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 5 th 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

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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 PeakBeginningEnd

19. Hormonal Fertility Monitors ClearBlue EasyPersona

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 Day Relative to OvulationProbability of Pregnancy -5.08 -4.17 -3.08 -2.36.34 0.36

23. Markers of Fertile Window Beginning 1.Change in vaginal secretion 2.Estrogen rise in urine 3.Calendar double check calculation End 1.Change in vaginal secretion 2.Basal body temperature rise 3.LH surge

24. Variability of fertile window Fertile Window

25. NFP Methods Mucus Based 1.Billings 2.Creighton 3.2 day Sympto-thermal – Couple to Couple, NW Sympto-hormonal - Marquette Calendar – Standard Days Lactation Amenorrhea

26. Efficacy Definitions The perfect or correct use unintended 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 4 th 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) MMFemale =28.4 (SD = 5.9) CM Female =28.7 (SD = 5.8) MM Male = 30.3 (SD = 6.1) CMMale = 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 cycles of use.  The perfect use pregnancy 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 MonitorMucus N = 197N=161 Pregnancies = 0= 3 3 cycles: 0.000.97 6 cycles: 0.000.97 9 cycles: 0.000.97 12 cycles: 0.000.97 Std Error:.00.016 Typical Use MonitorMucus N = 197N=161 Pregnancies = 10= 21 3 cycles: 0.970.92 6 cycles: 0.950.86 9 cycles: 0.940.83 12 cycles: 0.930.81 Std Error:.022.038

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).

51. Correct Use Pregnancies There were 2 unintended pregnancies per 100 women with correct use during the first 12 months postpartum. The method-related pregnancies occurred in: (i) the amenorrheic period (in the 9th month postpartum), (ii) the 3rd cycle after the return of menses (in the 12th month postpartum).

52. Typical use survival over 12-months Months Women Exposed Cumulative pregnancy rate 11980 31380 61170 12 748

53. Factors in NFP Effectiveness Personalized Instruction Well trained teachers Motivation Communication by couple All methods have similar correct use effectiveness. What you learn depends on what is available in your area (or online).

54. Pregnancy rate over one year by family planning method Correct Use Typical Use  CHANCE8585  SPERMICIDES1829  WITHDRAWAL 427  OVULATION METHOD 3 19(25)*  CONDOMS 215  SDM 512  Marquette Method0.6-2 7 - 12  SYMPTOTHERMAL 0.4-2 8 - 11  PILL0.3 8  IUD0.10.6 *Adapted from: Trussell J. Contraceptive failure in the United States. Contraception. 2004;70:89-96.

55. Typical Use The disconnect: Our critics focus on typical use while we focus on perfect use NFP is inherently different from other methods since it can be used to achieve and is instantaneously reversible. NFP is “Unforgiving” per Trussell. The longer the estimated fertile window, the better the perfect use. Does this longer fertile window and longer abstinence period contribute to higher pregnancy rates? The key concept is motivation and identification of intentions to avoid or achieve at the beginning of each cycle.

56. Pregnancy Rate by Motivation Level High (N = 298)Low (N = 60) Pregnancies = 14Pregnancies = 30 #Rate#Rate 3 months: 299.2.01 7 86.9.05 6 months: 298.0.01 478.0.06 9 months: 496.0.02 6 62.4.07 12 months: 691.6.0213 25.0.08 Rate:8/10075/100

57. Bias in the Literature Trussell: “Contraceptive Failure in the U.S”. 2011 Typical use of fertility awareness based methods 24% Designated as less effective than condoms and withdrawal Results derived from National Survey of Family Growth Self-reported, random sample 7,000 (approx. 50 FABM users) Perfect use data correctly identified for different FABM, but typical use lumped all together His work is considered “authoritative”

58. Challenges in the Adoption of NFP Reality: Only 0.1% of all women in U.S. use NFP and only 0.2% of Catholic women Few physicians understand NFP, fewer would recommend and some are even hostile Why? 1.Ignorance of modern methods of NFP 2.Perception that it is not effective 3.Difficulty with Abstinence 4.Find methods cumbersome to learn and practice 5.Counter cultural to contraceptive mentality /sexual revolution

59. Strategies Education and Evangelization Users 1.Grassroots 2.Fertility Awareness for Young Women 3.Faith Formation Students 1.Incorporate into women’s health curriculum 2.Lectures/presentations Physicians 1.Physician to physician 2.Better science

60. Strategies Collaboration Representatives of all methods should work together to advance NFP FACTS Fertility Awareness Collaborative to Teach the Systems Recognize that not every method is perfect for every user

61. Strategies Improve the Methods Quicker and easier to learn Less confusion Easy Access/Internet/Smart Phones Less Abstinence

62. Bibliography M. Arevalo et al “Efficacy of a new method of family planning: the Standard Days Method,” Contraception 65 (2002) 333-338. M. Arevalo et al ”Efficacy of the new TwoDay Method of family planning,” Fertility and Sterility 82 (2004) 885-892. R. Fehring, “Efficacy and efficiency in natural family planning services,” Linacre Quarterly 76(1) (2009) 9-24. R. Fehring, “Perfect, typical, and imperfect use of natural family planning methods, the problems of a biased approach to research and the realistic needs for improved studies,” Linacre Quarterly 78 (2011) 467-473.

63. Bibliography R. Fehring et al, “Protocol for determining fertility while breastfeeding and not in cycles,” Fertility and Sterility 84 (2005) 805-7. R. Fehring et al, “Randomized comparison of two Internet- supported fertility-awareness-based methods of family planning,” Contraception 88 (2013) 24-30. G. Freundl, “European multicenter study of natural family planning (1989-1995): efficacy and drop-out,” Advances in Contraception 15 (1999) 69-83. B. Gross, “Is the lactational amenorrhea method a part of natural family planning? Biology and policy,” American Journal of Obstetrics and Gynecology 165 (1991) 2014-9.

64. Bibliography M. Howard and J. Stanford, “Pregnancy probabilities during use of the Creighton Model Fertility Care System,” Archives of Family Medicine 8 (1999) 391-402. Indian Council of Medical Research Task Force on Natural Family Planning “Field trial of Billings ovulation method of natural family planning,” Contraception 53 (1996) 69-74. M. Manhart, et al “Fertility awareness-based methods of family planning: A review of effectiveness for avoiding pregnancy using SORT,” Osteopathic Family Physician 5 (2013) 2-8. J. Trussell, “Contraceptive failure in the United States,” Contraception 83 (2011) 397-404. A. Wilcox et al, “Timing of sexual intercourse in relation to ovulation, Effects on the probability of conception, survival of the pregnancy, and sex of the baby,” The New England Journal of Medicine 333 (1995) 1517-21.

65. Thank you/Gracias!