The Penn RMU has been part of the RMN since the Network's inception over twenty two years ago and has played a leadership role in the design, implementation, analysis and publication of many of the RMN's studies. Specifically, of the six major studies the RMN has completed to date, three have been the proposed Penn concept protocols, one resulting in two NEJM publications and the second resulting in three Fertility and Sterility publications comprising the centerpiece of a Controversies section of the journal. The third, the first IVF clinical trial performed by the RMN, evaluating the effect of physiologic (5%) oxygen tension on delivery rates, has randomized to date over 750 couples and is projected to close recruitment by the end of the current funding period. It is anticipated that this trial will establish the standard of care for human embryo culture. The present Penn concept protocol proposes to address possibly the most burning problem in the clinical practice of IVF: multiple pregnancy. It is hypothesized that a single blastocyst transfer results in a delivery rate similar o double blastocyst transfer in good prognosis patients. This will be addressed by performing a randomized clinical trial of a single vs. double blastocyst transfer. In addition, we propose to include subsequent frozen/thawed embryo transfer cycles in order to determine cumulative delivery rates. Thus, the proposed design will not only determine the delivery rate of single blastocyst transfer, but will also help establish the optimal transfer algorithm for maximizing delivery rates and minimizing multiple pregnancy rates in good prognosis patients undergoing IVF. As designed, the study does not utilize federal funds for any aspects of the human IVF laboratory work and, as such, is compliant with current federal restrictions. We strongly believe, that upon completion of the proposed study, the impact on current practice will be extremely significant. Given the track record, excellence of the clinical research infrastructure and the proven expertise in the design, recruitment and analysis of multicenter clinical trials, the members of the Penn RMU are looking forward to continue their participation in the Reproductive Medicine Network. It should be mentioned that in the present application, we propose to continue our collaboration with the University of Connecticut Infertility program, which is the largest program in Connecticut and includes a CREST program graduate. Dr. Laurence Engmann. This collaboration, which covers a distinct and separate geographic area, has proven invaluable to the execution of the current RMN IVF clinical trial (PhOx) with the recruitment of the highest number of subjects for the trial.

Public Health Relevance

Multiple pregnancies are the major complication of in vitro fertilization treatment affecting both mother and her newborns. Decreasing the incidence of multiple births is of high public health importance. The proposed clinical trial aims at markedly decreasing this undesired outcome taking advantage of recent advances that have resulted in embryos of high implantation potential.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD027049-22
Application #
8740515
Study Section
Special Emphasis Panel (ZHD1-DSR-L (55))
Program Officer
De Paolo, Louis V
Project Start
1990-04-01
Project End
2018-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
22
Fiscal Year
2014
Total Cost
$307,921
Indirect Cost
$115,471
Name
University of Pennsylvania
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Diamond, Michael P; Legro, Richard S; Coutifaris, Christos et al. (2017) Sexual function in infertile women with polycystic ovary syndrome and unexplained infertility. Am J Obstet Gynecol 217:191.e1-191.e19
Styer, Aaron K; Jin, Susan; Liu, Dan et al. (2017) Association of uterine fibroids and pregnancy outcomes after ovarian stimulation-intrauterine insemination for unexplained infertility. Fertil Steril 107:756-762.e3
Engmann, Lawrence; Jin, Susan; Sun, Fangbai et al. (2017) Racial and ethnic differences in the polycystic ovary syndrome metabolic phenotype. Am J Obstet Gynecol 216:493.e1-493.e13
Mumford, Sunni L; Legro, Richard S; Diamond, Michael P et al. (2016) Baseline AMH Level Associated With Ovulation Following Ovulation Induction in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab 101:3288-96
Pal, Lubna; Zhang, Heping; Williams, Joanne et al. (2016) Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Clin Endocrinol Metab 101:3027-35
Dokras, Anuja; Sarwer, David B; Allison, Kelly C et al. (2016) Weight Loss and Lowering Androgens Predict Improvements in Health-Related Quality of Life in Women With PCOS. J Clin Endocrinol Metab 101:2966-74
Hansen, Karl R; He, Amy Linnea W; Styer, Aaron K et al. (2016) Predictors of pregnancy and live-birth in couples with unexplained infertility after ovarian stimulation-intrauterine insemination. Fertil Steril 105:1575-1583.e2
Hayes, M Geoffrey; Urbanek, Margrit; Ehrmann, David A et al. (2016) Corrigendum: Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations. Nat Commun 7:10762
Legro, Richard S; Dodson, William C; Kunselman, Allen R et al. (2016) Benefit of Delayed Fertility Therapy With Preconception Weight Loss Over Immediate Therapy in Obese Women With PCOS. J Clin Endocrinol Metab 101:2658-66
Usadi, Rebecca S; Diamond, Michael P; Legro, Richard S et al. (2015) Recruitment strategies in two reproductive medicine network infertility trials. Contemp Clin Trials 45:196-200

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