusses the landmark literature in the past two decades, which have seen significant growth and development in the concept of PPC. The literature describes the background, quality, and benefits of offering PPC, as well as the ethical principles that support its being offered in every discussion of fetal life-limiting diagnoses. PPC shares a similar risk profile to other options after life-limiting diagnosis, including satisfaction with choice of continuation of pregnancy. The present clinical opinion closes by noting common barriers to establishing PPC programs and offers a response to overcome each one. · Perinatal palliative care serves patients who continue pregnancies with life-limiting fetal anomaly.. · Perinatal palliative care has a risk profile similar to other options such as termination.. · Health care providers can serve as champions to extend PPC to patients in their region..

Prescribing Safety · Medication Safety in Pregnancy

Paracetamol use during pregnancy - a call for precautionary action

Bauer AZ et al., 2021 Nature reviews. Endocrinology

Paracetamol (N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen) is the active ingredient in more than 600 medications used to relieve mild to moderate pain and reduce fever. APAP is widely used by pregnant women as governmental agencies, including the FDA and EMA, have long considered APAP appropriate for use during pregnancy when used as directed. However, increasing experimental and epidemiological research suggests that prenatal exposure to APAP might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders. Here we summarize this evidence and call for precautionary action through a focused research effort and by increasing awareness among health professionals and pregnant women. APAP is an important medication and alternatives for treatment of high fever and severe pain are limited. We recommend that pregnant women should be cautioned at the beginning of pregnancy to: forego APAP unless its use is medically indicated; consult with a physician or pharmacist if they are uncertain whether use is indicated and before using on a long-term basis; and minimize exposure by using the lowest effective dose for the shortest possible time. We suggest specific actions to implement these recommendations. This Consensus Statement reflects our concerns and is currently supported by 91 scientists, clinicians and public health professionals from across the globe.

Registries and Reporting · National Registry Data

State of the Fertility Sector 2020/2021

Human Fertilisation and Embryology Authority, 2021

# State of the fertility sector 2020/21 **Annual publication on HFEA licensed clinics** Published: November 2021 [**Download the underlying dataset as .xlsx**](https://www.hfea.gov.uk/media/5czb4k2o/2024-02-26-state-of-the-sector-underlying-data.xlsx "State of the Sector 2020/21 underlying dataset"). ## Table of contents - [About this report](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#about-this-report) - [HFEA regulatory response to COVID-19](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#hfea-regulatory-response-to-covid-19) - [Maintaining regulatory oversight](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#maintaining-regulatory-oversight) - [There were 77 inspections undertaken in 2020/21, taking a hybrid inspection approach](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#there-were-77-inspections-undertaken-in-2020-21-taking-a-hybrid-inspection-approach) - [In 2020/21, 103 clinics were licensed by the HFEA to provide fertility treatment](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#in-2020-21-103-clinics-were-licensed-by-the-hfea-to-provide-fertility-treatment) - [The number of incidents in 2020/21 is broadly consistent with previous years](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#the-number-of-incidents-in-2020-21-is-broadly-consistent-with-previous-years) - [The number of severe incidents of OHSS reported declined in 2020/21](https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2020-2021/#the-number-of-severe-incidents-of-ohss-reported-declined-in-2020-21) - [A total of 88 patient complaints were received about licensed clinics in 2...

Hormonal Agents · Androgens and DHEA

Testosterone Therapy in Women: A Clinical Challenge

Dunsmoor-Su R et al., 2021 Obstetrics and gynecology

The physiology of testosterone as a normal female hormone in reproductive years and beyond is poorly taught and understood. This has led to unregulated and dangerous prescribing practices by physicians and other health care professionals. There are data for safe use, and as women's health care practitioners, we owe it to our patients to follow these guidelines and practices, as well as advocate for more research and safer, regulated products to prescribe.

Guidelines by Issuing Body · United States Professional Societies

Screening for autosomal recessive and X-linked conditions during pregnancy and preconception: a practice resource of the American College of Medical Genetics and Genomics (ACMG)

Gregg AR et al., 2021 Genet Med

Carrier screening began 50 years ago with screening for conditions that have a high prevalence in defined racial/ethnic groups (e.g., Tay-Sachs disease in the Ashkenazi Jewish population; sickle cell disease in Black individuals). Cystic fibrosis was the first medical condition for which panethnic screening was recommended, followed by spinal muscular atrophy. Next-generation sequencing allows low cost and high throughput identification of sequence variants across many genes simultaneously. Since the phrase "expanded carrier screening" is nonspecific, there is a need to define carrier screening processes in a way that will allow equitable opportunity for patients to learn their reproductive risks using next-generation sequencing technology. An improved understanding of this risk allows patients to make informed reproductive decisions. Reproductive decision making is the established metric for clinical utility of population-based carrier screening. Furthermore, standardization of the screening approach will facilitate testing consistency. This practice resource reviews the current status of carrier screening, provides answers to some of the emerging questions, and recommends a consistent and equitable approach for offering carrier screening to all individuals during pregnancy or preconception.

Access and Coverage · Insurance Coverage

Disparities in access to effective treatment for infertility in the United States: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2021 Fertility and sterility

In the United States, economic, racial, ethnic, geographic, and other disparities prevent access to fertility treatment and affect treatment outcomes. This opinion examines the factors that contribute to these disparities, proposes actions to address them, and replaces the document of the same name, last published in 2015.

Evidence Synthesis · Systematic Reviews

Problems with Using Polygenic Scores to Select Embryos

Turley P et al., 2021 N Engl J Med

Companies have recently begun to sell a new service to patients considering in vitro fertilization: embryo selection based on polygenic scores (ESPS). These scores represent individualized predictions of health and other outcomes derived from genomewide association studies in adults to partially predict these outcomes. This article includes a discussion of many factors that lower the predictive power of polygenic scores in the context of embryo selection and quantifies these effects for a variety of clinical and nonclinical traits. Also discussed are potential unintended consequences of ESPS (including selecting for adverse traits, altering population demographics, exacerbating inequalities in society, and devaluing certain traits). Recommendations for the responsible communication about ESPS by practitioners are provided, and a call for a society-wide conversation about this technology is made. (Funded by the National Institute on Aging and others.).

Guidelines by Clinical Area · Fertility and Infertility Guidelines

Minimum standards for practices offering assisted reproductive technologies: a committee opinion

Practice Committee of the American Society for Reproductive Medicine et al., 2021 Fertility and sterility

This document is designed to provide a framework for assisted reproductive technology (ART) programs that meet or exceed the requirements suggested by the Centers for Disease Control and Prevention for certification of ART laboratories. This document replaces the document "Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies: A Committee Opinion" published in 2019.

Infertility Distress · Treatment Burden and Burnout

Marital Satisfaction of Infertile Couples Using Natural Procreative Technology (NaProTECHNOLOGY)

Konicki AJ et al., 2020 J Christ Nurs

Infertility affects one in 16 married women in the United States where 12.7% of these seek treatment. The stress of infertility and treatment is known to impact marital satisfaction, which can be further complicated by personal and religious beliefs regarding the ethics of some assistive reproductive technologies. A morally acceptable approach to infertility diagnosis and treatment is natural procreative technology or NaProTECHNOLOGY (NPT) using the Creighton Model FertilityCare™ System. A quantitative, descriptive study utilizing demographic surveys and the Index of Marital Satisfaction found that couples using NPT reported marital satisfaction.

Access and Coverage · Workforce and Availability

Is ART utilization the best indicator of access to fertility care?

Stanford JB et al., 2020 Reprod Biomed Online

While we agree with many of the points stated by Dyer et al. in their recent commentary inRBMO(Dyer et al., 2020), we believe their conclusions are focused too narrowly. Limiting the indicator of access to, and utilization of, fertility treatment to assisted reproductive technology (ART) excludes information that is of key importance for subfertile couples, populations, and policymakers. Even in countries where access to ART is widespread, there are more births in subfertile couples through non-ART treatment than through ART (Stanford et al., 2016). While ART is necessary for some couples to have a child, it is not required for many subfertile couples, and overuse of ART may potentially be harmful (Annual Capri Workshop Group 2019). Focusing solely on ART as a metric may unnecessarily encourage overutilization (Boltz et al., 2017). We believe the focus on ART and its outcomes for national and international registries of fertility treatment has stunted the scientific development of non-ART treatments, including those which seek to address underlying health conditions (Boyle et al., 2018). There is a pressing and critical need to develop robust registries of couples treated with non-ART treatments, for the improvement of outcomes and the promotion of robust consumer choice. (Spandorfer, 2020). The ultimate measure of access to fertility care should be determined by the proportion of those with a desire for fertility who achieve a healthy live birth, whether or not ART is required to do so (Mascarenhas et al., 2012). Therefore, notwithstanding methodologic challenges, registry assessments should be developed and supported for all fertility treatments, not only ART.

Registries and Reporting · National Registry Data

State of the Fertility Sector 2019/2020

Human Fertilisation and Embryology Authority, 2020

# State of the fertility sector 2019/2020 **Annual publication on our regulatory work** Published: November 2020 [**Download the underlying data set as.xlsx (47KB)**](https://www.hfea.gov.uk/media/3289/state-of-the-sector-2019-20-underlying-data.xlsx) * * * ### About this report We are the independent regulator of fertility treatment and human embryo research in the United Kingdom (UK). We aim to ensure that everyone who steps into a fertility clinic, and everyone born as a result of treatment, receives high quality care. We do this by licensing, monitoring and inspecting fertility clinics and providing free, clear and impartial information about fertility treatment, clinics, and egg, sperm and embryo donation. State of the Sector is our annual report, which summarises what we have seen through our regulatory work during the year. The report is compiled from information gathered from our inspections throughout the year and uses other sources of information including our Register of fertility treatments, incident reports and patient feedback mechanisms. In 2019/20, we introduced a [**Clinical Governance Quarterly Update**](https://portal.hfea.gov.uk/knowledge-base/clinic-focus/) which provides clinics with detailed insight into non-compliances in a more timely manner to help clinics improve compliance and prepare for inspections. As a result, the State of the Sector report this year provides a high-level overview of sector-wide compliance, reporting on the absolute number of inspections, non-compliances, incidents and complaints. * * * ### Impact of COVID-19 on the fertility sector This report looks at the financial year 2019/20 (1 April 2019 – 31 March 2020), predominantly covering the period before any COVID-19 restrictions were put in place. As COVID-19 caused unprecedented demand on the NHS during the initial wave of the pandemic, the Human Fertilisation and Embryology Authority (HFEA) made the difficult decision to publish [**General Direction 0014**](https://po...

Age and Fertility · Female Age and Fecundability

Knowledge about the impact of age on fertility: a brief review

Delbaere I et al., 2020 Ups J Med Sci Open Access

Delayed childbearing is currently a major challenge in reproductive medicine as increased age has an important impact on successful conception, both in natural and in assisted reproduction. There is a lack of knowledge about the impact of age on fertility, even in highly educated populations. A number of initiatives have been taken to increase fertility awareness. Health care providers have been encouraged to talk with patients about their reproductive life plan (RLP) for almost a decade based on recommendations from the Centres for Disease Control and Prevention. This concept has been explored successfully in Swedish contraception counselling. A growing number of online interventions aim to raise fertility awareness. These websites or interactive tools provide relevant information for individuals and couples as they consider whether they want children, when they should have them, and how many they may wish to have. These interventions are important, because research depicts that knowledge helps people in their decision-making process. With new fertility preservations such as egg freezing now available, additional education is needed to be sure that women and couples are well informed about the cost and low success rates of this intervention.

Guidelines by Clinical Area · Obstetric Guidelines

Perinatal Palliative Care: ACOG COMMITTEE OPINION, Number 786

ACOG, 2019 Obstet Gynecol

Perinatal palliative care refers to a coordinated care strategy that comprises options for obstetric and newborn care that include a focus on maximizing quality of life and comfort for newborns with a variety of conditions considered to be life-limiting in early infancy. With a dual focus on ameliorating suffering and honoring patient values, perinatal palliative care can be provided concurrently with life-prolonging treatment. The focus of this document, however, involves the provision of exclusively palliative care without intent to prolong life in the context of a life-limiting condition, otherwise known as perinatal palliative comfort care. Once a life-limiting diagnosis is suspected antenatally, the tenets of informed consent require that the pregnant patient be given information of sufficient depth and breadth to make an informed, voluntary choice for her care. Health care providers are encouraged to model effective, compassionate communication that respects patient cultural beliefs and values and to promote shared decision making with patients. Perinatal palliative comfort care is one of several options along a spectrum of care, which includes pregnancy termination (abortion) and full neonatal resuscitation and treatment, that should be presented to pregnant patients faced with pregnancies complicated by life-limiting fetal conditions. If a patient opts to pursue perinatal palliative comfort care, a multidisciplinary team should be identified with the infrastructure and support to administer this care. The perinatal palliative care team should prepare families for the possibility that there may be differences of opinion between family members before and after the delivery of the infant, and that there may be differences between parents and the neonatal care providers about appropriate postnatal therapies, especially if the postnatal diagnosis and prognosis differ substantially from antenatal predictions. Procedures for resolving such differences should be discussed with families ahead of time.

Birth Setting and Provider · Hospital Birth

The Giving Voice to Mothers study: inequity and mistreatment during pregnancy and childbirth in the United States

Vedam S et al., 2019 Reproductive Health

Recently WHO researchers described seven dimensions of mistreatment in maternity care that have adverse impacts on quality and safety. Applying the WHO framework for quality care, service users partnered with NGOs, clinicians, and researchers, to design and conduct the Giving Voice to Mothers (GVtM)-US study. Our multi-stakeholder team distributed an online cross-sectional survey to capture lived experiences of maternity care in diverse populations. Patient-designed items included indicators of verbal and physical abuse, autonomy, discrimination, failure to meet professional standards of care, poor rapport with providers, and poor conditions in the health system. We quantified the prevalence of mistreatment by race, socio-demographics, mode of birth, place of birth, and context of care, and describe the intersectional relationships between these variables. Of eligible participants (n = 2700), 2138 completed all sections of the survey. One in six women (17.3%) reported experiencing one or more types of mistreatment such as: loss of autonomy; being shouted at, scolded, or threatened; and being ignored, refused, or receiving no response to requests for help. Context of care (e.g. mode of birth; transfer; difference of opinion) correlated with increased reports of mistreatment. Experiences of mistreatment differed significantly by place of birth: 5.1% of women who gave birth at home versus 28.1% of women who gave birth at the hospital. Factors associated with a lower likelihood of mistreatment included having a vaginal birth, a community birth, a midwife, and being white, multiparous, and older than 30 years. Rates of mistreatment for women of colour were consistently higher even when examining interactions between race and other maternal characteristics. For example, 27.2% of women of colour with low SES reported any mistreatment versus 18.7% of white women with low SES. Regardless of maternal race, having a partner who was Black also increased reported mistreatment. This is the first study to use indicators developed by service users to describe mistreatment in childbirth in the US. Our findings suggest that mistreatment is experienced more frequently by women of colour, when birth occurs in hospitals, and among those with social, economic or health challenges. Mistreatment is exacerbated by unexpected obstetric interventions, and by patient-provider disagreements.

NaProTechnology · Program Outcomes

A Quantitative Self-Assessment of Seminarians' Response to a Curriculum Addition on Marriage, Sexuality, FertilityCare, and Naprotechnology: The Kenrick-Glennon Experience (2006-2015)

Daly KD et al., 2019 Linacre Q

A special course on Marriage, the Family and Human Sexuality was established at Kenrick-Glennon Seminary in St. Louis so as to assist the seminarians in their better understanding of the Church's teaching relative to natural methods of family planning and women's health care. This article compares the response at the beginning of this three-credit semester course to the same seven-item questionnaire given at the conclusion of the course. The preand postcourse scores were calculated for each of the questions. The scores obtained after the course were all significantly higher than they were before the course with p values ranging from 0.01 to <0.0001. Four of the items showed marked improvement including an understanding of the church's teaching related to natural methods, current methods of natural family planning, the impact of a natural method on a couple's marriage, and also the impact of a natural method on family life. Statistically significant improvement was also seen in their understanding of the topic of natural family planning and the Creighton Model System and its relevance toward the seminarian's vocation, the use of the methods to either achieve or avoid pregnancy, and how contraception and abortion are linked. In these last three items, the level of statistical significance was quite high, although not as high as the other four items. There were 104 seminarians over an eight-year period of time, who provided answers to these questions, both before and after the course. This course was modeled after a course that was initiated at the Pope Paul VI Institute for the Study of Human Reproduction, which was for priests, seminarians, and Catholic leaders, titled Love & Life Unlimited. NONTECHNICAL This is an evaluation of a ten-point, seven-question questionnaire that was utilized at the beginning of a course at Kenrick Seminary in Marriage, Sexuality, Creighton Model and NaProTECHNOLOGY. The same questionnaire was given to the students at the beginning of the course and then two to three months later at the conclusion of the three-credit course. The results show that there is a significant improvement in the seminarians' knowledge and general attitude about natural methods of family planning and suggests that such courses would be beneficial to establish in seminaries throughout the country.

Access and Coverage · Workforce and Availability

The Impact of Access Barriers on Fertility Treatment Decision Making: A Qualitative Study From the Perspectives of Patients and Service Providers

Maxwell E et al., 2018 Journal of Obstetrics and Gynaecology Canada

The purpose of this study was to explore how barriers to accessing fertility services affect the treatment decisions made by fertility patients and service providers in Newfoundland and Labrador. Semistructured, in-depth interviews were conducted with 11 patients across Newfoundland and with eight service providers from Newfoundland and Labrador Fertility Services (located in St. John's) to gather the perspectives of both patients and providers. The interview transcripts were analyzed thematically. Patients' responses to fertility service access barriers included choosing cheaper drugs, substituting intrauterine insemination (IUI) for IVF or not using IVF, delaying IVF, choosing more accessible IVF clinics, transferring multiple embryos, and stopping treatment altogether. Some patients, however, noted that the barriers would not stop them from continuing with treatment. Providers' responses to the barriers patients faced included changing drug protocols, manipulating ovulation, providing teleconsultations, and minimizing patients' clinic visits for those living some distance away from St. John's. Both patients and providers make treatment-related decisions to maximize the likelihood of a successful pregnancy and to reduce costs, which can result in less effective care and at times increased risk to the patient. Unlike with other types of care, responses to barriers to fertility treatment largely result in changes to individual patient treatment plans rather than changing models of care. As a result, many patients must continue to seek fertility services in large urban centres and incur substantial personal costs.

Cesarean Birth · Cesarean Indications and Rates

The Future of Cesarean Delivery Rates in the United States

Clapp MA et al., 2017 Clin Obstet Gynecol

The US cesarean delivery rate remains 30%-32%. Increases in maternal age, obesity, and diabetes put upward pressure on this rate. Alternatives to cesarean delivery, vaginal birth after cesarean (VBAC), and operative vaginal delivery, are underutilized and there are substantial challenges to their resurgence. Practice guidelines offer promise, but demonstrate only minor reductions in cesarean delivery. We estimate that the overall rate in the US will remain 27%-30% for the immediate future. As more states move to recognize the independent practice of midwifery and more payers seek lower cost options for childbirth, we anticipate the overall rate will drop to 20% or 25%, but not for another 15 years or more.

Breast Health · Breast Cancer Risk

Breastfeeding and Breast Cancer Risk Reduction: Implications for Black Mothers

Anstey EH et al., 2017 Am J Prev Med

Breast cancer is the most commonly diagnosed cancer and a leading cause of death from cancer among U.S. women. Studies have suggested that breastfeeding reduces breast cancer risk among parous women, and there is mounting evidence that this association may differ by subtype such that breastfeeding may be more protective of some invasive breast cancer types. The purpose of this review is to discuss breast cancer disparities in the context of breastfeeding and the implications for black mothers. Black women in the U.S. have lower rates of breastfeeding and nearly twice the rates of triple-negative breast cancer (an aggressive subtype) compared with white women. In addition to individual challenges to breastfeeding, black women may also differentially face contextual barriers such as a lack of social and cultural acceptance in their communities, inadequate support from the healthcare community, and unsupportive work environments. More work is needed to improve the social factors and policies that influence breastfeeding rates at a population level. Such efforts should give special consideration to the needs of black mothers to adequately address disparities in breastfeeding among this group and possibly help reduce breast cancer risk. Interventions such as peer counseling, hospital policy changes, breastfeeding-specific clinic appointments, group prenatal education, and enhanced breastfeeding programs have been shown to be effective in communities of color. A comprehensive approach that integrates interventions across multiple levels and settings may be most successful in helping mothers reach their breastfeeding goals and reducing disparities in breastfeeding and potentially breast cancer incidence.

NaProTechnology · Protocols and Framework

Troska o zdrowie prokreacyjne w naprotechnologii ─ formą budowania nowej kultury życia ludzkiego

Bożena BB, 2017 10.14746/tim Open Access

NaProTECHNOLOGY is a new field of medicine specializing in the promotion of human procreation. Its foundation is a teaching system called the Creighton Model Fertility Care System. It is based on the ability to observe and record biological biomarkers, enabling spouses to recognize and understand the naturally occurring cycle of fertility and infertility. The spouses can use their acquired knowledge both for achiving pregnancy and avoiding pregnancy. The system also enables them to broaden their knowledge to better understand sexuality and deepen their mutual love. It also plays an important role in diagnosing and treating reproductive health according to the natural cycle of women. NaProTECHNOLOGY is involved in building a "new culture of life" through integral concern for human fertility by restoring natural procreation and respecting the principles of responsible parenthood.

Guidelines by Clinical Area · Obstetric Guidelines

Committee Opinion No. 691: Carrier Screening for Genetic Conditions

ACOG, 2017 Obstet Gynecol

Carrier screening is a term used to describe genetic testing that is performed on an individual who does not have any overt phenotype for a genetic disorder but may have one variant allele within a gene(s) associated with a diagnosis. Information about carrier screening should be provided to every pregnant woman. Carrier screening and counseling ideally should be performed before pregnancy because this enables couples to learn about their reproductive risk and consider the most complete range of reproductive options. A patient may decline any or all screening. When an individual is found to be a carrier for a genetic condition, his or her relatives are at risk of carrying the same mutation. The patient should be encouraged to inform his or her relatives of the risk and the availability of carrier screening. If an individual is found to be a carrier for a specific condition, the patient's reproductive partner should be offered testing in order to receive informed genetic counseling about potential reproductive outcomes. If both partners are found to be carriers of a genetic condition, genetic counseling should be offered. What follows is a detailed discussion of some of the more common genetic conditions for which carrier screening is recommended in at least some segments of the population.

Infections · Vaginal and Cervical Infections

NaProTechnology: science and the person in human papillomavirus (HPV) infection among women and preadolescents

Murcia-Lora JM et al., 2017 pers. bioet Open Access

En la actualidad hay suficiente evidencia científica que relaciona directamente adquisición, exposición y prevalencia del virus del papiloma humano (VPH) con el cáncer del cuello de uterino. Por ello, el artículo aborda el VPH en la mujer teniendo en cuenta la naprotecnología, que permite conjugar evidencia científica y planteamientos éticos. Se busca que se tengan en cuenta tanto el aspecto biológico de la sexualidad como la capacidad de hacerse persona en su núcleo sexual. De ahí que se analicen programas dirigidos a la educación sexual, basados tanto en la prevención sanitaria como en la antropología de la sexualidad, y apoyados por las instituciones familiares, que han demostrado una mejor acogida ante los riesgos de las enfermedades de transmisión sexual, y entre ellas la infección por el VPH.

Guidelines by Clinical Area · Fertility and Infertility Guidelines

Recommendations for practices utilizing gestational carriers: a committee opinion

Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the Society for Assisted Reproductive Technology. Electronic address: ASRM@asrm.org et al., 2017 Fertility and sterility

This document provides the latest recommendations for evaluation of gestational carriers and intended parents. It incorporates recent information from the US Centers for Disease Control and Prevention, the US Food and Drug Administration, and the American Association of Tissue Banks, with which all programs offering gestational carrier services must be thoroughly familiar. This document replaces the previous document of the same name, last published in 2015 (Fertil Steril® 2015; 103:e1-8).

Registries and Reporting · Success Rate Reporting

Direct-to-consumer advertising of success rates for medically assisted reproduction: a review of national clinic websites

Wilkinson J et al., 2017 BMJ Open Open Access

To establish how medically assisted reproduction (MAR) clinics report success rates on their websites. Websites of private and NHS clinics offering in vitro fertilisation (IVF) in the UK. We identified clinics offering IVF using the Choose a Fertility Clinic facility on the website of the Human Fertilisation and Embryology Authority (HFEA). Of 81 clinics identified, a website could not be found for 2, leaving 79 for inclusion in the analysis. PRIMARY Outcome measures reported by clinic websites. The numerator and denominator included in the outcome measure were of interest. 53 (67%) websites reported their performance using 51 different outcome measures. It was most common to report pregnancy (83% of these clinics) or live birth rates (51%). 31 different ways of reporting pregnancy and 9 different ways of reporting live birth were identified. 11 (21%) reported multiple birth or pregnancy rates. 1 clinic provided information on adverse events. It was usual for clinics to present results without relevant contextual information such as sample size, reporting period, the characteristics of patients and particular details of treatments. Many combinations of numerator and denominator are available for the purpose of reporting success rates for MAR. The range of reporting options available to clinics is further increased by the possibility of presenting results for subgroups of patients and for different time periods. Given the status of these websites as advertisements to patients, the risk of selective reporting is considerable. Binding guidance is required to ensure consistent, informative reporting.

Long Acting Methods · Intrauterine Devices

Long-acting contraceptives for adolescents

Fitzgerald JE, 2016 Natl Cathol Bioeth Q

In 2014, the American Academy of Pediatrics published its policy statement on contraception for adolescents, which provides, in effect, a mandate to temporarily sterilize all adolescents with long-acting reversible contraceptives for five to ten years. The author reviews the AAP guidelines and their effects on Catholic adolescents, their families, and adolescent health care providers. He then discusses medicolegal issues raised by the policy, outlines Catholic strategies for combating it, and proposes a diocese-based physician-led program for teaching and counseling elementary and high school students.

Guidelines by Clinical Area · Fertility and Infertility Guidelines

Perinatal risks associated with assisted reproductive technology: committee opinion no. 671

American College of Obstetricians and Gynecologists, 2016 Obstetrics and Gynecology

Over the past decades, the use of assisted reproductive technology (ART) has increased dramatically worldwide and has made pregnancy possible for many infertile couples. Although the perinatal risks that may be associated with ART and ovulation induction are much higher in multifetal gestations, even singletons achieved with ART and ovulation induction may be at higher risk than singletons from naturally occurring pregnancies. However, it remains unclear to what extent these associations might be related to the underlying cause(s) of infertility. Before initiating ART or ovulation induction procedures, obstetrician-gynecologists and other health care providers should complete a thorough medical evaluation to ensure that patients are in good health and should counsel these women about the risks associated with treatment. Any maternal health problems or inherited conditions should be addressed. Couples at risk of passing genetic conditions on to their offspring, including those due to infertility-associated conditions, should be counseled appropriately. When a higher-order (triplet or more) multifetal pregnancy is encountered, the option of multifetal reduction should be discussed. In the case of a continuing higher-order multifetal pregnancy, ongoing obstetric care should be with an obstetrician-gynecologist or other obstetric care provider and at a facility capable of managing anticipated risks and outcomes.

Procedures and Protocols · IVF Protocols

Od eugeniki do procedury zapłodnienia in vitro

Gruszka MJ, 2015 Seminare Open Access

In vitro fertilization (IVF) is a method known almost all over the world, by which modern man is trying to cope with the problem of infertility. The aim of this article is to show the eugenic roots of in vitro and to attempt to reconciliate the supporters and opponents of this controversial procedure at a NaProTechnological plane. In order to achieve this, the author characterizes IVF from the technical, medical and legal point of view. Then, the article shows the relationship between the in vitro procedure and eugenic thought. The third section contextualizes the problem of artificial insemination in the contemporary, human uncritical faith in technological progress. The last part of this article directs the reader's attention towards NaProTechnology – a method of infertility treatement which can engage both the supporters and the opponents of IVF.

Ovarian Hormones · Progesterone

Mechanism of action of levonorgestrel emergency contraception

Kahlenborn C et al., 2015 Linacre Q

There has been much debate regarding levonorgestrel emergency contraception's (LNG-EC's) method of action since 1999 when the Food and Drug Administration first approved its use. Proponents of LNG-EC have argued that they have moral certitude that LNG-EC works via a non-abortifacient mechanism of action, and claim that all the major scientific and medical data consistently support this hypothesis. However, newer medical data serve to undermine the consistency of the non-abortifacient hypothesis and instead support the hypothesis that preovulatory administration of LNG-EC has significant potential to work via abortion. The implications of the newer data have important ramifications for medical personnel, patients, and both Catholic and non-Catholic emergency room protocols. In the future, technology such as the use of early pregnancy factor may have the potential to quantify how frequently preovulatory LNG-EC works via abortion. Lay How Plan B (levonorgestrel emergency contraception) works has been vigorously debated ever since the Food and Drug Administration approved it in 1999. Many doctors and researchers claim that it has either no-or at most-an extremely small chance of working via abortion. However, the latest scientific and medical evidence now demonstrates that levonorgestrel emergency contraception theoretically works via abortion quite often. The implications of the newer data have important ramifications for medical personnel, patients, and both Catholic and non-Catholic emergency room rape protocols.

Prescribing Safety · Medication Safety in Pregnancy

Treating morning sickness in the United States--changes in prescribing are needed

Koren G, 2014 American journal of obstetrics and gynecology Open Access

Presently, 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration. The use of ondansetron for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias. In April 2013, the Food and Drug Administration approved the combination of doxylamine and pyridoxine, specifically for nausea and vomiting in pregnancy symptoms. Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.

Safety and Risks · Cumulative Iatrogenic Burden

Are we overusing IVF?

Kamphuis EI et al., 2014 BMJ

The indications for IVF have expanded from tubal disorders to many causes of subfertility, including unexplained. But with limited evidence underpinning its extended remit Esme Kamphuis and colleagues explain how the risks could outweigh the benefits.

Access and Coverage · Insurance Coverage

The impact of consumer affordability on access to assisted reproductive technologies and embryo transfer practices: an international analysis

Chambers GM et al., 2014 Fertil Steril

Comment in Fertil Steril. 2014 Jan;101(1):47-8. doi: 10.1016/j.fertnstert.2013.09.043. To systematically quantify the impact of consumer cost on assisted reproduction technology (ART) utilization and numbers of embryos transferred. Ordinary least squared (OLS) regression models were constructed to measure the independent impact of ART affordability-measured as consumer cost relative to average disposable income-on ART utilization and embryo transfer practices. Not applicable. PATIENT(S): Women undergoing ART treatment. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): OLS regression coefficient for ART affordability, which estimates the independent effect of consumer cost relative to income on utilization and number of embryos transferred. RESULT(S): ART affordability was independently and positively associated with ART utilization with a mean OLS coefficient of 0.032. This indicates that, on average, a decrease in the cost of a cycle of 1 percentage point of disposable income predicts a 3.2% increase in utilization. ART affordability was independently and negatively associated with the number of embryos transferred, indicating that a decrease in the cost of a cycle of 10 percentage points of disposable income predicts a 5.1% increase in single-embryo transfer cycles. CONCLUSION(S): The relative cost that consumers pay for ART treatment predicts the level of access and number of embryos transferred. Policies that affect ART funding should be informed by these findings to ensure equitable access to treatment and clinically responsible embryo transfer practices.

NaProTechnology · Protocols and Framework

NFP and NaProTechnology

Watt H, 2013 Linacre Q

As the editor of the Anscombe Bioethics Centre's new book Fertility and Gender: Issues in Reproductive and Sexual Ethics (Watt 2011), I was delighted to read Sr. Renee Mirkes’ generous review in th...

Cervical Factor · Mucus Deficiency

The Evaluation and Treatment of Cervical Factor Infertility a Medical-Moral Analysis

Keefe CE et al., 2012 Linacre Q

The current approach to infertility of assisted reproductive technology (ART) completely misses and then bypasses the evaluation and treatment of cervical factor infertility. In contrast, the Creighton Model Fertility Care System (CrMS), a method of fertility awareness that has the unique ability to quantify cervical mucus observations, and natural procreative technology (NaProTECHNOLOGY or NPT) directly evaluate and treat cervical factor infertility. The ART treatment of choice for cervical factor infertility--intrauterine insemination (IUI)--is also morally disparate from the NPT treatment protocol: while the latter genuinely assists the infertile couple's act of sexual union to achieve its natural end of pregnancy, IUI replaces the natural act, depriving human conception of the one context worthy of the dignity of human life and procreation, a reciprocal self-gifting act of love between husband and wife. A renewed interest and focus on the direct evaluation and treatment of cervical factor infertility is needed.

Restorative Care and Assisted Reproduction · Outcome Comparisons

Assisted reproductive techniques and NaProTechnology

Dowbór-Dzwonka A et al., 2012 Zdr Publ Open Access

Infertility is a significant and constantly increasing individual and social problem. It is estimated that at present it affects approx. 15 to 20 percent of couples. Inability to conceive a child elicits a range of unfavourable implications in the scope of emotional experiences, in the partner’s relationship and in a broader social perspective. Making a decision on undergoing diagnostics and infertility treatment is a difficult and often postponed moment for many couples. This is an expression of the escape model of dealing with a situation that threatens with a fall of self-esteem. However, if a couple reacts in a task-oriented way and participates in the diagnostic and therapeutic procedure, new doubts appear connected with the medical, psychological, social and ethical sphere. Infertility treatment sometimes prompts fear connected with the stripping of intimacy, loss of control over one’s body, possible complications and unsuccessful therapy. This article is an analysis of the medical and the other aspects of struggling with infertility with reference to two extremely different methods of solving this NaProTechnology as a process of assisting natural procreation and assisted reproductive techniques with a special consideration of in vitro fertilization.

Comparative Studies · Contraception Versus Fertility Awareness

Family Planning, Natural Family Planning, and Abortion Use among U.S. Hispanic Women: Analysis of Data from Cycle 7 of the National Survey of Family Growth

Rodriguez D et al., 2012 Linacre Q Open Access

Hispanics are the largest minority group in the U.S. and they contribute to over 50 percent of Catholics under the age of 25. The purpose of this study was to determine the patterns of contraceptive use (current and ever), natural family planning (NFP), and abortion among U.S. Hispanic women between the ages of 15 and 44 years and to compare their patterns of use to non-Hispanic women of the same age range. A particular interest was to determine the influence of faith on the choice of family-planning methods among the sexually active U.S. Catholic Hispanic women. Data for this study came from the National Survey of Family Growth 2006-2008, which included 1,613 Hispanic and 5,743 non-Hispanic women between the ages of 15 and 44. Approximately 57 percent of the Hispanic women are Catholic. In general, U.S. Hispanic women had significantly less frequent use of the hormonal pill, male condom, withdrawal, and vasectomy (of male partner) but more frequent use of the IUD and Depo-Provera compared to non-Hispanic women. There was little use of NFP and no difference in the frequency of reported abortion. Catholic Hispanic women had significantly less frequent use of the male condom, the Pill, vasectomy, and abortion and more use of NFP compared to non-Catholic Hispanic women. Although there is some positive influence of faith among the sexually active Hispanic women of reproductive age, overall, the amount of ever use of sterilization (21 percent), condom use (80 percent), Pill use (66 percent), and Depo-Provera (30 percent) is remarkable. The more frequent use of Depo-Provera and the IUD might reflect the economic level of the participants and the use of federally funded family-planning services.

Prescribing Safety · Medication Safety in Pregnancy

Significant Risks of Oral Contraceptives (OCPs): Why This Drug Class Should Not Be Included in a Preventive Care Mandate

Peck R et al., 2012 Linacre Q Open Access

Pregnancy is not a disease. But more fundamentally, neither is human fertility. They are normal physiologic processes of the sexually mature person. By classifying pregnancy and fertility as disease states, certain entities are able to position contraception as "the cure." Currently, these same organizations want to include oral contraceptive counseling and medications in the new national health-care plan under a preventive care mandate. But it is the physician's role to counsel patients on preventive care measures. We understand that these evidenced-based screenings help to change risky behaviors and catch disease in its earliest stages, thereby reducing patients' overall morbidity and mortality. However, we believe that patients incur substantial health risks when choosing oral contraceptives (OCPs). This paper reviews the major risks of OCPs. The authors presume that the prevailing widespread acceptance and promotion of OCPs indicates general agreement within the medical community that OCPs are good for the patient (or at least not significantly harmful). Therefore, this paper concentrates on the studies which show increased harm and risk to the patient choosing to use OCPs. We have concentrated our efforts on three major areas: increased rates of cardiovascular disease, breast cancer, and human papillomavirus (HPV) or cervical cancer. If fertility and pregnancy are not disease states, and are, in fact, normal conditions associated with healthy individuals, OCPs fail the most important test of preventive medicine: they increase risk of disease instead of decreasing it. Patients should not be misled or confused into believing that what they are taking is "good for them" and is of the same beneficial effect as other preventive measures.

Gynecologic Oncology · Ovarian Cancer

Reducing uterine and ovarian mortality risks of religious sisters

Hemphill CK et al., 2012 Natl Cathol Bioeth Q

Consecrated women religious have been shown to be at increased risk for uterine and ovarian cancers. The authors critique a proposal by Kara Britt and Roger Short advocating the distribution of a combined oral contraceptive to women religious as a way of reducing this risk. The authors argue that the proposal is seriously flawed: the data it references attenuate its conclusion, the execution protocol is incomplete, and the proposal fails to address the serious health risks of combined oral contraceptives. As a counterproposal, the authors recommend that women religious be taught to monitor their gynecologic health by charting their menstrual and ovulatory cycles. National Catholic Bioethics Quarterly 12.2 (Summer 2012): 235–239.

Hormonal Agents · Estrogen Preparations

Bioidentical hormone therapy

Files JA et al., 2011 Mayo Clinic proceedings Open Access

The change in hormonal milieu associated with perimenopause and menopause can lead to a variety of symptoms that can affect a woman's quality of life. Postmenopausal hormone therapy (HT) is an effective, well-tolerated treatment for these symptoms. However, combined HT consisting of conjugated equine estrogen and medroxyprogesterone acetate has been associated with an increased number of health risks when compared with conjugated equine estrogen alone or placebo. As a result, some women are turning to alternative hormonal formulations known as compounded bioidentical HT because they perceive them to be a safer alternative. This article defines compounded bioidentical HT and explores the similarities and differences between it and US Food and Drug Administration-approved HT. We will examine the major claims made by proponents of compounded bioidentical HT and recommend strategies for management of patients who request bioidentical HT from physicians.

Nutrition and Metabolic Health · Dietary Patterns

Folic acid food fortification-its history, effect, concerns, and future directions

Crider KS et al., 2011 Nutrients

Periconceptional intake of folic acid is known to reduce a woman's risk of having an infant affected by a neural tube birth defect (NTD). National programs to mandate fortification of food with folic acid have reduced the prevalence of NTDs worldwide. Uncertainty surrounding possible unintended consequences has led to concerns about higher folic acid intake and food fortification programs. This uncertainty emphasizes the need to continually monitor fortification programs for accurate measures of their effect and the ability to address concerns as they arise. This review highlights the history, effect, concerns, and future directions of folic acid food fortification programs.

Grief and Loss · Stillbirth and Infant Loss

Providing hospice in the womb

Collier R, 2011 CMAJ Open Access

Amy Kuebelbeck was 25 weeks into her pregnancy when she received the terrible news. Her fetus had been diagnosed with an incurable heart defect. If she carried through with her pregnancy, her baby's life would be a brief one. Kuebelbeck did continue her pregnancy and gave birth to a boy. Her new

Access and Coverage · Workforce and Availability

In vitro fertilization availability and utilization in the United States: a study of demographic, social, and economic factors

Hammoud AO et al., 2009 Fertil Steril

To characterize the demographic correlates of IVF availability and utilization. Demographic analysis of public data. Each of the 50 states in the United States was used as a unit of analysis. PATIENT(S): Patients undergoing IVF, as demographically estimated. INTERVENTION(S): Publicly available data were collected through the Society for Assisted Reproductive Technology and the Centers for Disease Control. The US Census Bureau data were collected by using software available from the Centers for Disease Control. MAIN OUTCOME MEASURE(S): The number of physicians performing IVF and the number of IVF cycles per 100,000 reproductive-age women were used to estimate IVF availability and utilization. RESULT(S): In 2005, 1,031 providers performed 98,242 fresh IVF cycles in 430 centers. Overall availability was 2.5 IVF physicians per 100,000, and utilization was 236 IVF cycles per 100,000. Availability and utilization of IVF were highly correlated. Mean IVF availability and utilization were significantly higher in states with IVF insurance coverage. In adjusted analyses, IVF availability correlated positively with mandated insurance coverage, percentage of single persons, and median income. Utilization of IVF correlated with IVF availability, percentage urbanization, and percentage of individuals >or=25 years of age who had a bachelor's degree. CONCLUSION(S): Lower rates of IVF utilization in some states are correlated with a lack of insurance coverage and decreased availability of physicians providing this service.

Effectiveness · Typical and Perfect Use

Efficacy and Efficiency in Natural Family Planning Services

Fehring RJ, 2009 Linacre Q

Relatively few Catholic couples in the United States use modern methods of natural family planning (NFP). So too, few Catholic physicians and health professionals prescribe the use of NFP methods for their patients. Reasons for low use of NFP methods include their perceived low efficacy; the complexity of learning, using, and teaching these methods; and the prolonged (and often unnecessary) required abstinence. Newer and simplified methods of NFP have been developed by physicians and scientists that are less complex and use modern technologies of detecting fertility and communicating instructions. Catholic physicians and scientists need to continue to answer the call by the Holy Fathers (from Pius XII to Benedict XVI) to develop secure and scientifically sound methods of NFP.

Hormonal Agents · Progesterone and Progestins

No justification for using IUD to treat menorrhagia

Raviele KM, 2008 Linacre Q

This article questions the conclusions drawn by the author of "The Mirena® Levonorgestrel-releasing Intrauterine System and Its Application to the Treatment of Menorrhagia: A Moral Opinion" (Linacre Quarterly 75 [2008]: 60–70), i.e., that it is justified to use this intrauterine device to treat heavy periods of unknown etiology by the principle of double effect.

Comparative Studies · Contraception Versus Fertility Awareness

Factors influencing the choice to use modern natural family planning

Rauchfuss M et al., 2003 Contraception

A discrepancy exists between the interest in modern methods of natural family planning (NFP) and their actual use in developed countries. To explore reasons for this discrepancy, we analyzed data from a questionnaire administered to postpartum women in Berlin (n = 223) and Cracow (n = 233). Knowledge of NFP, past use of NFP and expected effects of abstinence on the partnership were independently associated with interest in using NFP, but not the choice to do so among those interested. Desire for future pregnancies, importance of religious belief and location in Cracow were independently associated with the choice to use NFP among those interested. Perceived accuracy of observation to identify the fertile time and acceptance of own body were independently associated with both interest in and choice to use NFP. Frequency of intercourse had no effect on interest. These results suggest that increased access and cultural support would likely lead to a higher prevalence of NFP use in developed countries.

Ovarian Hormones · Progesterone

Postfertilization effect of hormonal emergency contraception

Kahlenborn C et al., 2002 Ann Pharmacother

To assess the possibility of a postfertilization effect in regard to the most common types of hormonal emergency contraception (EC) used in the US and to explore the ethical impact of this possibility. DATA A MEDLINE search (1966-November 2001) was done to identify all pertinent English-language journal articles. A review of reference sections of the major review articles was performed to identify additional articles. Search terms included emergency contraception, postcoital contraception, postfertilization effect, Yuzpe regimen, levonorgestrel, mechanism of action, Plan B. The 2 most common types of hormonal EC used in the US are the Yuzpe regimen (high-dose ethinyl estradiol with high-dose levonorgestrel) and Plan B (high-dose levonorgestrel alone). Although both methods sometimes stop ovulation, they may also act by reducing the probability of implantation, due to their adverse effect on the endometrium (a postfertilization effect). The available evidence for a postfertilization effect is moderately strong, whether hormonal EC is used in the preovulatory, ovulatory, or postovulatory phase of the menstrual cycle. Based on the present theoretical and empirical evidence, both the Yuzpe regimen and Plan B likely act at times by causing a postfertilization effect, regardless of when in the menstrual cycle they are used. These findings have potential implications in such areas as informed consent, emergency department protocols, and conscience clauses.

Adverse Effects · Mood and Libido

Embryocidal Effects of Contemporary Contraceptives: A Review

AAPLOG, 1999

The mechanism of action of contraceptive drugs and devices forms an essential part of informed consent for patients considering various methods of family planning. Currently the literature is confusing at best, in part due to non-uniform definitions of basic terms, as well as the misinterpretation of endpoints of current. AAPLOG members take different positions on the issue of contraception per se. The purpose of this document is to investigate and summarize the current evidence-based concerns regarding potential embryocidal mechanisms of action of modern contraceptive drugs and devices. There are three reasons for concern about embryos conceived during the use of a particular contraceptive drug or device: 1. 1) All contraceptive drugs and devices “fail” at a certain rate. As noted in a recent paper, “Unintended pregnancies occur with all contraceptive methods, including IUDs. This provides incontrovertible evidence that fertilization and implantation can occur, albeit rarely, with modern methods of contraception.”1 2. 2) Since pregnancies can and do occur during the use of all contraceptive drugs and devices, then we know by definition that fertilization, which marks the beginning of an embryonic human organism, can and does happen with all contraceptive drugs and devices since by definition, an embryo must be created for pregnancy to occur. That means embryos are created at a certain rate with all contraceptive drugs or devices. 3. 3) The contraceptive drug or device will create a certain environment for the embryos created during their use. This environment may adversely affect embryo survival up to the point of yielding a positive pregnancy test at the end of the cycle (the contraceptive efficacy end point). The remainder of this article will try to summarize what is known in the published medical literature about the environment facing an embryo who has been created during the use of various kinds of contraceptive drugs or devices.

Access and Coverage · Insurance Coverage

Infertility services and managed care

Bron MS et al., 1998 Am J Manag Care

The birth of the McCaughey septuplets in Iowa in November 1997 brought issues of fertility assistance and their potential outcomes to worldwide attention. This Pergonal-stimulated multiple pregnancy ended successfully, but not without health hurdles and economic consequences for the new siblings and their family. This article reviews the general situation surrounding infertility services and, within the current debate of epidemiological, economic, legal and social issues, posits that managed care may be able to make greater strides than the present fee-for-service system in providing more accessible and comprehensive care to the 5.3 million US citizens at risk for infertility. Our conclusions suggest that managed care plans for infertility can aid in assuring quality and decreasing unnecessary costs. Managed care organizations should take the lead in providing infertile couples with an organized, humanistic approach that is mindful of the attending social issues. On May 5, 1997, a US District court in Chicago ruled that infertility fits the definition of a disability, and thus is subject to the antidiscrimination enforcement under the Americans with Disabilities Act.

Donor Gametes and Surrogacy · Sperm and Embryo Donation

Donor insemination: a comparison of lesbian couples, heterosexual couples and single women

Wendland CL et al., 1996 Fertil Steril

To compare single women, lesbian couples, and heterosexual couples receiving therapeutic donor insemination (TDI). Chart review followed by anonymous mail questionnaires to donor insemination recipients and their partners. Infertility clinic in a university hospital. One hundred fifteen women receiving donor insemination were identified by chart review. Too few single women responded for reliable comparison. Lesbian women were similar to married women in age, education, duration, and outcome of donor insemination. When considering alternatives to TDI, married women were more likely to consider adoption and lesbians were most likely to consider using a known semen donor or having intercourse with a man aware of their desire to have a child. Married couples were less likely to tell others, including the child, about conception by donor insemination. They were also less likely to support disclosing identifying data about the donor to the child. Lesbians were more likely to report stress in their relationships as a result of TDI. Married men were most likely to support mandatory counseling before TDI initiation.

Methods · Creighton Model

The Natural Methods for the Regulation of Fertility: The Authentic Alternative

Hilgers TW, 1995 Linacre Q

The following is an address presented to a summit meeting on natural family planning sponsored by the Pontifical Councilfor the Family in December, 1992 I am honored and privileged to have this opportunity to be with all of you at this summit meeting on natural family planning. I wish to thank Alfonso Cardinal Lopez Trujillo for his invitation and all ofthe members ofthe Pontifical Council for their generosity and hospitality. I have been asked to discuss with you what has become known as the Creighton Model Natural Family Planning System. This system obtained its name from my personal association, in its early days of development, with Creighton University School of Medicine in Omaha, Nebraska. This discussion will be, by its very nature, a summary of work that has been done and work that is currently ongoing. The Creighton Model is referred to as a "model" as opposed to a "method" because it is an integrated education, research and service oriented system which meets the demands of the allied health and medical professions in the field of natural family planning. This system was specifically built to accomplish accountability and competency through a strong professional infra-structure. At the same time, it has been built within the context of a Catholic ethical and moral service delivery framework. It uses a standardized modification of the Billings' Ovulation Method in accomplishing these goals. I personally became involved in natural family planning with a research project I did as a senior medical student in 1968. As I investigated the salivary albumin concentrations in women during the course of their menstrual cycles, I was looking for a reported decrease in albumin around the time of ovulation. Unfortunately, a project which I had no doubt would solve the problems related to natural family planning (sic), proved to be not a very good idea. . .

Definitive and Ablative Procedures · Hysterectomy

Further Evaluation of Uterine Isolation

Hilgers TW, 1994 Linacre Q

"Uterine Isolation" has been discussed, in one form or another, since the early 1940's by such notable American theologians as Fr. John C. Ford, SJ, Fr. Gerald Kelly, SJ; Fr. Francis J. Connell, C.SS.R.; Fr. L. Bender; Fr. John R. Connery; SJ, Fr. Edwin F. Healy, SJ; and Fr. Thomas J. O'Donnell, SJ.l The term "uterine isolation" originated with Fr. O'Donnell. O'Donnell, who is personally convinced of the validity of the arguments for the solid probability of the "uterine isolation" view, was also responsible for having this deleted from the "Ethical and Religious Directives for Catholic Health Facilities" which were published and approved by the bishops in 1971." 'Isolation of the uterus' or 'uterine isolation' " he says, "had taken root in the medical-moral community and, either through misunderstanding or deception, was being used as a presumably morally acceptable semantic for various forms of clearly contraceptive sterilization."l O'Donnell states that the following three points need to be understood by Catholic hospital administration and staff with regard to the term "uterine isolation procedure": 1. Hysterectomy in the presence of a uterus which has been so damaged or weakened by multiple cesarean sections that it is judged to be incapable (because of the damage within the uterus itself) of safely supporting another pregnancy is, with solid probability, not a contraceptive sterilization and is permitted . . . 2. In this case, and only in this case, the isolation of such a uterus at its tubal adnexa, instead of its extirpation, if clinically indicated, is, with solid probability, not a contraceptive sterilization and thus may be permitted and practiced; unless, of course, this is disapproVed by the bishop of the diocese who might well foresee greater harm in the danger of misunderstanding and morally unwarranted extension of the procedure as a semantic to conceal directly contraceptive sterilizations. 3. If, after further study and investigation, there would be a sufficient consensus of theological opinion or a decision by the Congregation for the Doctrine of the Faith that either of the procedures described above (either the hysterectomy in this case or the isolation procedure) is indeed a direct sterilization (such as to discount the solid probability that it is not), then neither of the procedures could be done within the context of Catholic teaching. The sale moral defense of either procedure is the solid probability of the moral opinion that it is not a directly contraceptive sterilization (emphasis applied). I wish to emphasize the need for further study and investigation of this issue because the experience with "uterine isolation" is compelling and proves that the practice is nothing but direct contraceptive sterilization. It is also a practice with inappropriate medical justification . . . a practice which, in the 1990's, cannot be justified on medical moral grounds. One of the most important questions that needs to be asked with regard to "uterine isolation" is "What are we isolating the uterus from?" It is clear that the uterus is not being isolated from either the sperm or the ovum since they present no potential of risk. It is equally clear that the isolation of the uterus, so proposed, is not isolating the uterus from any known disease condition. the only possible thing that this procedure could be isolating the uterus from is a pregnancy . Thus, it seems equally clear that the primary intent of such a "uterine isolation" is contraceptive sterilization. Furthermore, the actual application of "uterine isolation" policies in Catholic hospitals suggests that it is direct contraceptive sterilization.

Procedures and Protocols · Embryo Transfer

Reduction of the number of embryos in a multiple pregnancy: quintuplet to triplet

Brandes JM et al., 1987 Fertil Steril

The technique for reduction of the number of embryos was applied in a patient who conceived following IVF and transfer of six embryos. On the 10th week of gestation, the number of embryos was reduced from five to three by an U/S-guided intra-uterine procedure. Two healthy girls and a boy were delivered in the 36th week by cesarean section. No trace of the other two fetuses was found. The moral and technical aspects of partial preventive termination of multiple pregnancy are discussed.

Methods · Calendar and Rhythm Methods

A second look at natural family planning

Lolarga E, 1983 Initiatives Popul

There is renewed interest in natural family planning (NFP) as the Philippine Population Program enters the 1980s. Much of this interest is due to the realization that, properly practiced, NFP can be a highly effective means of birth spacing. In 1978 the Special Committee to Review the Philippine Population Program recommended that more efforts be made to promote NFP. The different methods of NFP are reviewed. Sex without intercourse, coitus interruptus, and prolonged nursing are not officially recognized as NFP methods by the Program. The rhythm method was first described independently by Drs. Hermann Knaus of Austria and Kyusaku Ogino of Japan in the 1930s. Ogino's method of calculating a woman's fertile period is based on the lengths of the last 12 menstrual cycles which she recorded on a calendar. The advantages of rhythm are that it is inexpensive, it requires only the cost of charts which may be homemade, there are no physical side effects, control is in the woman's hands, and it is acceptable to people who consider it their duty to follow religious teachings. Disadvantages include: keeping constant, accurate records of cycles for long periods of time; the need for perseverance and correct interpretation of the chart; the possible need for medical advice and help; and the fear that something might upset a woman's cycle and change the time of ovulation. The continuation rates of rhythm acceptors in the Philippines are unimpressive. A study of 142 women revealed a high pregnancy/failure rate--25% for a 12-month period compared to 0 with oral contraception (OC) and the IUD's 2%. The basal body temperature method helps determine the unsafe period with some accuracy. Its premise is that there are slight but detectable changes in a woman's body temperature during her cycle. These changes herald ovulation. A special thermometer must record temperature changes of 0.1 degree Farenheit. This instrument and the charts are the only expenses involved. The reviewers of the Philippine Population Program noted that since the end of the unsafe period can be indicated only by the temperature, the total period of abstinence becomes long, although the basal body temperature method gives more or less 10 successive days for intercourse. The cervical mucus method, also known as the Billings method, takes into account the cervical secretions during the menstrual cycle. Appearance of this mucus is an indication of fertility. All that is required of a practitioner is to learn to distinguish the different sensations of wetness and dryness. The disadvantage is that the method becomes ineffective in areas where there is cervicitis or infection of the cervix. The symptom thermal method is the basal body temperature method combined with other NFP techniques and is widely used. With this method an accurate record of the 6 immediately preceding menstrual cycles is established. The start of the fertile period is set by substracting 20 days plus 1. The woman watches for symptoms like pelvic heaviness, breast softness, and mucus discharge.

Adverse Effects · Mood and Libido

Do natural methods for fertility regulation increase the risks of genetic errors?

Serra A, 1981 Bull Nat Fam Plan Counc Vic

Genetic errors of many kinds are connected with the reproductive processes and are favored by a nunber of largely uncontrollable, endogenous, and/or exogenous factors. For a long time human beings have taken into their own hands the control of this process. The regulation of fertility is clearly a forceful request to any family, to any community, were it only to lower the level of the consequences of genetic errors. In connection with this request, and in the context of the Congress for the Family of Africa and Europe (Catholic University, January 1981), 1 question must still be raised and possibly answered. The question is: do or can the so called "natural methods" for the regulation of fertility increase the risks of genetic errors with their generally dramatic effects on families and on communities. It is important to try to give as far as possible a scientifically based answer to this question. Fr. Haring, a moral theologian, citing scientific evidence finds it shocking that the rhythm method, so strongly and recently endorsed again by Church authorities, should be classified among the means of "birth control" by way of spontaneous abortion or at least by spontaneous loss of a large number of zygotes which, due to the concrete application of the rhythm method, lack of necessary vitality for survival. He goes on to state that the scientific research provides overwhelming evidence that the rhythm method in its traditional form is responsible for a disproportionate waste of zygotes and a disproportionate frequency of spontaneous abortions and a defective childern. Professor Hilgers, a reproductive physiologist, takes on opposite view, maintaining that the hypotheses are arbitrary and the alarm false. The strongest evidence upon which Fr. Haring bases his moral principles about the use of the natural methods of fertility regulation is a paper by Guerrero and Rojos (1975). These authors examined, retrospectively, the success of 965 pregnancies which occurred in women who were using the temperature method for family planning and who had recorded the menstrual day of insemination, and they concluded that their results suggested that aging of human spermatozoa in the female genital tract is associated with a increased frequency of spontaneous abortions and that postovulatory aging of human ova results in postimplatation. Their results and conclusions were accepted with great caution by the scientific community. The kind of evidence which suggests that the use of natural methods may increase, in particular cases, the loss of embryos or fetuses, stimulates further research, but it seems a very weak basis for the establishment of principles of human behavior. At the present stage of knowledge the natural methods for the regulation of fertility cannot be qualified as methods which necessarily and considerably increase the risks of abortion of malformed progeny.