Fertility Awareness Effectiveness

Fertility awareness-based methods for contraception

Grimes DA, Gallo MF, Grigorieva V, Nanda K, Schulz KF

Published October 18, 2004 The Cochrane Database of Systematic Reviews, 2004(4), CD004860
DOI 10.1002/14651858.CD004860.pub2 PMID 15495128 PMC PMC8855505

RRM Academy Synopsis

Three trials of fertility awareness gave no valid pregnancy rate

This Cochrane review followed three randomized trials of fertility awareness-based birth control, conducted in Colombia and Los Angeles. Most couples in the two larger trials stopped using their method before the trial's observation period began. Pregnancies occurred among couples using both the ovulation and symptothermal methods.

Key Findings

  • The review found three randomized trials, one in Colombia and two in Los Angeles. Weak methods meant the authors could not analyze the data or calculate pregnancy rates.
  • In the Colombia trial of 566 couples, 53% on the ovulation method (149 of 279) and 61% on the symptothermal method (176 of 287) discontinued during training.
  • In the larger Los Angeles trial, 428 of 619 participants assigned to the ovulation method (69%) and 389 of 628 assigned to the symptothermal method (62%) were dropped before the observation period.
  • Reported pregnancies were 72 with the ovulation method and 71 with the symptothermal method in Colombia, and 134 and 75 in the larger Los Angeles trial.
  • The smaller Los Angeles trial was abandoned because of poor recruitment and high drop-out. About one-quarter of its volunteers completed 12 months of follow-up.

Interpretation

The authors note the three trials were poorly conducted and reported, with large losses to follow-up after randomization. Their practice note states that pregnancies occurred with both the ovulation and symptothermal methods, and continuation rates were low. These trials tested the methods only as birth control. Daily cycle charting to understand fertility is a separate use. The findings support larger studies of these methods for contraception.

RRM Context

Restorative reproductive medicine uses cycle charting to track ovulation and cycle health. Charting also helps couples who are trying to conceive. This review judged the ovulation and symptothermal methods only as birth control. Each method was taught in its own program.

Abstract

Background

"Fertility awareness-based methods" (FAB) of family planning "involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time" (WHO 2000). Several names have been used to describe this approach to contraception, including "rhythm," "natural family planning" and "periodic abstinence." Fertility awareness-based methods can be used with abstinence from sexual intercourse. Alternatively, they can be used with barrier contraceptives or withdrawal during presumed fertile times.

Objectives

We retrieved and analyzed all randomized controlled trials that examined any fertility awareness-based methods used for contraception.

Search Strategy

We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, EMBASE, and LILACS (each from its inception to January, 2004) for randomized controlled trials of fertility awareness-based methods. We examined the reference list of each trial as well as that of review articles.

Selection Criteria

We included all randomized controlled trials in any language that compared any fertility awareness-based methods for contraception with a placebo; another method, including an alternative fertility awareness-based method; or fertility awareness-based methods used in conjunction with another contraceptive.

Data Collection and Analysis

We assessed all titles and abstracts found for inclusion. We evaluated the methodological quality of the trials for potential biases by qualitatively assessing the study design; randomization method; allocation concealment; blinding; premature discontinuation rates; and loss to follow-up rates. Because of methodological weaknesses, we could not enter the trial results in RevMan, calculate measures of association, or aggregate data.

Main Results

Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods. In contrast, a companion trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two U.S. trials, recruitment of participants was unexpectedly difficult; this aspect was not mentioned in the report from Colombia. Continuation rates were poor. In the two larger trials, most participants discontinued their assigned method before entering the observation phase of the trial.

Authors' Conclusions

The comparative efficacy of fertility awareness-based methods of contraception remains unknown. Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. Contraceptive methods should be properly evaluated, preferably in randomized controlled trials, before adoption and dissemination.

Read the guide

Topics

By this author

Related research

Fertility Awareness › Effectiveness › Comparative Effectiveness · Contraception › Comparative Studies › Contraception Versus Fertility Awareness
David A Grimes, Maria F Gallo, Kenneth F Schulz
Dave Grimes, D Grimes, M Gallo, Ken Schulz, K Schulz
PMID 15495128 15495128 DOI 10.1002/14651858.CD004860.pub2 10.1002/14651858.CD004860.pub2 Grimes et al. 2004, Grimes 2004