Igniting future research in NaProTechnology

Transcription

1 Igniting future research in NaProTechnology Joseph B. Stanford, MD, MSPH, CFCMC Professor Director, Office of Cooperative Reproductive Health Department of Family and Preventive Medicine University of Utah 2014 July 12

2 Faculty Disclosure I have no financial interest/arrangement that would be considered a conflict of interest.

3 Objectives l To review the scientific context for past, present, and future research in NaProTechnology. l To present recent results from the Creighton Model Effectiveness, Intentions, Behaviors Assessment (CEIBA) study and the international NaProtechnology Evaluation and Surveillance of Treatment (inest) study. l To discuss possible future research directions in NaProTechnology.

4 l Current evidence l Ongoing studies CEIBA NaPro infertility studies inest l Basic or clinical science? l How inclusive? l Future l Top 11

5 Natural Procreative Technology (NaProTechnology) l Medical protocols applied to Creighton Model FertilityCare charting or women in pregnancy Various levels of evidence Rapidly evolving! l Surgical protocols to restore reproductive integrity and function

6 Creighton Model FertilityCare (CrM) l The CrM is taught as an integrated system of true family planning and gynecologic health. To conceive To avoid To understand and manage gynecologic health l There is no attempt to prescribe to couples how it should be used. l Women and couples make their own choices about how to use the method.

7 Current evidence

8 What is the volume of evidence? PubMed (NLM, USA) l Natural family planning 450 ~1/month since 1975 l Natural procreative technology 3 l Cooperative reproductive 9 (all basic science) l RRM 7 (all not related) l Contraception 21,897 ~36/month since 1963 l Hormonal oral contraception 4523 ~13/month since 1986 l In vitro fertilization 27,688 ~66 month since 1979

9 Ongoing studies

10 Creighton Model Effectiveness, Intentions, Behaviors Assessment (CEIBA)

11 CEIBA Aims l To evaluate pregnancies by Creighton Model FertilityCare (CrM) classifications. l To evaluate pregnancy rates according to time periods of specific types of use. l To evaluate pregnancy rates by prospectively stated intentions. l To examine the relationships between childbearing motivations, intentions, and behaviors.

12 University of Utah, Coordina2ng Center Fer2lity Care Centers involved in Project

13 Participants l 306 couples enrolled Women s age: mean 27.8 years l Range years; standard deviation 4.4 years 53% married; 39% engaged; 8% other 29% women with previous birth 83% women white 83% women Catholic 95% women with at least some college education

14 Progress l Follow-up completed in December 2012 l Unexpected challenges Missing data Differences in pregnancy evaluations

15 Incomplete data l Missing CrM charts l Missing pregnancy evaluations l Skipped key questions on pregnancy evaluation l Follow-up forms without instructions documented l Skipped items on follow-up forms

16 Response l Hounded people for missing data FertilityCare Practitioners Participants l Pregnancy reviews Diane Daly and Kathy Rivet

17 CrM pregnancy classifications so far! l 121 pregnancies 70 Achieving-related 3 Method-related 2 Using-related 2 Teaching-related 1 Using- and teaching-related 4 Not CrM-related 8 Unresolved 31 classification not yet finalized Special thanks to Diane Daly, CFCE, and Kathy Rivet, CFCE

18 Intention agreement- by cycle Men Achieving Achieving Neutral Avoiding Abstaining 77 (3.3%) 13 (0.6%) 31 (1.3%) 1 (0.04%) Women Neutral Avoiding 9 (0.4%) 23 (1.0%) 70 (3.0%) 64 (2.8%) 44 (1.9%) 1705 (73.2%) 3 (0.1%) 43 (1.9%) Abstaining 1 (0.04%) 6 (0.3%) 41 (1.8%) 198 (8.5%)

19 Pregnancy rates by cycle intentions Trying as hard as possible to achieve All cycles Women (n=2,616) Men (n=2,425) Proportion of cycles with conception Women (n=98) Men (n=87) 2.1% <1.0% 23.2% 8.8% Trying to achieve 3.3% 3.7% 18.6% 18.9% Neither trying to avoid or achieve 5.9% 7.1% 9.0% 11.0% Trying to avoid 43.8% 44.4% 3.0% 2.9% Trying as hard as possible to avoid 34.4% 32.8% 2.0% 2.0% Planning to abstain 10.1% 10.4% 1.1% 0%

20 Happiness with (hypothetical) pregnancy by cycle- agreement Men Unhappy Neutral Happy TOTAL Unhappy 108 (5.4%) 54 (2.7%) 108 (5.4%) 270 (13.4%) Women Neutral Happy 63 (3.1%) 97 (4.8%) 80 (4.0%) 130 (6.5%) 224 (11.1%) 1148 (57.1%) 367 (18.2) 1375 (68.3%) TOTAL 268 (13.3%) 264 (13.1%) 1480 (73.6%) 2012 (100%)

21 Pregnancy Intention, 1-6 (1=trying hard to achieve; 6=abstaining) Intention for pregnancy over time Female Male P<0.001 for both male and female change in intention over time P=0.16 for male and female difference in intention Cycle

22 Retrospective cohort studies of NaProTechnology for infertility or miscarriage

23 Retrospective cohort studies of NaProTechnology for infertility Lead clinician(s) Location Year published Hilgers Omaha, Nebraska 2004 Boyle Galway, Ireland 2008 Tham Toronto, Canada 2012 Pingitore Carpentier, Rollo Horodenchuk Barczentiwicz Boyle (post IVF) Switzerland New England Ukraine Lublin, Poland Galway and Dublin, Ireland

24 Barczentewicz, conception leading to live birth by time previously trying to conceive N=844 couples

25 Barczentewicz, conception leading to live birth by parity N=844 couples

26 Boyle et al., conception leading to live birth by parity N=397 couples, all having previously failed IVF!

27 International NaProTechnology Evaluation and Surveillance of Treatment (inest) a prospective cohort study

28 inest design l Prospective cohort of couples l NPT practice-based initiation l Follow all couples for 3 years regardless of treatment continuation or discontinuation l Obtain treatment data from NPT physician l Main outcome = live birth

29 inest: current results

30 Enrollment characteristics Clinic location* # enrolled mean age mean yrs trying prior preg. prior IVF Clinton, NJ, USA % 9% Salt Lake City, UT, USA % 2% Gardner, MA, USA % 4% Leamington Spa, UK % 14% Etobicoke, Ontario, Canada % 7% Baton Rouge, LA, USA % 0% Charlottesville, VA, USA % 0% TOTAL % 8% Missing from total na 1% 31% 36% 32% *Clinics in the following sites have each contributed <10 patients to date: St. Louis, MO, USA, Winston Salem, NC, USA, New Brunswick, NJ, USA, Lublin, Poland

31 Events in study Clinic location* Repro surgery # clinic visits Preg Birth Clinton, NJ, USA 8.4% % 37% Salt Lake City, UT, USA 9.4% % 39% Gardner, MA, USA 13.3% % 24% Leamington Spa, UK NR NR 19% 19% Etobicoke, Ontario, Canada 13.5% % 39% Baton Rouge, LA, USA 0% NR 35% 35% Charlottesville, VA, USA 7.1% 5.6 7% 7% TOTAL 8.7% % 30% Missing from total 81% 34% 40% 40% *Clinics in the following sites have each contributed <10 patients to date: St. Louis, MO, USA, Winston Salem, NC, USA, New Brunswick, NJ, USA, Lublin, Poland

32 Conception leading to live birth by time previously trying to conceive

33 Conception leading to live birth by prior live birth

34 Conception leading to live birth by prior IVF

35 Basic or clinical science?

36 Cells Diseases People Practices Research Pipeline Guidelines Development Dissemination Research Basic Research Human Research Practice- Based Research T T T=QI Practice Meta-analyses; Systematic Reviews Implementation Research Adapted from James Mold, MD!

37 Types of science needed to move forward l Bench science l Animal investigation l Clinical observation l Randomized clinical trials l Implementation science l Social science l Economics

38 Types of science needed to move forward l Bench science l Animal investigation l Clinical observation l Randomized clinical trials l Implementation science l Social science l Economics Translational Science

39 NaProTechnology l Based on systematically observing outcomes from thoughtful innovation in clinical applications of prior and current clinical and basic science. l Translational science!

40 Current and future contributions of the Creighton Model & NaProTechnology l Understand normal reproduction l Detect abnormal function early l Understand root causes l Restore normal function l Increase respect for human life l Empower women l Reveal the big picture

41 Basic or clinical science? Both, and the full spectrum of translational science!

42 How inclusive?

43 How inclusive? l NaProTechnology l Creighton Model l Natural Family Planning l Restorative Reproductive Medicine l Cooperative Reproductive Health

44 "Stand with anybody that stands right, stand with him while he is right, and talk with him when he goes wrong. Abraham Lincoln

45 Future

46 Building for the future l Education l Mentoring l Research

47 Education l CME courses for FertilityCare Practitioners and health professionals Pope Paul VI Institute Education Programs AAFCP annual meetings IIRRM meetings and webinars

48 Mentoring

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52 Other challenges l Funding l Publication l Integration Clinicians, teachers, researchers

53 Top 11

54 Building learning communities In the current biomedical research system, it takes an average of 17 years for 14% of new discoveries to be incorporated into practice. The research engine of the future must combine an enthusiasm for discovery with a desire to make the world a better place. Researchers are consultants in this process in which everyone must have a stake. James Mold, MD

55 My top 11 research questions 1. What are the relationships between fertility motivations, intentions, behaviors, and pregnancies during CrM use? (CEIBA) 2. How does use of the communication between spouses about fertility change over time in CrM users? (CEIBA) 3. What is the impact of earlier (NaProcompetent) surgical evaluation and treatment in NaProTechnology for infertility? (inest)

56 My top 11 research questions 4. What is the sensitivity and specificity of expert review of the CrM chart (and specific parameters of the chart) for predicting subfertility? (CEIBA and inest) 5. How can we model effectiveness of NaProTechnology (based on known factors such as age, prior time trying) for infertility to give couples the most accurate possible prognosis for achieving a live birth? (IIRRM)

57 My top 11 research questions 6. What is the role of diet intervention in the treatment of NaProTechnology for infertility? (inest) 7. How can we most expediently reduce or eliminate abnormal bleeding and optimize endometrial function for fertility? (inest)

58 My top 11 research questions 8. How can we best assess outcomes and improve NaProTechnology treatment protocols for a. Postpartum depression b. Premenstrual syndrome c. Preterm birth prevention

59 My top 11 research questions 9. What is the role of the microbiome in subfertility and abnormal reproduction? 10. How can the new sciences of genomics and proteomics be applied to better understand and treat reproductive disorders in a NaProTechnology context? 11. What is the impact of (sub)optimal cycle conditions at conception on subsequent, growth, development, and health? (HOPE)

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61 Office of Cooperative Reproductive Health