Protocol for Determining Fertility While Breastfeeding and Not in Cycles

A protocol was developed and evaluated for nonovulating breastfeeding women to determine potential fertility with an electronic hormonal fertility monitor. The amount of required abstinence (i.e., days of potential fertility) through the first menstrual cycle indicated by the fertility monitor was significantly lower (17% of the total days) compared with the amount of abstinence (50% of the total days) indicated by the self-observation of cervical mucus

Efficacy of the Marquette Method of Natural Family Planning

Purpose: To determine the effectiveness of the Marquette Method (MM) of natural family planning (NFP) as a method of avoiding pregnancy. Study Design and Methods: This was a 12-month retrospective evaluation of the MM system of NFP. Two hundred and four women (mean age, 28.6 years) and their male partners (mean age, 30.3 years) who sought to learn a method for avoiding pregnancy with the MM from four clinical sites were taught to track their fertility by self-observation of cervical mucus, by use of an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone, and by use of basal body temperature. All unintended pregnancies were evaluated by professional nurses as to whether they were intended or not. Pregnancy rates over 12 months of use were determined by survival analysis. Results: There were a total of 12 unintended pregnancies, only 1 with correct use. The 12-month “correct use” pregnancy rate was 0.6 (i.e., 99.4% effective) and the “typical use” (total pregnancy rate) was 10.6 (i.e., 89.4% effective) per 100 users. Clinical Implications: When used correctly, the MM system of NFP is an effective means of avoiding pregnancy. The efficacy of the MM system includes proper preparation of the professional nurse NFP teachers

Effectiveness of a Natural Family Planning Service Program

Purpose: The aims of this study were to determine and compare extended use-effectiveness of an online nurse-managed fertility education service program among women (and subgroups of women) seeking to avoid pregnancy. Study Design and Methods: This was a 24-month prospective study of a university-based online Web site with 663 nonbreastfeeding women using an online charting system to avoid pregnancy. Participants tracked their fertility online with either cervical mucus monitoring, electronic hormonal fertility monitoring, or both fertility indicators. Unintended pregnancies were validated by professional nurses. Results: Participants had a mean age of 30.4 years (SD = 6.3) and mean 1.7 children (SD = 2.0). Among the 663 nonbreastfeeding participants there were 2 unintended pregnancies per 100 at 24 cycles of correct use and 15 pregnancies at 24 cycles of typical use. However, the 212 women using the electronic fertility monitor had a typical use unintended pregnancy rate of 6 at 24 cycles of use in comparison with the 118 women using cervical mucus monitoring that had a typical use pregnancy rate of 19 at 24 cycles and with the 333 women using both fertility indicators that had a pregnancy rate of 18 at 24 cycles of use. Clinical Implications: Use of the fertility monitor to estimate fertility among nonbreastfeeding women provides the most secure method of avoiding pregnancy

Variability in the Hormonally Estimated Fertile Phase of the Menstrual Cycle

The purpose of this study was to determine the variability in length of the fertile phase of the menstrual cycle with 140 participants who produced 1,060 cycles with an electronic hormonal fertility monitor. The length of the fertile phase, as defined by the first day with a threshold level of urinary E3G and ending with a second day above a threshold of LH, varied from7 days, with the most frequent length being 3 days

Executive Summary: Randomized Comparison of Two Internet-Supported Methods of Natural Family Planning

Only 0.2% of US women use modern methods of natural family planning, i.e., the basal body temperature and the cervical mucus methods of natural family planning (NFP). The reason that such few women use NFP methods is because they are often ineffective, they are difficult to use, there is lack of access to properly trained NFP teachers, a lack of motivation to use a behavioral method, and health professionals are reluctant to prescribe NFP methods. One way to potentially increase the use of NFP methods is to provide easy access to an effective but simplified NFP method that uses a hand held electronic hormonal fertility monitor (EHFM), an internet based charting system, and online professional support. Mutual motivation is recognized as essential for effective behavioral methods of family planning. Few studies have studied this factor in family planning efficacy

Randomized Comparison of Two Internet-Supported Natural Family Planning Methods (Preliminary Findings)

The aims of this study were to determine and compare efficacy, satisfaction, ease of use, and motivation in using an internet-based method of Natural Family Planning (NFP) that utilizes either electronic hormonal fertility monitoring (EHFM) or cervical-mucus monitoring (CMM). Four hundred fifty women (mean age 30.1) and their male partners (mean age 31.9) who sought to avoid pregnancy were randomized into either an EHFM (N=228) or CMM NFP group (N=222). Both groups utilized a Web site that provided NFP instructions, an electronic charting system, and support from professional nurses. Participants were assessed for satisfaction, ease of use, and motivation in use of their respective NFP method at 1, 3, and 6 months. Unintended pregnancies were validated by pregnancy evaluations and urine tests. Correct and total pregnancy rates were determined by survival analysis. Correct and total 12 month unintended pregnancy rates for the combined participants (N=450) were 1 and 9 per 100 couple users (Std. Error = .01 and .02) respectively. The EHFM participants (N=228), however, had a typical unintended pregnancy rate of 6 (Std. Error = .03) compared to the CMM group (N=222) pregnancy rate of 13 (Std. Error = .04) per 100 users over 12 months of use. The mean satisfaction/ease of use score for the EHFM group at 6 months of use was 46.1 compared to 42.9 for the CMM group (p \u3c .07). Motivation to avoid pregnancy was stronger for the CMM group compared to the EHFM group at 3 and 6 months of use (37.9 and 38.8 versus 33.7 and 33.4, p \u3c .01). Although both NFP methods were highly effective methods of family planning delivered through a nurse supported Web site, at this time, the unintended pregnancy rate was lower for the EHFM group and compared well with hormonal contraception. Although acceptability of the EHFM NFP was high, motivation to avoid pregnancy with that group decreased over time

Final Report: Randomized Comparison of Two Internet-Supported Methods of Natural Family Planning

Studies consistently show that women want safe, effective, easy to use, and convenient methods of family planning (Arévalo,1997; Severy 2001). Although Natural Family Planning (NFP) methods are free of side effects, they are often ineffective and complex to learn and use (Grimes et al. 2005). Efforts have occurred over the past 10 years to simplify the teaching and use of NFP methods and increase their efficacy. These efforts include the development of low tech calendar-based methods (Arévalo et al. 2004), simplifying instructions (Frank-Herrmann et al. 2005), and developing accurate biological markers of fertility (Guida et al. 1999). A new high-tech electronic method to monitor fertility has recently been developed to help women determine their fertile window with ease, convenience, and accuracy (May 2001). This high-tech electronic hormonal fertility monitor (EHFM), called the ClearBlue Easy Fertility Monitor (Swiss Precision Diagnostics), measures urinary metabolites of estrogen and LH and provides the user with a daily indication of “low,” “high” and “peak” fertility. A recent cohort study demonstrated that EHFM was effective when used as an aid to avoid pregnancy along with cervical mucus monitoring (CMM) as a second marker of fertility (Fehring, et al., 2007) and users reported high satisfaction with the method (Severy et al. 2006).Despite this promising research, there is one task that has not yet been accomplished. There are no randomized comparison studies of EHFM NFP methods with NFP methods that utilize traditional biological markers of fertility (i.e., the Ovulation Method with cervical mucus monitoring and/or the symptom-thermal method with basal body temperature and cervical mucus monitoring combined). Other recent efforts to increase the ease of use and convenience of NFP methods are the use of internet support for NFP instructions and automated online fertility charting (Fehring 2004; Fehring 2005; Weschler 2005). Although there have been studies to determine the knowledge base of an online hormonal contraceptive program, there have been only one pilot study to determine the efficacy of internet-based instructions for NFP methods used to avoid pregnancy (Kaskowitz et al. 2007; Fehring et al., 2011) and to determine the efficacy and satisfaction of using an online fertility charting system for NFP purposes (Fehring, et al., 2011)

Efficacy of Cervical Mucus Observations Plus Electronic Hormonal Fertility Monitoring as a Method of Natural Family Planning

Objective: To determine the effectiveness of an electronic hormonal fertility monitor plus cervical mucus monitoring to avoid pregnancy. Design: A 12-month prospective clinical efficacy trial. Setting and Participants: One hundred ninety five (195) women (mean age 29.8 years) seeking to avoid pregnancy with a natural method at 5 clinical sites in 4 cities. Intervention: Each participant was taught to track fertility by self-observation of cervical mucus and an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone. Main Outcome Measures: Correct-and typical-use unintended pregnancy rates. Results: There were a total of 26 unintended pregnancies, 3 with correct use. With 1,795 months of use, the correct-use pregnancy rate was 2.1% per 12 months of use (i.e., 97.9% effective in avoiding pregnancy when rules of the method were always followed) and the imperfect-use pregnancy rate was 14.2% per 12 months of use (i.e., 85.8% effective in avoiding pregnancy when rules of the method were not always followed and all unintended pregnancies and months of use were included in the calculations). Conclusions: Correct use of an electronic hormonal fertility monitor with cervical mucus observations can be as effective as other fertility awareness–based methods of natural family planning. Comparative studies are needed to confirm this conclusion

Efficacy of a New Postpartum Transition Protocol for Avoiding Pregnancy

Introduction: The postpartum period is a challenging time for family planning, especially for women who breastfeed. Breastfeeding delays the return of menses (lactational amenorrhea), but ovulation often occurs before first menses. For this reason, a protocol was developed to assist women in identifying their return of fertility postpartum to avoid pregnancy. Methods: In this prospective, 12-month, longitudinal cohort study, 198 postpartum women aged 20 to 45 years (mean age, 30.2 years) were taught a protocol for avoiding pregnancy with either online or in-person instruction. A hand-held fertility monitor was used to identify the fertile period by testing for urinary changes in estrogen and luteinizing hormone, and the results were tracked on a web site. During lactational amenorrhea, urine testing was done in 20-day intervals. When menses returned, the monitor was reset at the onset of each new menstrual cycle. Participants were instructed to avoid intercourse during the identified fertile period. Kaplan-Meier survival analysis was used to calculate unintentional pregnancy rates through the first 12 months postpartum. Results: There were 8 unintended pregnancies per 100 women at 12 months postpartum. With correct use, there were 2 unintended pregnancies per 100 women at 12 months. Conclusion: The online postpartum protocol may effectively assist a select group of women in avoiding pregnancy during the transition to regular menstrual cycles

Variability in the Phases of the Menstrual Cycle

Objective: To determine variability in the phases of the menstrual cycle among healthy, regularly cycling women. Design: A prospective descriptive study of a new data set with biological markers to estimate parameters of the menstrual cycles. Participants: One hundred forty one healthy women (mean age 29 years) who monitored 3 to 13 menstrual cycles with an electronic fertility monitor and produced 1,060 usable cycles of data. Measures and Outcomes: Variability in the length of the menstrual cycle and of the follicular, fertile, and luteal phases, and menses. The estimated day of ovulation and end of the fertile phase was the peak fertility reading on the monitor (i.e., the urinary luteinizing hormone surge). Results: Mean total length was 28.9 days (SD= 3.4) with 95% of the cycles between 22 and 36 days. Intracycle variability of greater than 7 days was observed in 42.5% of the women. Ninety-five percent of the cycles had all 6 days of fertile phase between days 4 and 23, but only 25% of participants had all days of the fertile phase between days 10 and 17. Conclusions: Among regularly cycling women, there is considerable normal variability in the phases of the menstrual cycle. The follicular phase contributes most to this variability