Fertility Awareness Effectiveness

Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial

Smith KR, Varner MW, Stanford JB

Published September 17, 2014 Paediatric and Perinatal Epidemiology, 28(5), 391-399
DOI 10.1111/ppe.12141 PMID 25225008 PMC PMC4861655

RRM Academy Synopsis

Proven-fertile women taught Creighton conceived as often as controls

A randomized trial of 143 women of proven fertility found women taught the Creighton Model FertilityCare System conceived at rates similar to controls. Within seven cycles, 78 out of 100 taught women and 79 out of 100 controls conceived. In the first cycle, 4 out of 100 taught women and 17 out of 100 controls conceived.

Conceived within seven cycles: Creighton Model FertilityCare, 78 in 100; Controls, 79 in 100
Conceived within seven cycles: Creighton Model FertilityCare, 78 in 100; Controls, 79 in 100. Source: Smith KR et al., 2014, PMID 25225008.
Study at a glance, randomized trial: Proven-fertile women taught Creighton conceived as often as controls
Study at a glance, randomized trial of 143 women of proven fertility: Proven-fertile women taught Creighton conceived as often as controls. Source: Smith KR et al., 2014, PMID 25225008.

Key Findings

  • The trial randomized 143 women: 72 to instruction in the Creighton Model FertilityCare System (CrMS, 69 analyzed) and 71 to controls advised to have intercourse 2–3 times per week.
  • Within seven cycles, 56 controls (79%) and 54 CrMS women (78%) conceived, and the adjusted hazard ratio for time to pregnancy was 0.86 (95% CI: 0.53, 1.38).
  • Among cycles with intent to conceive, fecundability (chance of pregnancy per cycle) was 36% with CrMS and 31% in controls (p=0.32).
  • Fecundability in the first cycle was 17% (12/71) in controls and 4% (3/69) with CrMS (p=0.02).
  • Over cycles 2–7 with intent to conceive, adjusted cumulative pregnancy probability by cycle 3 was 63% with CrMS (95% CI 51% to 74%) and 51% in controls (95% CI 40% to 63%).

Interpretation

The study was a parallel randomized trial of women ages 18–35 who had a prior pregnancy and no history of reduced fertility. All participants were asked to begin trying to conceive in the second cycle. The authors believe that the CrMS group had a more compelling reason to wait, learning mucus patterns before semen is present, so more CrMS women followed the instruction. The authors also note that models predict a smaller effect of timing intercourse in couples with more frequent intercourse or higher baseline fecundity.

RRM Context

Restorative reproductive medicine builds on cycle charting. The Creighton Model FertilityCare System teaches women to track and read vaginal secretions that mark the fertile window. The authors cite a randomized trial of 653 women who had tried to conceive for up to 2 years. Women using a monitor to identify the fertile window conceived at a significantly higher rate in the first two cycles. They also cite an observational study of 448 women ages 30–44 that linked consistent mucus checking to a fecundability ratio of 2.1 (95% confidence interval 1.16 to 3.81).

Abstract

Background

The Creighton Model FertilityCare System (CrMS) teaches women to identify days when intercourse is likely to result in pregnancy. We sought to assess the impact of the CrMS on time to pregnancy (TTP), via per-cycle pregnancy rates (fecundability).

Methods

We conducted a parallel randomised trial at the University of Utah School of Medicine, 2003-06. Women ages 18-35 years, in a relationship of proven fertility, who desired to conceive, were block-randomised and stratified for age, with allocation concealment by opaque sequentially numbered sealed envelopes. The control group received the advice to have intercourse 2-3 times per week, and the intervention group received CrMS instruction. All women were asked to begin trying to conceive starting the second cycle in the study and were followed actively up to seven cycles, without blinding of research personnel. We calculated descriptive statistics and fecundability, and estimated Cox models for TTP. (Clinicaltrials.gov NCT00161395).

Results

There were 143 women randomised: 71 to the control group (all analysed) and 72 to the CrMS group (69 analysed). The adjusted hazard ratio for the influence of CrMS on TTP was 0.86 [95% confidence interval (CI): 0.53, 1.38]. Fecundability in cycles with intent to conceive was 31% in controls and 36% with CrMS (P = 0.32). By the first cycle, fecundability was 17% in controls, and 4% with CrMS (P = 0.02). No adverse events were reported.

Conclusions

We found no significant impact of CrMS on TTP or fecundability, but fewer of the women receiving CrMS conceived by the first cycle.

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Fertility Awareness › Effectiveness › Comparative Effectiveness · Restorative Reproductive Medicine › NaProTechnology › Cumulative Pregnancy Rates
Joseph B Stanford, Ken R Smith, Michael W Varner
Joe Stanford, Joey Stanford, J Stanford, Kenneth Smith, K Smith, Mike Varner, M Varner
PMID 25225008 25225008 DOI 10.1111/ppe.12141 10.1111/ppe.12141 Smith et al. 2014, Smith 2014