The Home Observation of Periconceptional Exposures (HOPE) study, a prospective cohort: aims, design, recruitment and compliance

Porucznik CA; Cox KJ; Wilkins DG; Stanford JB; Schliep KC

doi:10.1186/s12940-016-0153-9

Research Methods · Study Design

The Home Observation of Periconceptional Exposures (HOPE) study, a prospective cohort: aims, design, recruitment and compliance

Porucznik CA, Cox KJ, Wilkins DG, Stanford JB, Schliep KC

Published June 8, 2016 Environmental Health : a Global Access Science Source, 15(1), 67

DOI 10.1186/s12940-016-0153-9 PMID 27277945 PMC PMC4898368

RRM Academy Synopsis

Volunteer couples trying to conceive collected samples at home

Couples trying to conceive returned nearly all requested saliva samples and most semen samples from home. The HOPE study followed 183 couples in a prospective cohort, timing sample collection to the woman's cervical fluid observations. Eleven couples (6.0 %) left the study or were lost to follow up.

Key Findings

Researchers screened 309 eligible couples between 2011 and 2015. A total of 183 enrolled, and 11 of them (6.0 %) dropped out or were lost.
Across both study cycles, women returned 280 of 286 saliva samples (97.9 %) and men returned 278 of 286 (97.2 %). Men returned 257 of 286 semen samples (89.9 %).
Within 3 days either side of estimated ovulation, women gave at least one urine sample in 97.1 % of cycles. Men did so in 91.7 % of cycles.
On the estimated day of ovulation or conception, women gave a urine sample in 239 cycles (86.6 %) and men in 208 cycles (75.4 %).
Online questionnaires were completed at 88 % or higher at every time point. Recruitment cost $37.35 per enrolled couple.

Interpretation

The paper reports how well a study protocol worked. The design is a prospective cohort (couples followed forward in time) of self-selected volunteers with no history of infertility. Most were white (86.9 %) and college educated (60.4 % graduates). The paper reports no pregnancy or exposure results, so the findings speak to feasibility and carry no health conclusions. Men's urine collection was scheduled to stop two days after estimated ovulation, so their later samples were few.

RRM Context

Women's own daily observations of cervical fluid set the sampling schedule for both partners. The authors cite earlier work validating these observations for finding the fertile window. Fertility awareness charting gave the researchers a way to time measurements to ovulation. The design also treats conception as a couple-level event by sampling the woman and the man.

Our editorial summary of this paper, not the article's abstract.

Abstract

Background

To examine transient environmental exposures and their relationship with human fecundity, exposure assessment should occur optimally at the time of conception in both members of the couple. We performed an observational, prospective cohort study with biomonitoring in both members of a heterosexual couple trying to conceive. Couples collected urine, saliva, and semen specimens for up to two menstrual cycles on days corresponding to the time windows of fertilization, implantation, and early pregnancy, identified based on the woman's observations of her cervical fluid.

Results

Three hundred nine eligible couples were screened between 2011 and 2015, of which 183 enrolled. Eleven couples (6.0 %) withdrew or were lost to follow up. The most successful and cost effective recruiting strategies were word of mouth (40 % of participating couples), posters and flyers (37 %), and targeted Facebook advertising (13 %) with an overall investment of $37.35 spent on recruitment per couple. Both men and women collected ≥97.2 % of requested saliva samples, and men collected ≥89.9 % of requested semen samples. Within the periovulatory days (±3 days), there was at least one urine specimen collected by women in 97.1 % of cycles, and at least one by men in 91.7 % of cycles. Daily compliance with periovulatory urine specimens ranged from 66.5 to 92.4 % for women and from 55.7 to 75.0 % for men. Compliance was ≥88 % for questionnaire completion at specified time points.

Conclusions

Couples planning to conceive can be recruited successfully for periconceptional monitoring, and will comply with intensive study protocols involving home collection of biospecimens and questionnaire data.

Topics

Research Methods › Study Design › Cohort Studies · Lifestyle and Environment › Environmental Exposures › Endocrine Disrupting Chemicals

Christina A Porucznik, Karen C Schliep, Joseph B Stanford, Kyley J Cox, Diana G Wilkins

C Porucznik, K Schliep, Joe Stanford, Joey Stanford, J Stanford, K Cox, D Wilkins

PMID 27277945 27277945 DOI 10.1186/s12940-016-0153-9 10.1186/s12940-016-0153-9 Porucznik et al. 2016, Porucznik 2016

Keywords

Adult, Environmental Exposure, Family Characteristics, Female, Fertility, Fertilization, Humans, Male, Prospective Studies, Young Adult, Endocrine Disrupting Chemicals, Fecundity, Ovulation, Preconception, Research Participant Recruitment, Semen

The Home Observation of Periconceptional Exposures (HOPE) study, a prospective cohort: aims, design, recruitment and compliance

Volunteer couples trying to conceive collected samples at home

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

Related research

Keywords