Non-pharmacological, Holistic and Alternative Therapy and Fertility in Women’s Health

1. Non-pharmacological, Holistic and Alternative Therapy and Fertility in Women’s Health Julie A. Mickelson, MD April 5, 2014

2. Acknowledgement Dr. Richard Fehring, Director Marquette Institute of NFP

3. Compadres

4. Objectives • 1. Discuss how Natural Family Planning (NFP) works and its historical development. • 2. Describe the different methods of NFP and evidence of their effectiveness. • 3. Discuss challenges in the adoption and acceptance of NFP and directions for the future.

5. How Does NFP Work? • Men are always fertile. • Women are only fertile for a short time. • If you don’t want to get pregnant, don’t have sex on the fertile days. • If you want to get pregnant have sex on the fertile days.

6. How Does NFP Work? • Monitor and interpret natural biological markers of fertility. • Define the fertile and infertile times of the cycle. • Use the information to avoid or achieve pregnancy.

7. Advantages of NFP • Non-pharmalogical : Safe, no side effects • Holistic: Fertility is a gift, not a disease. Shared method between the couple Fits with moral, ethical, and spiritual beliefs Can be used to avoid or achieve • Therapeutic Menstrual cycle the 5th vital sign Identify and treat fertility problems

8. History of NFP 1920’s • Ogino in Japan 1923 • Determined ovulation preceded menstruation by 14 days • Speculated life span of ovum 12-24 hours • Life span of sperm 3-5 days • Developed original calendar method of NFP

9. History of NFP 1930’s • Knaus – Austria, Latz –U.S. (Chicago) • “Rhythm” term coined by Latz • Shortest cycle minus 19 days, start of fertile window next day. • Subtract shortest from longest and add 8 days determines length of fertile window. • Ex. 26d shortest, 30d longest : Fertile Window day 8-19.

10. History of NFP 1950’s and 1960’s • “Modern” Methods of NFP developed • Roetzer and Keefe identified the basal body temperature shift began to develop Sympto-thermal methods. • Billings method developed based on cervical mucus sign. • Next two decades marked refinement and dissemination of these methods.

11. History of NFP 1990’s • NaPro Technology Developed by Dr. Hilgers at the Pope Paul the VI Institute in Omaha based on Creighton Model of NFP • Low Tech Standard Days (Cycle Beads) and 2 day mucus method developed at Georgetown

12. Chiapas

13. History of NFP “New Millenium” • High Tech Marquette Model developed by Dr. Fehring at Marquette University. Utilizes Clear Blue Fertility Monitor to measure hormones directly

14. Biological Markers • Menstrual Cycle • Cervical Mucus • Basal Body Temperature • Urinary Hormones

15. 29

16. Key Observations • Estrogen causes cervical mucus production • LH triggers ovulation and peak type mucus • The corpus luteum produces progesterone which dries up the mucus and causes the temperature rise

17. An Introduction to NFP: Diocesan Development Program for NFP Fehring, R.,Kitchen, S., & Schivanandan, M (Ed. Notare T.) 2010.

18. Mucus Cycle Beginning Peak End

19. Hormonal Fertility Monitors ClearBlue Easy Persona

20. Clearblue Fertility Monitor • Low Fertility • High Fertility • Peak Fertility

21. The 6 day Window of Fertility • Sperm live in cervical mucus for up to 5 days • Egg lives 12-24 hours • Confirmed by Wilcox et al NEJM -1995 1. 221 healthy women planning to get pregnant 2. Measured urine hormones to estimate day of ovulation 3. Calculated probability of pregnancy of each day relative to ovulation day. 4. Intercourse on only one day

22. The 6 day Window of Fertility

23. Markers of Fertile Window • Beginning • Change in vaginal secretion • Estrogen rise in urine • Calendar double check calculation • End • Change in vaginal secretion • Basal body temperature rise • LH surge

24. Variability of fertile window Fertile Window Fertile Window Fertile Window

25. NFP Methods • Mucus Based • Billings • Creighton • 2 day • Sympto-thermal – Couple to Couple, NW • Sympto-hormonal - Marquette • Calendar – Standard Days • Lactation Amenorrhea

26. Efficacy Definitions • The perfect or correct useunintended pregnancy rate refers to those pregnancies that occur when the method is used consistently and according to instructions. • The typical use pregnancy rate includes the combination of unintended pregnancies when the methods are followed correctly and the unintended pregnancies that occur when users of the method do not always follow the instructions of the method correctly. • Difference between correct use and incorrect use gives indication of how hard it is to use the method.

27. Billings Method • Fertile period begins with onset of mucus or sensation of vulvar dampness. • Peak day last day of egg while mucus or lubricative sensation. • Avoid intercourse during menses. • Have intercourse only on alternate dry days prior to onset of fertile phase. • Avoid intercourse during fertile days and until evening of the 4th day past peak day.

28. Billings Method Efficacy • Indian Study, published in Contraception, 1996 • 2,059 Women from 5 states in India • 21 month study • Correct Use 1% • Typical Use 10.5% at 12 months, 15.9% at 21 months

29. Creighton Model • Standardized version of the Billings ovulation method. • Rigorous teacher training. • Uniform recording system for vaginal discharges.

30. Creighton Model Efficacy • Howard and Stanford, Archives of Family Medicine, 1999 • Observational Cohort 701 clients • 18 months follow up • Correct Use 3%, Typical Use 17% • Most typical use pregnancies resulted from deciding to achieve pregnancy or having intercourse on a fertile day

31. NaPro Technology • Cooperative and restorative reproductive medicine. • Charting is core of evaluation. • Optimizing ovulation, mucus flow, progesterone levels. • Surgical correction of endometriosis • Alternative approach to In Vitro Fertilization

32. 2 Day Method • Georgetown University • Algorithm developed for women without regular cycles. • Analyzed cycles and probability of pregnancy. • Did I see mucus today? Yesterday? • If either answer is yes consider it a fertile day. • If both no than it is an unfertile day. • Especially helpful in low literacy • Correct Use 3.5%, Typical Use 13.7%

33. Teacher Training

34. Vikings Fans are Everywhere

35. Sympto-thermal Method • Start of fertile window identified by mucus sign. • End of fertile window defined by temperature rise • Double check adds calendar calculation to start of fertile window and fertile window may start before first day of mucus sign

36. Sympto-thermal Efficacy • European Multicenter Study • Published in Contraception in 1999 • Participants indicated pregnancy intention for the next cycle • Single check (mucus/temp) 214 women, typical use 8.5% • Double check (calendar/mucus/temp) 1046 women, typical use 2.6%

37. Sympto-Hormonal Method • Developed at Marquette University, Marquette Model • Clear Blue Fertility Monitor used to define fertile window with double check of the mucus sign. • Urinary hormone testing is more precise in estimating ovulation than mucus or temperature.

38. Charting CM & HM

39. Cohort Comparison: MM (N=307) vs. CM (N=312) • MM Female = 28.4 (SD = 5.9) • CM Female = 28.7 (SD = 5.8) • MM Male = 30.3 (SD = 6.1) • CM Male = 30.7 (SD = 6.0) • Correct Use: MM = 98.0 vs CM = 97.4 • Typical Use: MM = 87.5 vs CM = 77.2 • Fisher Test: Greater portion of CM unintended pregnancy = 3.57; p < 0.05 (28 vs 41)

40. Length of Fertility (N=1149) • HM was 6.1 days (SD = 2.6) • Mucus was 11.1 days (SD = 5.8) • (t = 28.33, p < 0.000) • (r = 0.18, p < 0.000) 11.1 6.1

41. Randomized Comparison of Two Internet Supported Natural Family Planning Methods (Final Efficacy Results) HHS Grant Funded Study

42. Specific Aims • To compare the efficacy in the use of two internet-supported methods of NFP (i.e., EHFM and CMM) in aiding couples to avoid pregnancy. • To compare the satisfaction and ease of use in the use of two internet-supported methods of NFP (i.e., EHFM and CMM). • To compare the mutual motivation in the use of two internet-supported methods of NFP (i.e., EHFM and CMM).

43. Perfect Use Efficacy • The perfect use and total unintended pregnancy rates of the two study groups are based upon 1,126 cycles of correct use and 2,780 total cyclesof use. • The perfect usepregnancy rate per 100 women over 12 months of use in the EHFM group was 0 for the monitor group and 2.7 for the mucus group. • There were no differences between the two groups in perfect use pregnancy rates.

44. Net Unintended Pregnancy Rates Correct Use Monitor Mucus Typical Use Monitor Mucus N = 197 N=161 Pregnancies = 10 = 21 3 cycles: 0.97 0.92 6 cycles: 0.95 0.86 9 cycles: 0.94 0.83 12 cycles: 0.93 0.81 Std Error: .022 .038 N = 197 N=161 Pregnancies = 0 = 3 3 cycles: 0.00 0.97 6 cycles: 0.00 0.97 9 cycles: 0.00 0.97 12 cycles: 0.00 0.97 Std Error: .00 .016

45. Standard Days • CycleBeads plastic necklace • Women often incorrectly identify what they believe are days of fertility • Fixed formula used to define fertile phase as day 8-19 for women with cycles between 26-32 days, (12 day overlaps possible variation in actual 6 day window) • Rubber ring to advance each day. Red bead first day of menses. Brown infertile. White fertile. • Simple to teach and learn, especially in low resource setting • Sold at Whole Foods

46. Standard Days Efficacy • Arevalo, Jennings, Sinai Georgetown University • Formula developed using data from 7500 cycles with computer simulation. • Days 8-19 maximal protection, minimal abstinence • 478 women from Peru, Bolivia, and Philippines • Correct Use 4.75%, Typical Use 12%

47. Chiapas

48. Breastfeeding • Difficult to identify fertility during transition to regular cycles • Can’t rely on temperature with little sleep • Mucus may be continuous and confusing to interpret • Ovulation can happen before first menses • High motivation to avoid pregnancy and often frustration

49. Lactation Amenorrhea Method • Fully Breastfeeding • Less than six months after delivery • No vaginal bleeding after 56 days postpartum • 2% chance of pregnancy if these three criteria fufilled. • Helps decrease amount of abstinence required.

50. The Breastfeeding Protocol • Trigger a cycle by pushing the “M” button on the monitor. • Fast forward the monitor to day 5. • The next 20 days the monitor will ask for a test. • Test your first morning urine every other day. • When a “high” is recorded, test the urine every day. • Re-trigger the monitor and fast forward every 20 days. • Continue steps 1-6 until you detect a Peak reading and resume menses. • Intercourse instructions are: • To avoid pregnancy, refrain from intercourse on High and Peak days and three full days after the last Peak day. R. Fehring, M. Schneider, & M.L. Barron, (2005) “Protocol for determining fertility while breast-feeding,” Fertility and Sterility 84: 805-7. (N=10; Fertility monitor + mucus).