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Luteal phase abnormalities in early menstrual cycles after pregnancy have been shown to cause confusion in the practice of natural family planning (NFP) for some patients and to restrict severely the number of late infertile days available to others. The cause of the abnormalities is uncertain but appears to be related to the nursing status of the patient.
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Oral basal body temperature (BBT) recordings of 46 women that conceived by donor insemination and who had midcycle monitoring of luteinising hormone (LH) were analysed to establish features associated with an optimal cycle. All cycles exhibited a biphasic temperature shift associated with the follicular (mean + SD, 36.5 degrees C +/- 0.22) and luteal phases (36.8 degrees C +/- 0.19). Whilst a mean body temperature rise occurred on Day +1 when all cycles were analysed, individual patterns were seen at ovulation including no change or a decrease in BBT between Day 0 and Day +1. The BBT of the postovulatory phase was stable and only 4.5% of the 644 observations made showed a change of more than 0.2 degrees C from day to day. It was concluded that the BBT charting has limitations when used to recognize the day of ovulation, and that some variable patterns of the early luteal phase are consistent with conception. Finally, optimal luteal phases demonstrated remarkable stability.
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Natural family planning includes the calendar (rhythm), basal body temperature, ovulation (mucus), and sympto-thermal methods. Reliability of such methods often is underestimated, but effectiveness of various methods has been reported. Correct understanding and use of proper techniques, primarily abstinence during fertile periods, is imperative for effectiveness. New methods being studied may heighten awareness of fertile times and shorten required periods of abstinence or use of back-up methods.
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OBJECTIVE: To compare basal body temperature (BBT) graphs and urinary luteinizing hormone (LH) monitoring in scheduling therapeutic donor insemination. DESIGN: Participants were prospectively randomized to the BBT or LH groups. SETTING: Participants were private patients of the Reproductive Endocrine Division at Washington University School of Medicine. PATIENTS: Inclusion criteria were designed to assure an isolated male factor. Seventy-four of 113 patients completed the study; 18 had ongoing treatment at the end of the study. INTERVENTIONS: Basal body temperature graphs were physician interpreted and appointments prospectively chosen. Luteinizing hormone patients monitored daily urine samples and scheduled an appointment the day after the detected surge. MAIN OUTCOME MEASURES: Fecundity rates, cumulative pregnancy rates, and cost per pregnancy were all prospectively evaluated. RESULTS: Life table analysis yielded a 6-month cumulative probability of pregnancy of 36.3% in the LH group and 65.1% in the BBT group (P less than 0.025). The total cost per pregnancy was lower in the BBT group (+6,212 versus +3,997; P less than 0.001). CONCLUSIONS: This randomized prospective study demonstrates significant therapeutic and economic advantages when therapeutic donor insemination is prospectively scheduled by BBT graphs.
The intra- and interwoman variation in nine physiologic or biochemical indices of the fertile period has been studied over 58 menstrual cycles from 13 experienced users of the symptothermal method of family planning by periodic abstinence. The time and duration of a possible fertile period have been determined by five methods (symptothermal, cervical mucus, basal body temperature plus calendar calculation, defined changes in the concentration of estrone-3-glucuronide and the ratio of estrone-3-glucuronide to pregnanediol-3 alpha-glucuronide as determined by immunochemical tests on daily samples of early morning urine). The values were compared with a period of probable fertility (day of urinary luteotropin [LH] peak -3 to day of LH peak +2). The duration of the possible fertile period by each method (mean +/- standard deviation) was 13.4 (2.9), 11.9 (2.9), 11.8 (3.3), 9.3 (2.2), and 10.9 (2.3) days, respectively, while the percentage of the probable fertile periods covered entirely by each approach was 98%, 91%, 90%, 83%, and 84%, respectively. The results warrant the initiation of clinical trials to ascertain the practical value of the individual or combined tests for family planning and the management of infertility.
Physicians who counsel women for preconception concerns are in an excellent position to give advice to couples regarding the optimal timing of intercourse to achieve pregnancy. The currently available evidence suggests that methods that prospectively identify the window of fertility are likely to be more effective for optimally timing intercourse than calendar calculations or basal body temperature. There are several promising methods with good scientific bases to identify the fertile window prospectively. These include fertility charting of vaginal discharge and a commercially available fertility monitor. These methods identify the occurrence of ovulation clinically and also identify a longer window of fertility than urinary luteinizing hormone kits. Prospectively identifying the full window of fertility may lead to higher rates of conception. Proper information given early in the course of trying to achieve pregnancy is likely to reduce time to conception for many couples, and also to reduce unnecessary intervention and cost.
An analysis was made of postcoital tests carried out on 423 couples attending the Rotunda and St. James Hospitals in Dublin. Initially 66.6% of tests were abnormal, but 21.3% of these were invalid because of the presence of seminal or cervical abnormalities, leaving 57.7% of couples with initially valid negative tests. Retesting showed 30.3% of couples to have persistently negative tests, 24.5% of whom achieved pregnancy. Three per cent of abnormalities were immunologic in origin. The most common cause why a subsequently positive test was initially negative was failure to observe correct clinical procedures, but unadmitted psychosexual problems were present in 17.6% of cases. Of the best postcoital tests, 78.5% correlated well with semen analyses and 90.9% with basal body temperature charts. In total, 6.2% of all pregnancies achieved in the clinics followed postcoital testing.
Cervical mucus is a complex secretion produced by the endocervical epithelium. A comparative analysis of 30 enzymes was carried out on 15 women during their periovulatory period (days 10 to 16 of the menstrual cycle). Nine different enzymes were always found to be present in the cervical mucus. Changes in enzymatic activity were further studied in two of the women, one with a normal (27-day) and the other with a short (20-day) menstrual cycle. The data were compared with those for the same enzymes in the saliva of these two women. Each woman's ovulation time was determined through hormone measurements in urine and blood, as well as by recording basal body temperature and by Billing's method. Our results indicate that a maximum peak occurs for several enzymes during the periovulatory period.
The identification of the human fertile phase as the time during which a woman or a couple may conceive is elusive. The fertile time depends on many factors in each individual menstrual cycle and may be said to be more of a statistical than a physiological entity. This paper reviews the application of statistical methods to three areas related to conception and the fertile phase. The first is the prediction and detection of ovulation from serial measurements, such as hormones, basal body temperature and cervical mucus, throughout the menstrual cycle. Typically, such variables increase from some baseline level to a peak around ovulation (the most fertile time), then subside to low levels in the postovulatory phase. The statistical challenge is to detect the rise (signalling the onset of potential fertility) and subsequent fall. Analytic methods considered include thresholds, Bayesian change-point models and particularly the cumulative sum (cusum) technique which is both simple to apply and understand, and effective. The second area comprises appropriate methods of analysing and interpreting data from clinical studies of the fertile phase, especially in so-called natural family planning (NFP) where it is usual for women to observe several indices of potential fertility. Such studies usually try to establish the temporal relationships between markers of the fertile phase and examine the success of different combinations of markers in delineating the fertile time in comparison with a standard 'defined' phase, for example, the interval from three days before to two days after the peak of luteinizing hormone. The third area is the assessment of the probability of conception on certain days of the cycle, which is vital to the understanding of the fertile phase and its application to NFP. Direct estimation of such probabilities is impractical; instead, resort must be made to estimation by maximum likelihood of the parameters of specially constructed models. Suitable models are described. Finally, the need for a new prospective study of the probability of conception in relation to the markers of the fertile phase used in the symptothermal method of NFP is discussed.
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. REVIEWERS' 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.
The rhythm method (safe period) is the only contraceptive method which is approved and actively promoted by the Roman Catholic Church. It therefore holds and attraction to a large number of followers. This paper reviews the historical development of the method from the initial efforts in the nineteenth century to the work of Ogino and Knaus, and covers the variations which are based on alteration of the basal body temperature and changes in cervical mucus. Although this method should be devoid of side effects, certain risks have been reported due to the possible fertilization of an overripe ovum. There may also be a higher risk of ectopic pregnancy than normal to users of this method and these reports are reviewed. The results of field trials concerning the use effectiveness of the method are also examined.
A series of 110 therapeutic donor insemination cycles was analyzed to determine the impact on fecundity when a urinary luteinizing hormone detection kit was used to plan inseminations. To prevent the transmission of human immunodeficiency virus, frozen semen, thawed after a 90-day quarantine, was used. The minimum standard for insemination with cryopreserved semen was a total of 24 x 10(6) motile sperm per milliliter after thawing. Fecundity was 0.12 when insemination timing was based on cervical mucus evaluation and basal body temperature charts and 0.13 when a urinary luteinizing hormone kit was also used to predict ovulation. Life table analysis with the log rank test showed no statistically significant difference in the number of cycles required to achieve conception between the group of patients using conventional methods of ovulation timing and the group of patients using the urinary luteinizing hormone kit. Urinary luteinizing hormone testing offers no advantage over conventional methods, such as cervical mucus examination and evaluation of basal body temperature, when ovulation is being timed for insemination with frozen donor semen.
Early methods of natural family planning (calendar rhythm, basal body temperature, and symptothermal) are briefly mentioned and dismissed as unsatisfactory for fertility regulation at our present state of knowledge of female reproductive physiology. Cervical mucus patterns, which reflect ovarian hormone levels, are shown to be accurate markers of the fertile and infertile phases of a woman's menstrual cycle. Interpretation of these patterns forms the basis of the Billings Ovulation Method of natural family planning. Extensive laboratory and clinical studies have shown this method to be on a sound scientific footing, that it is applicable to all phases of a woman's reproductive life, and that women readily understand and are able to teach other women the meaning of these patterns as experienced by changing sensations at the vulva and changing characteristics of any visible mucus. The simple rules which have been formulated for postponing and achieving pregnancy are given. Field trials of this non-invasive method for fertility regulation in both developing and developed countries show that the rules are readily understood by participants. In the most recent trials, it has been shown that the method-related pregnancy rate is less than 1 per 100 woman years, which compares more than favorably with other contraceptive techniques.