Update on inest. and CrM chart comparison study. Joseph B. Stanford, MD, MSPH, CFCMC Director of Research, IIRRM

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1 Update on inest and CrM chart comparison study Joseph B. Stanford, MD, MSPH, CFCMC Director of Research, IIRRM Professor and Director, Office of Cooperative Reproductive Health Department of Family and Preventive Medicine University of Utah 2015 July 15

2 inest Purpose Methods Enrollment Recent results Future CrM chart review study Purpose Methods Opportunity

3 inest international NaProTechnology Evaluation and Surveillance of Treatment

4 inest purpose Evaluate outcomes ( success rates ) of NaProTechnology treatment for couples seeking treatment to have a live birth. Take advantage of natural variation in practice to assess the impact of the use and timing of different interventions.

5 inest methods Prospective cohort of couples NPT practice-based initiation Multiple centers, multiple countries Follow all couples for 3 years regardless of treatment continuation or discontinuation Obtain treatment data from NPT physician Main outcome = live birth Secondary outcomes = low birthweight, preterm birth

6 inest enrollment Currently 672 couples! Last year 599

7 Enrollment characteristics (2014) Clinic location* # enrolled mean age mean yrs trying prior preg. prior IVF Clinton, NJ, USA % 8.7% Salt Lake City, UT, USA % 2.4% Gardner, MA, USA % 4.4% Leamington Spa, UK % 14.0% Etobicoke, Ontario, Canada % 6.7% Baton Rouge, LA, USA % 0% Charlottesville, VA, USA % 0% TOTAL % 7.7% Missing from total na 1.2% 31.4% 36.4% 31.6% *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

8 Events in study (2014) Clinic location* Repro surgery # clinic visits Preg Birth Clinton, NJ, USA 8.4% % 37.3% Salt Lake City, UT, USA 9.4% % 38.8% Gardner, MA, USA 13.3% % 24.4% Leamington Spa, UK NR NR 19.3% 19.3% Etobicoke, Ontario, Canada 13.5% % 39.4% Baton Rouge, LA, USA 0% NR 35.3% 35.3% Charlottesville, VA, USA 7.1% % 7.1% TOTAL 8.7% % 30.4% Missing from total 80.8% 33.9% 40.2% 39.9% *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

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

10 Conception leading to live birth by prior live birth (2014)

11 Birth weight by treatment at conception (n=189)

12 Gestational age by treatment at conception (n=193)

13 Live births and newborn hospital stay (n=333 and n=195, respectively) Percent (%) Live Birth/Total Pregnancies Newborn Hospital Stay > 7 Days Pregnancy Outcomes

14 Follow-up questionnaire response rates Qnrs sent to women Women s response rate 61% 50% Qnrs sent to men Men s response rate 42% 24% Women, % pregnant 52% 65%

15 Follow-up questionnaire response rates Qnrs sent to women Women s response rate 61% 50% Qnrs sent to men Men s response rate 42% 24% Women, % pregnant 52% 65% 2014: compensated 2015: not compensated

16 inest current and future No funding currently! Actively pursuing additional funding Long-term sustainability?

17 inest proposed revamp Rename and broaden Levels 1, 2, 3, 4

18 Rename and expand Any restorative reproductive medicine approach More comparative data Same or similar acronym? enest = extended natural evaluation of systems of treatment (?!)

19 Level 1 basic outcome data Yearly reporting of core data For each couple starting treatment Age of woman and man Time attempting Prior treatments (yes/no) Prior live birth and pregnancy (yes/no) Surgery (date and basics) Pregnancy dates and outcomes

20 Level 1: basic outcome data Does not require individual consent of couples Annual report (individual clinics not identified) Analogous to SART, HFEA, ESHRE, others Holding our profession (RRM) accountable to ourselves and to the public Web-based or spreadsheet reporting Could be facilitated by RRM-EMR Could be expanded to other RRM outcomes eventually

21 Level 2: prospective enrollment Consent individual couples prospectively Level one data, plus Detailed questionnaire data at enrollment and at follow-up Learn what happened to patients who disappeared! This is the current inest study design Could be facilitated by RRM-EMR

22 Level 3: cycle-based data Enroll couples prospectively Level 1 and 2 data plus Cycle-specific treatments used, charting, and online cycle reviews shared between patient and clinician, with automatic data transfer Could be greatly facilitated by RRM-app

23 Level 4: randomized trials Level 2 or 3 plus Invite suitable patients to enroll in randomized trials, e.g., Early versus delayed surgical intervention Letrozole versus clomiphene without PCOS Dietary intervention (specific or general) etc.

24 How to fund this? Level 1: participating physicians and clinics Level 2: external funding for follow-up questionnaires Level 3: fees from app users? Level 4: requires major external funding

25 Funding to date Atlas Foundation University of Utah internal Primary Children s Medical Foundation, Salt Lake City, UT St. Augustine Foundation Mary Cross Tippmann Foundation Women s Reproductive Health Foundation

26 Creighton Model chart review study (clinical validation)

27 CrM charts reflect underlying fertility status

28 CrM chart comparison purpose Evaluate sensitivity, specificity, positive predictive value, negative predictive value, and proportion of subfertility correctly predicted by expert Creighton Model chart reviewers (medical consultants, practitioners, and educators). Proof of principle

29 Chart study methods Approximately 30 matched pairs inest = subfertile or infertile CEIBA = normally fertile Matched by age, parity First 100 days of charting (without intercourse) Randomly ordered

30 Chart study methods Volunteers review via online questionnaire First answer questions about training and experience with Creighton Model charting and other types of charting Optional anonymous or acknowledged Then review each chart blindly Qualitatively assess specific parameters Classify each as subfertile or normally fertile We estimate total review time = 6 hours

31 Chart study analysis Analyze with 2x2 tables for sensitivity, specificity, etc. We will also look objectively at each parameter statistically Menstrual flow score Mucus cycle score Number of days of brown bleeding Duration of postpeak phase etc.

32 Watch for announcement!

33 Every kind of support makes a difference! Review for the chart study Become a member of IIRRM Give a webinar Work on a committee Present to physicians in your area Sponsor a conference in your area Donate Mentor

35 Office of Cooperative Reproductive Health

Igniting future research in NaProTechnology

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