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The Importance of Effectiveness Studies in Fertility Awareness-Based Methods and the Medical Community
Clinical trials and research studies on Fertility Awareness-Based Methods (FABMs) are scarce, having a few published in peer-reviewed journals in 2018-19, compared to the hundreds of studies published about contraception and contraceptive methods during the same time. In September 2018, the latest and most needed systematic review on the “Effectiveness of FABMs for Pregnancy Prevention” (Peragallo Urrutia et al., 2018) was published in the Journal of Obstetrics and Gynecology. The principal investigator, Joseph Stanford, MD, was a distinguished guest at our monthly webinar series. Dr. Stanford is a professor of family medicine, pediatrics, obstetrics, and gynecology and the director of the Office of Cooperative and Reproductive Health at the University of Utah School of Medicine.
In his talk, Dr. Stanford described the general concepts of pregnancy rates (“pregnancies/cycles”), effectiveness (“1-pregnancy rate”), perfect use, typical use, achieving-related behavior, and avoiding-related behavior in the context of FABMs. He brought clarity on the often-confused terms: perfect use and typical use. He explained that “perfect use is equal to the pregnancy rate for ‘perfect’ use to avoid pregnancy and in which only the cycles with ‘correct use’ to avoid pregnancy are included,” and “typical use is equal to the pregnancy rate for ‘real-life’ conditions to avoid pregnancy, in which all the cycles to avoid pregnancy are included.”
In this systematic review, the research team wanted to answer the question: “What is the evidence of effectiveness of specific FABMs to avoid pregnancy, as measured by unintended pregnancy rates?” To address that question, they formed a multidisciplinary team, registered their protocol in PROSPERO, an international prospective register of systematic reviews, and searched databases such as MEDLINE, Embase, CINAHL, and Web of Science. Besides, they adapted 13 quality criteria and categorized their results as high, moderate, and low indicators. They initially identified 9,868 records, and after exclusions, only 53 unique studies that described 65 cohorts of specific FABMs were included. Of those, fourteen studies evaluated the Billings Ovulation Method or variants (Peragallo Urrutia et al., 2018). According to their classification, five out of 14 were of moderate quality. Of note, none of the studies included in the systematic review had a high-quality score. In the studies of moderate quality, for the Billings Method, the perfect use pregnancy rate per 100 women-years described was 1.1 (Bhargava, Bhatia, Ramachandran, Rohatgi, & Sinha, 1996) and 3.4 (Trussell & Grummer-Strawn, 1991). The lowest typical use pregnancy rate per 100 women-years described was 10.5 (Bhargava, Bhatia, Ramachandran, Rohatgi, & Sinha, 1996), and the highest pregnancy rate was 33.6 (Medina, Cifuentes, Abernathy, Spieler, & Wade, 1980).
In his talk, Dr. Stanford mentioned that the most commonly met high-quality criteria were the type of FABM used, the duration of the study, and the characterization of the population of new users. The high-quality criteria least commonly met were the evaluation of intercourse in each cycle, the close follow-up to detect pregnancy, the reproductive characteristics of the users, and the assessments of intentions for avoiding or achieving pregnancy during each cycle. Therefore, as Certified Billings Teachers and Supervisors, we may want to pay more attention to these features when evaluating clients.
Dr. Stanford’s closing recommendations of reporting all pregnancies (unintended and intended); measuring intentions and different behavioral, demographic, and reproductive characteristics; evaluating all cycles and not only the pregnancy cycles; describing unintended pregnancies as a range; assessing any use of barriers or withdrawal; etc. not only seeds the curiosity in scientists to explore further hypotheses but set the grounds for building best practices to develop meaningful research protocols that ultimately might help the Billings community, users and providers alike.
Bhargava, H., Bhatia, J.C., Ramachandran, L., Rohatgi, P., & Sinha, A. (1996). Field trial of billings ovulation method of natural family planning. Contraception, 53, 69-74.
Medina, J.E., Cifuentes, A., Abernathy, J.R., Spieler, J.M., & Wade, M.E. (1980). Comparative evaluation of two methods of natural in Columbia. Am J Obstet Gynecol, 138, 1142-7.
Peragallo Urrutia, R., Polis, C.B., Jensen, E. T., Greene, M.E., Kennedy, E., & Stanford, J.B. (2018). Effectiveness of fertility awareness-based methods for pregnancy prevention: a systematic review. Obstet Ginecol, 132, 591-604. doi: 10.1097/AOG.0000000000002784
Trussell, J. & Grummer-Strawn, L. (1991). Further analysis of contraceptive failure of the ovulation method. Am J Obstet Gynecol, 165, 2054-9.
By Craig Turczynski, Ph.D.
There is plenty of evidence that the risk of exposure to environmental estrogens is significant. For an excellent review, read Estrogeneration by Dr. Anthony G. Jay (2017). There are several potential sources of estrogen-like substances, but curiously, an examination of the literature reveals that many studies avoid even mentioning ethinyl estradiol (EE2), the synthetic estrogen found in most oral contraception. Dr. Jay of course, being an exception, begins discussing the potential risks in his first chapter. This brings up an interesting point, that our opinions and world view influence our science and how we report on it. A few other studies are also worth noting on this topic. One was published by the EPA (Zorrilla et al., 2010), reporting the effect of EE2 on spermatogenesis in the adult male rat. Treatment of male rats with EE2 did indeed result in a decrease in sperm counts in a dose-dependent manner. Also, a review of literature was published in 2017 by Adeel et al., a group from China. This group clearly seems to avoid the politically correct posture of not mentioning EE2 as a significant source of environmental estrogen. They state:
“It is worthwhile to comment on the paucity [scarcity] of data on the synthetic EE2 compared with the natural E1 and E2.”
They make a concluding statement:
“Synthetic estrogen, ethinyl estradiol, is more persistent in the environment than natural estrogens and may be a greater cause for environmental concern.”
On the other hand, they make another statement about livestock waste being the largest source of environmental estrogen, which left me somewhat perplexed. Especially since the number of cattle in the US is less than 95 million, down from 120 million in the mid 1970s (USDA-NASS, 2018) and the number of people in the US is over 300 million. This led me to do some research and data crunching which revealed something truly startling on the magnitude of the oral contraception risk. Please indulge me on the calculations below.
The accuracy of these numbers could no doubt be disputed; they are an oversimplification and an estimate. The fact remains, however, that because of the synthetic structure of EE2, it is more resistant to degradation and therefore environmental levels are increasing over time. Dr. Anthony Jay (2017) points out the fact that most estrogens are not removed during the water recycling process and filtering them out is problematic as well. Coupled with the other sources of estrogens in our environment, the chances of health-related effects are a real concern. Concentration, duration, and age of first exposure would have a profound consequence for an individual. For example, exposure during critical times of in-utero development can have a permanent influence on the normal sexual and reproductive development of a person (Hines, 2011; Kilcoyne and Mitchell, 2019). The EPA study I mentioned above (Zorrilla et al., 2010) demonstrated that an exposure of 50 µg of EE2 per kg of weight in adult male rats was enough to reduce sperm counts, and generally rats are more resistant to disease processes than humans.
In conclusion, oral contraception is a significant source of environmental estrogen. If you care about the health of people and you say you want to clean up the environment, you can’t ignore the environmental risks of hormonal contraception, regardless of your social, religious, or political position.
Adeel, M., Song, X., Wang, Y., Francis, D. and Yang, Y. (2017) Environmental Impact Of Estrogens On Human, Animal and Plant Life: A Critical Review. Environment International 99, 107-119.
Brenner, P.F., Goeblesmann, U., Stanczyk, F. Z. and Mishell, D.R. (1980) Serum Levels Of Ethinylestradiol Following Its Ingestion Alone Or In Oral Contraceptive Formulations. Contraception 22(1) 85-95.
Daniels, K. and Abma, J.C. (2018) Current Contraceptive Status Among Women Aged 15–49: United States, 2015–2017. NCHS Data Brief #327.
Hines, M. (2011) Prenatal Endocrine Influences On Sexual Orientation And On Sexually Differentiated Childhood Behavior. Front Neuroendocrinology. 32(2) 170-182 doi:10.1016/j.yfrne.2011.02.006.
Jay, A. G. (2017) Estrogeneration: How Estrogenics Are Making You Fat, Sick and Infertile. Pyrimidine Publishing. Tallahassee FL.
Kilcoyne, K.R. and Mitchell, R.T. (2019) Effect Of Environmental And Pharmaceutical Exposures On Fetal Testis Development And Function: A systematic Review Of Human Experimental Data. Human Reproduction Update 25 (4) 397-421.
USDA-NASS (2018) US All Cattle and Calves Inventory 1867-2019. https://www.nass.usda.gov/Charts_and_Maps/Cattle/inv.php
Zorrilla, L. M., K. H. Brown, L. F. Strader, and T. E. Stoker (2010). The Effects Of Ethinyl Estradiol On Spermatogenesis In The Adult Rat. EPA record 218968, https://cfpub.epa.gov/si/si_public_record_report.cfm?Lab=NHEERL&dirEntryId=218968
An Australian study published in Human Fertility demonstrated pregnancy rates of >50% in clinically infertile women and 73% in non-infertile women, without the use of ART/IVF.
Marshell et al. "Stratification of fertility potential according to cervical mucus symptoms: achieving pregnancy in fertile and infertile couples." Published online on October 29, 2019, https://doi.org/10.1080/14647273.2019.1671613 examined patient data from 17 clinics across Australia for women seeking to achieve pregnancy. A total of 384 women were followed for up to two years after being instructed to monitor their cervical mucus and to time sexual intercourse according to the Billings Ovulation Method® in order to achieve pregnancy.
Major finding 1: pregnancy rates
The majority of the cohort had been clinically infertile for >12 months, with more than half of these achieving pregnancy, including 7 out of 20 women who were previously unsuccessful with ART/IVF. Over a quarter of the study group were >35 years old and these achieved a pregnancy rate of >50% as well. Overall, 92% of pregnancies were achieved within the first 12 months.
Major finding 2: importance of cervical mucus in achieving pregnanc
The nature of mucus observations of the woman during the fertile window, particularly the peak mucus symptom, allowed stratification of women into low or high pregnancy potential groups. A favorable mucus symptom corresponded to 76% pregnancy rate, and an unfavorable mucus symptom corresponded to a 44% pregnancy rate.
Up to 1 in 6 couples are affected by infertility. “This is basic women’s physiology,” says Dr Joseph Turner from the University of New England, “and every GP should be able to advise women on how to make their menstrual cycle work for them.” This method provides a rapid, reliable, and cost-effective approach to a) achieving pregnancy and b) stratifying fertility potential so that informed decisions about delaying or bringing forward fertility investigations and management can be made to help couples achieve pregnancy sooner.
Billings LIFE with its head office in Melbourne, has been teaching an effective, evidence-based fertility awareness method for achieving pregnancy, avoiding pregnancy, and monitoring women’s reproductive health for more than 50 years.
If you would like further information, including potential interviews with women who have conceived pregnancies using this method, please contact:
Name: Dr Joseph Turner
Phone: +61-0419 143 154
The Passing of a Great Scientist and Friend of the Billings Method™
by Sue Ek
Recently, we received the news from the WOOMB International directors: “It is with deep sadness that we inform you of the death on 17th October 2019 of Professor Erik Odeblad. Of course, the sadness is for ourselves and especially for his family. We believe he will be welcomed home by his Creator and greeted joyfully by his wife and fellow collaborators in the Billings Ovulation Method® who had returned home before him.”
The WOOMB Directors went on to say, “He was a giant amongst the scientists, well known in scientific circles before he collaborated with Drs John and Lyn Billings. His work gave us so many insights into the significance of the cervix in producing the different mucus types and its role in sperm migration and survival. We join with all who give thanks for a life very well lived. We have all been privileged to be the beneficiaries of his talents.”
In addition, “Professor Odeblad was recognised as one of the founders of what we now know of as the MRI. In the 1970s he collaborated with the Drs Billings and along with Professor James Brown, provided the validation of the Billings Ovulation Method®. We give thanks for his contributions to our knowledge.”
In 1996, BOMA-USA had Dr. Odeblad as a featured speaker at our conference in St. Cloud, MN. His presence helped us attract nearly 200 people. In fact, we had to move our venue to accommodate so many people. I have a vivid memory of helping him check in to the hotel. It was unknown to me that he was a chocoholic. While I was at the front desk getting everything in order, he eagerly nudged me and pointed across the room, saying, “Sue! Sue! Chocolate!” It took me a while to realize that he wanted me to take him to one of those candy machines that raise money for charity by charging a nickel (at the time) in exchange for a chocolate mint. The restaurant had closed so this was his only source for chocolate at that late hour. It was such a funny scene, but maybe you had to be there.
Years ago, when we were still printing and mailing our newsletter called BOMA News, we collaborated on a couple of articles. In the winter 1997 issue, we printed his interesting explanation of the various types of cervical mucus and what he called “cell-to-cell communication.”
His extensive research on the properties and purpose of the various types of cervical mucus, as well as his discovery of the reason for the Pockets of Shaw, sets us apart from other Natural Family Planning methods. For example, we are confident in our three requirements for Peak Day (changing, developing pattern; ending in slippery; followed by a definite change) because of Dr. Odeblad’s discovery of the sequence of events that leads to the Pockets of Shaw being activated after ovulation. He determined that when the follicle containing the egg ruptures at ovulation and progesterone is released, the Pockets of Shaw are activated and cause a drying effect on the cervical mucus. So, it is because of his remarkable understanding of the Pockets of Shaw that we require an abrupt change from the slippery sensation in order for Peak Day to be identified.
As a devout Swedish Lutheran, his faith planned a significant role in his life as a scientist. As Marian Corkill of WOOMB said in an email, “It is our understanding that when he was required to do abortions he quit his obstetric and gynecology position at the University of Stockholm and undertook further research in physics. This led to him being appointed a Rockefeller Foundation Fellow at the University of California, Berkeley. His time at Berkeley was significant as it was here that he learned of the work in Nuclear Magnetic Resonance, the forerunner for what we know today as MRI. His contact with Nobel Laureate Bloch led him to modify a spectrometer so that he could study human cells and secretions, particularly cervical cells. His pioneering work took a long time to be publicly acknowledged but in 2012 he was awarded the European Magnetic Resonance Award which was combined to include both Basic Science and Medical Sciences.”
We will forever be grateful to God for bringing such a tremendous gift of faith and intellect to the Billings Family. May he enjoy eternal peace.
BOMA-USA provides education and training for The Billings Ovulation Method® which is a natural method of fertility management that teaches you to recognize the body's natural signs of fertility.
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