Fertility Awareness-Based Methods for Women's Health and Family Planning.

In the last decade there has been an explosion in the number of fertility apps for smart phones and other mobile devices, available for women to track their cycle, with more than 500 apps available via Google and the Apple app store when using the keyword fertility to search for apps ( 6 ). Although many apps claim to be useful for avoiding or achieving pregnancy, a 2016 systematic review of apps marketed for avoiding pregnancy demonstrated that the large majority are not concordant with evidenced-based methods of fertility awareness. The few apps that were rated highly were associated with established FABM methods (see Table 1 ) ( 5 ). Similar results were reported in a 2020 scoping review, namely that few apps accurately predict the fertile window ( 108 ). To date, two apps, Natural Cycles and Clue, the former based primarily on basal body temperature, and the latter using the dynamic optimal timing (DOT) algorithm, have received FDA clearance for use as a contraceptive device ( 99 , 100 ). Both apps support an approach of FABM combined with barrier methods, as they stipulate that correct use includes the possible use of barrier methods on fertile days. One app interprets urine estrogen metabolites and LH to define the fertile window, and has been shown effective for trying to conceive (see Table 4 ) ( 72 ). Additional apps are available or being developed that may integrate artificial intelligence to interpret hormones or metabolites in urine, including estradiol, LH, and progesterone, but as yet there is no published research on their effectiveness to avoid pregnancy or to conceive ( 109 ).

The concomitant use of barrier methods (e.g., condoms) or withdrawal during fertile days may influence pregnancy rates, in comparison to abstinence from genital contact during the fertile window. There are a few studies that have examined this question systematically. In a study of the Standard Days Method ( n = 373), the correct use pregnancy rate with abstinence in the fertile time was 4.8% at 1 year, while the correct use pregnancy rate including barriers or withdrawal during the fertile time was 5.7% ( 96 ). Similarly, in a study of the TwoDay Method ( n = 450), the correct use pregnancy rate with abstinence in the fertile time was 3.5%, while the correct use pregnancy rate including barriers or withdrawal during the fertile time was 6.3% ( 95 ). In a study of 900 women using Sensiplan, the 13-cycle cumulative typical use pregnancy rates were 1.6% for Sympto-Thermal only, and 2.0% for occasional use of barriers in the fertile time ( 88 ). Overall, these data do support the logic that use of a barrier method or withdrawal during a fertile day should be expected to have at least a slightly higher chance of pregnancy than no sexual contact during that same fertile day.

Women's interest in learning to track their menstrual or reproductive cycle has increased dramatically over the last couple of decades, both for health monitoring and family planning purposes ( 1 – 3 ). This interest has been paralleled and fueled by the development of over 500 mobile health applications intended for cycle tracking, more than triple the number from only 5 years ago ( 4 – 6 ). By working with trained instructors or via other educational programs, women can learn how to track their cycles and observe specific external signs or biomarkers that reflect normal and abnormal hormonal patterns and reproductive function ( 7 , 8 ). Women or couples can also use this information for family planning purposes ( 9 , 10 ). The purpose of this review is to provide an overview of current evidence about fertility awareness-based methods (FABMs) in the context of women's health, and for achieving or avoiding pregnancy. Historically, FABMs were most commonly referred to as natural family planning (NFP), which is defined by the World Health Organization as “methods for planning for avoiding pregnancies by observation of the natural signs and symptoms of the fertile and infertile phases of the menstrual cycle” ( 11 ). Some couples combine their knowledge of the fertile and infertile phase with the use of other methods during the fertile phase, such as barrier methods or withdrawal ( 12 ). As discussed later in this paper, we refer to this as FABMs combined with other methods. The term fertility awareness-based methods highlights that these methods may be used for more than family planning purposes and in recent decades, there has been additional focus on the value of using this information for medical evaluation and treatment ( 7 , 8 , 13 , 14 ). The menstrual cycle is increasingly recognized as a vital sign of health that women should have the opportunity to learn to monitor beginning in adolescence ( 15 ). Just as with other vital signs pointing to disease states, recognition of variations in menstrual patterns can improve early identification of potential health concerns that could become more severe if a timely diagnosis and appropriate treatment are not made ( 7 , 15 , 16 ). With most FABMs, women track vaginal bleeding and patterns of cervical fluid secretions and/or other biomarkers of health or fertility, such as basal body temperature (BBT) or urinary hormone measurements. Most FABMs employ a paper or electronic chart, which serves as a daily diary of the woman's own observations. Paradoxically, however, only 4% of physicians have received any formal training in FABMs ( 17 ). In addition, only 6% of physicians have correct knowledge about the perfect and typical use effectiveness of FABMs to avoid pregnancy ( 18 ). Without formal training in reading the female reproductive cycle chart, physicians and other clinicians may miss important information about this vital sign of health when providing care to their patients. This article discusses FABMs that are frequently used in North America ( Table 1 ), resources for clinicians to learn about FABMs, the role of FABMs in understanding women's health, and the effectiveness of FABMs for achieving or preventing pregnancy. Our intent is to provide information that physicians and other clinicians can use to guide patients who may benefit from learning FABMs. We also aim to provide information to clinicians about how FABMs can help with diagnosis and treatment of women's health conditions, including common conditions underlying female subfertility. Overview of fertility awareness-based methods (FABMs). Biomarker abbreviations: CF, cervical fluid; BBT, basal body temperature; CAL, calendar calculations based on cycle length and/or prior days of ovulation; uLH, urine LH tests; uE, urinary estrogen metabolites. Parentheses indicate optional additional biomarker . Apps or web applications were included if they followed the same guidelines for identifying the fertile window as the FABM method they represent ( 5 ), but only those apps marked with + been directly evaluated for pregnancy prevention . These similar methods have no peer-reviewed evidence for effectiveness for pregnancy prevention among their own users . In pregnancy prevention effectiveness studies of the Billings, Creighton, Sympto-Thermal Method and in most studies of the Marquette method, couples learned the method from a trained instructor . Sensiplan—sympto-thermal method with the strongest evidence base, but with limited availability in the US .

The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government.

There are several ways that FABMs can be used to enhance medical evaluation and treatment for women. (1) Women's observations on the FABM chart may suggest the presence of conditions that need further evaluation with diagnostic studies ( Table 2 ). (2) Identifying the time of ovulation facilitates the scheduling and interpretation of time sensitive evaluations. For example, progesterone levels are very low prior to ovulation, and are normally at a maximum level 5–8 days following ovulation. Identifying ovulation allows the measurement of progesterone when it should be at its highest level ( 8 ). (3) Chart patterns may reflect intermediate outcomes from different types of fertility treatments. For example, a change from anovulatory to ovulatory cycles will be reflected in the woman's observation of her ovulation indicators ( 35 ). Integrated medical evaluation and management protocols based on FABMs have been developed to address many women's health conditions that are related to the menstrual cycle, including subfertility or infertility. Natural Procreative Technology (also known as NaProTechnology) is a set of evaluation and treatment protocols developed based on women charting with the Creighton Model FertilityCare System ( 8 , 45 ). It includes medical and surgical components. The Reproductive Health Research Institute (RHRI) has also published a set of medical evaluation and treatment protocols for women's health conditions, which are often related to FEMM (Fertility Education and Medical Management), but can also be used with any FABM that identifies ovulation accurately ( 7 , 35 , 60 ). A detailed or critical review of the components of each of these protocols is beyond the scope of this article; however, several resources for continuing medical education in FABMs are now available (see Table 3 ). Continuing medical education (CME) resources for medical applications of fertility awareness-based methods. RHRI medical protocols may be used in conjunction with any FABM that tracks ovulation (e.g., Billings, Creighton, FEMM, STM) .

To maximize effectiveness of any FABM, it is important that people receive adequate instruction, which clearly identifies biomarkers of interest and how they may be tracked to understand fertility. We believe this is particularly true for using FABMs in medical applications. To date, most studies of FABMs to avoid pregnancy or to conceive have delivered this instruction via trained teachers, usually in person ( 9 ). More recently, online models of instruction have proven effective for some methods ( 102 ). Some simpler methods have delivered their instruction through online resources, such as videos ( 11 , 99 , 100 ).

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FABMs arise from an understanding of how the normally functioning reproductive age female produces observable external biomarkers, or ovulation indicators, that reflect internal hormonal changes. Figure 1 illustrates the relationship between a female's reproductive organs, hormones, and cyclic changes in ovulation indicators, including cervical mucus or fluid secretions, luteinizing hormone (LH), and basal body temperature (BBT). The uterine cervix plays a key role in producing the different types of cervical fluid that perform important functions related to sperm storage, transport and fertilization ( 19 – 21 ). Changes in cervical fluid, LH and BBT are each useful to identify the occurrence and timing of ovulation, which is usually the central event of the menstrual cycle ( 22 ). Physiologic changes of the female cycle. Although the onset of menses is used to identify the beginning of the cycle, the menstrual bleed, or “menstrual period,” actually marks the end of the previous ovulatory cycle. Then, under the influence of gonadotropin-releasing hormone, the pituitary secretes follicle stimulating hormone (FSH) in the follicular phase ( 7 , 13 ). Rising levels and changes in pulse frequency of FSH stimulate the growth of ovarian follicles that produce estradiol and related hormones ( 7 , 13 ). In addition to building up the endometrium, estradiol also acts on crypt cells in the cervix, which results in the production of fertile type E cervical mucus, which is clear, stretchy, and/or slippery in sensation ( 13 , 22 – 24 ). When estradiol rises and reaches a threshold, mid-cycle, it triggers a luteinizing hormone (LH) surge that results in ovulation ( 7 , 13 , 25 ). Ovulation only occurs on 1 day in each cycle and the ovum or ova will survive <12–24 h if not fertilized ( 7 , 25 ). Type E cervical fluid produced under the influence of estradiol in the peri-ovulatory period is critical for the effective transport, nurturing and survival of sperm ( 22 , 23 , 26 ). The last day of fertile type E cervical fluid, designated the mucus peak day, is a good external marker, as ovulation occurs within 2–3 days of the mucus peak day 87–98% of the time ( 23 , 26 , 27 ). After ovulation, the luteal phase begins. The ruptured follicle transforms into the corpus luteum and begins to secrete progesterone and estradiol ( 7 , 28 ). The secretion of progesterone causes the cervical fluid to become thick and impermeable (Type G or gestagenic cervical fluid), and results in a change in sensation, typically causing dryness ( 21 – 23 , 29 ). Progesterone also increases the metabolic rate and leads to a rise in the basal body temperature (BBT) ( 7 , 12 ). Finally, progesterone also converts the endometrium from proliferative to secretory to prepare for possible implantation. In the case of implantation of an embryo, human chorionic gonadotropin (hCG) is produced, which stimulates the ovary to continue producing progesterone and estradiol ( 30 ). If implantation does not occur, in the absence of hCG, the corpus luteum atrophies and progesterone levels drop, which results in the shedding of the endometrial lining (menstruation) and the next cycle begins ( 7 , 25 ). With regard to cycle lengths, the follicular or preovulatory phase is inherently more variable than the luteal or postovulatory phase ( 31 , 32 ). When considering past cycle lengths and prior estimated ovulation dates, it is possible to use evidence-based calendar formulas to estimate the start and end of the fertile window; however, calendar formulas are not precise enough to provide reasonable estimates of the day of ovulation. It must be emphasized that most calendar formulas in popular use, and even in most apps, are oversimplified, not individualized, and are not evidence-based ( 5 , 33 ). Broadly, there are six different types or categories of FABMs, based on the biomarkers or fertility indicators that are used to identify ovulation and the fertile window (see Table 1 for overview of the types and the indicators used for each). These include cervical fluid (mucus) methods, BBT methods, urinary hormone methods, sympto-thermal methods, sympto-hormonal methods, and calendar-based (i.e., cycle length-based) methods. Finally, the lactational amenorrhea method is an effective natural method that a woman may use within the first 6 months post-partum as long as she has not had a return of menses and her baby is breastfeeding exclusively at the breast ( 34 ).

FABMs serve as a useful tool for people to track daily external observations that reflect ovulation and the internal hormonal changes women experience throughout their cycle. Physicians and other clinicians may learn to interpret the female cycle chart to identify potential abnormalities of the menstrual cycle and inform a differential diagnosis and management plan to address a range of reproductive health issues, such as abnormal uterine bleeding, subfertility, and other conditions associated with abnormalities in ovulation or reproductive hormone levels. When clinicians are knowledgeable about the range of FABMs and their effectiveness, they can also offer patients a wider array of options for seeking pregnancy or avoiding pregnancy (both aspects of family planning), which will meet the needs of more people. Adding FABMs to the mix of available contraceptive methods has been demonstrated to expand the proportion of women using family planning, without any increase of unplanned pregnancy rates ( 112 ). Unfortunately, most physicians are currently not well-versed in modern FABMs, the science underlying their use, or the medical applications of these methods ( 18 ). This article offers an introduction to FABMs and their medical applications for physicians and other clinicians. For more information, we encourage our colleagues to pursue continuing medical education options in restorative reproductive medicine, such as those outlined in Table 3 .

FABMs or natural methods are unique among family planning options, in the level of encouraging understanding, involvement or assent from both partners, and communication between them ( 9 , 12 , 103 , 110 ). As behavioral methods of family planning, FABMs rely on people learning to track the observable female biomarkers on a daily basis to determine whether they may be fertile and when they are not ( 9 , 12 ). They can then share this information with their partner and depending on their family planning goals follow the rules of their chosen method for preventing or achieving pregnancy ( 111 ). These methods may positively influence relationships and body literacy. One study of over 2500 sympto-thermal users found large majorities of women and men felt NFP improved their relationship and sex-life, and three-fourths of them were satisfied with how often they had sexual intercourse. Fully 95% of women reported using a natural method improved their body literacy ( 103 ).

MD serves as a paid part-time Director of the Fertility Appreciation Collaborative to Teach the Science (FACTS), a collaborative project of the Family Medicine Education Consortium. JS serves without compensation on the Boards of the International Institute of Restorative and Reproductive Medicine and the Fertility Care Centers of America. CP serves on the board of the International Board of Lactation Consultant Examiners. PV serves as the medical director of the Reproductive Health Research Institute.

This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $ $1,572,177 over 5 years with zero percentage financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government.