ABSTRACT
Objective: To evaluate the use of medications and surgeries in restorative medical fertility treatments and their effects on the menstrual/fertility cycle in women with difficulty conceiving.
Design: Secondary data analysis from the International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST) study, which was a longitudinal cohort study of infertile couples to assess live birth outcomes with NaProTechnology (NPT) treatment. Descriptive analysis of medical interventions used in the study. In women with endometriosis and/or PCOS, comparative analysis of cycle characteristics before vs after restorative medical fertility treatments.
Setting: Multi-site, international study in the United States (UT, NJ, MA, LA, MO, NC, VA), Canada (Toronto), United Kingdom (Leamington Spa), and Poland (Lublin).
Patients: A total of 834 couples, females ≥ 18 years old with infertility. Some analyses were restricted to 73 patients with endometriosis, 72 patients with polycystic ovary syndrome (PCOS), or 27 patients with both.
Interventions: Medications to increase cervical mucus production (e.g., guaifenesin, vitamin B6, antibiotics), ovulation (e.g., clomiphene, letrozole), hormones to support the luteal phase of the menstrual cycle (e.g., progesterone), other treatments to normalize the fertility cycle (e.g., metformin, naltrexone), or surgical interventions to restore reproductive function (e.g., laparoscopy with removal of endometriosis, or reduction of adhesions).
Main Outcome(s): Frequency of specific medications and surgeries utilized at each study site for restorative medical fertility treatment, and changes in cycle characteristics including spotting, follicular phase length, luteal phase length, quality and duration of cervical mucus secretion.
Results (preliminary): Of the 72 patients diagnosed with PCOS, a total of 46 had medication and/or surgery information and of the 73 patients diagnosed with endometriosis, a total of 53 had therapy information. Of those, there were 41 PCOS participants and 43 endometriosis participants with CrMS charts evaluated.
Progesterone was the most used medication for all participants (87.0% PCOS and 67.9% endometriosis). Other commonly used medications in both groups were mucus medications and ovulation medications, and specifically in PCOS patients, metformin. In PCOS patients, progesterone use significantly affected the length of the follicular phase (18.6 days with progesterone vs. 20.8 days without). Additionally, progesterone influenced the length of the luteal phase (13.6 days with progesterone vs 12.6 days without) and cycle length (34.9 with progesterone vs 37.1 without), however not significantly. In patients with endometriosis, ovulation medications significantly affected the length of the follicular phase (15.8 days with medication vs 16.9 days without).
Conclusion: Medications used in NPT influence some cycle characteristics. The most consistent effect from any medication was seen for progesterone, but only a few effects were significant. There is current, ongoing analyses of naltrexone and surgery effects on cycle biomarkers. Future studies are needed to validate results and may potentially influence NPT therapies prescribed.
Key Words: infertility, NaProTechnology, endometriosis, PCOS
Responses
Great job! Would avoid using unofficial abbreviations such as “meds”. Also, in the discussion section, can you elaborate on bullet point 2 and 3 and include what the result was that was unexpected or expected. That would help point out what your results showed if someone didn’t have time to look closely at your results charts.
Hi Kali, thanks for the feedback. With bullet point 2, we would expect progesterone to shorten the follicular phase and lengthen the luteal phase, which is seen in figure 2. For bullet point 3, it was unexpected that metformin would have a lower mucus score than a higher mucus score since metformin is expected to help normalize the fertility cycle in women with PCOS.
Great job, Karen. Your poster was visually appealing and well-organized. Based on what you learned during your project what interventions would you recommend to someone close to you who was having difficulty with conception?
My recommendations for someone conceiving would vary, depending on what a few of their fertility cycle charts look like (ovulation medications if they are missing peak days, mucus enhancers depending on the quality of their cervical mucus, progesterone depending on the cycle length), sometimes even diet/exercise can help someone, each situation is unique but luckily there are a few options!
Interesting study. Thanks.
Karen – this is so wonderful to see finally come to fruition! I’ve heard about it so much over the past few years. I’m excited to see the next step in this path
the other karen 🙂
Very nice job! Looking forward to getting the paper submitted!
Karen, this seems to be coming together nicely. I’m curious about all the different medications. In theory are those prescribed to affect cycle, mucus, and other factors influencing pregnancy success? If so, is it surprising that there seems to be so few changes with the medications?
Hi Dr. Keefe – yes, it is surprising that there were not as many significant changes, however many changes were trending in the expected direction. Also, having more cycle information would have helped solidify the results (many cycles were dropped if a woman did not completely fill out the chart/missed a few days of charting). More surprising were trends in the opposite direction (such has a lower mucus score in cycles with metformin).
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