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.
 
References:

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.

• Peak circulating levels of estradiol in menstruating women = 400 pg/ml (pg = picograms per milliliter of blood).  
• Most pills today have 35 µg of EE2. (µg = micrograms per pill) Note: 1 µg = 1,000,000 pg.
• After a pill is ingested, about 50-60% of it passes through the gut and is excreted in the urine and feces. Blood levels of EE2 in women taking this dose are less than 58 pg/ml within 1 hour of taking the pill. Therefore, most of the remaining EE2 (~6,900 pg/ml) is excreted into the wastewater, every day the pill is taken.
• The number of women on hormonal contraception in the U.S. = 9 million. Note: another 743,660 women are on implantable contraception and are not included in this calculation.
• If a conservative estimate of 50% of the EE2 is excreted by nine million women, that would be 157 million µg of EE2 per day (17.5 µg x 9 million) Note: this is the same as 157 grams per day.
• The degradation of EE2, once it is in the dark and anaerobic conditions of the water supply, is slow. In these conditions the half-life is at least 100 days (Adeel et al., 2017).  Note: If 78.5 grams (1/2 of 157 grams) of EE2 is degraded in 100 days, the estimated loss is 0.78 grams per day.
• Therefore, each day, 0.78 grams are degraded, but another 157 grams are added into the water supply of the United States. The volume of water that it flows into and the amount of tainted water consumed would then determine the dose that an exposed person would receive.

               
          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.

References

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.
https://www.cdc.gov/nchs/products/databriefs/db327.htm

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
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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.

Impact

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
Email: Joseph.Turner@une.edu.au
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.

We just learned that Dr. Erik Odeblad of Sweden died on October 17, 2019. Pictured on the right with Drs. John and Lyn Billings, Dr. Odeblad became a close friend and collaborator of the Billings over the years. Best known for his remarkable discoveries of the properties of cervical mucus, Dr. Odeblad leaves us a legacy of significant research that also includes the purpose of the Pockets of Shaw and their role in identifying Peak Day,  among other discoveries. We will feature him in our November newsletter. 

BOMA-USA Exhibit at Catholic Medical Association Conference Was Inspirational

By Martha Winn, RN, BOMA-USA Education Chair

The Catholic Medical Association (CMA) is a national organization providing support and education to the Catholic health professional. Presently there are 104 physician “guilds” across the country. The local guild helps the healthcare professional stay up-to-date about issues of health care in their community/state and to build a network of support.

The CMA conference this year took place in Nashville, TN at the beautiful Opryland Hotel. Close to 900 physicians, health professionals, medical students, residents, clergy, and religious attended to gain Continuing Medical Education credits, pray, and enjoy fellowship. BOMA-USA was represented by a table of information in the exhibitor’s hall in the Tennessee Ballroom. The BOMA-USA banner is attractive with the words, “Pure and Simple!”. During the conference, I was pleased to “spread the word” with brochures, books, and information. Equally rewarding was the opportunity to shake hands with the many friends and supporters of the Billings Ovulation Method®.

The theme of this year’s conference was “Physician, Heal Thyself: Living the Fulfilled Life in Medicine”. The theme is a timely topic. I spoke to professionals from varied disciplines who discussed recent trends in medicine. The Catholic Church’s teaching on life from conception to natural death is central to the practice of their medicine. Our culture is often rife with confusion on the issue of life. This conference offered sessions addressing the concerns of the healthcare professional who is battling these issues daily. The professional must take care of their own personal needs in order to take care of others, including spiritual care. Sacramental confession, Mass, and Adoration were a large part of the conference.

I gave a presentation for one of the breakout sessions. My talk was entitled, “Fertility Awareness Method Management Education in Medical Practices: Empowering Patients to Participate in Care/Simplifying the Office Visit”. I discussed how to incorporate the fertility awareness information in a practice with the use of certified teachers as an allied health team member. Proper education of the patient will save time during the 10-minute office visit and in many cases will allow a more effective treatment plan. I included statements from a survey of professionals who are currently including the education in their practice to demonstrate effectiveness.

My respect and admiration for the CMA has grown by attending the conference. It is an encouragement to see a growth of practices offering fertility education. Credit is given to the CMA for this trend. For more information, access their website, https://www.cathmed.org/

Billings Fellowship Hour

In an effort to give more value to our treasured members, and as a way to connect teachers and other members throughout the country, we are announcing our new Billings Fellowship Hour.

It will be a free, members-only Zoom meeting which can be accessed on a computer or other device through a simple internet link. We will encourage video participation so that we will be able to see each other, react, and ask questions. It should be great fun! The plan is to offer the special hour each month on varying days and times.

The first Billings Fellowship Hour will be on Sunday, October 27 at 7 pm Central Time. Fr. Joe Hattie, O.M.I. of Barry’s Bay, Ontario, Canada will be our first guest. Fr. Hattie is the Spiritual Director for WOOMB International. A longtime friend of Drs. John and Lyn Billings, Fr. Hattie was a frequent participant at WOOMB conferences in Australia over the years. He will discuss a document he wrote called, “Spiritual Direction for Billings Ovulation Method Teachers.” Participants will hear his fascinating advice on how the devil can tempt us with good things that others are capable of doing instead of us in order to keep us from our Billings work.

To register for the October 27 meeting, please email sue@boma-usa.org. In addition, please share with Sue any ideas for future guest speakers or topics, as well as suggestions for days of the week and times that you prefer to have the Fellowship Hour.

By Craig Turczynski, Ph.D.

BOMA is getting the word out! Over the last few weeks, we have attended the FACTS meeting, completed our first healthcare student training initiative, produced our first podcast, and recorded a marketing interview for Catholic Radio in Dallas.

Attending the FACTS meeting in Dallas on Oct. 12 was very valuable. Bernadette May, RN and I shared responsibility for our display table with Alana Newman. Alana is one of our certified teachers and the star of Springtime Production’s documentary “Sexual Revolution: 50 Years Since Humanae Vitae”. This film does a suburb job of profiling John and Evelyn Billings and we had it playing on screen at our booth. It is available on our website for sale. The booth traffic was very good, especially after Dr. Mary Martin gave her talk. We are grateful for how well Dr. Marguerite Duane balanced the presentations for all the methods, but we were especially proud of the final presentation given by Dr. Martin.

In collaboration with FACTS, we trained six healthcare students to teach the Billings Ovulation Method®. It was a combined effort by Martha Winn, RN, and Tony and Marianne Abadie. This was the first group to be trained as part of our Capital Campaign effort, for which we are actively fundraising. We are finalizing the way this training will be offered along with the budget and process for scholarships, which makes this first effort very helpful. Cooperation with other organizations is key to expanding our reach. If you would like to donate, click on the following link https://www.boma-usa.org/donate2.html.

Our very first “members-only” podcast was recorded and put on the website in October entitled “PCOS - Getting to the Root Cause”. You can access it on the new members resources page here https://www.boma-usa.org/401/login.php?redirect=/member-resources.html . It is password protected, so be sure to have your members password handy to access it. If you don’t remember what this is, please e-mail Sue Ek, Sue@BOMA-USA.org and she will provide this key requirement. We had the honor of interviewing Dr. Danielle Koestner, DO, about how she uses the Billings Ovulation Method® in her practice with a special emphasis on PCOS.
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Finally, I got the opportunity to record an interview for Catholic Radio in Dallas. Our primary purpose is to get the word out about our health care student training effort and gain financial support. This will air as the KATH 910 AM “Interview of the Week” by Dave Palmer on Saturday, November 2nd beginning at approximately 3:30pm. It will also be on the Guadalupe Radio Network app after November 2nd, which can be found online at www.grnonline.com. You can also listen to it at your leisure by clicking on this link Craig Turczynski interview here.