RMN Infertility Trials
Since 2009, the RMN has conducted several studies that address various aspects in reproductive medicine - namely female infertility in women with polycystic ovary syndrome (PCOS), in vitro fertilization (IVF), multiple gestations as a result of ovarian stimulation, and optimal treatment for women with a Persisting Pregnancy of Unknown Location (PPUL).
Science Highlight! The RMN PPCOS II study was selected as the lead article in the NIH Director's "Research Matters." In this study published in NEJM, 750 infertile women diagnosed with PCOS were enrolled, and we found that letrozole is better than the current standard therapy in increasing live births for women with polycystic ovary syndrome, which is a leading cause of female infertility. All infants were delivered by February 2013, and the database was locked in May 2013. For more information on the study please go to https://www.clinicaltrials.gov/ct2/show/NCT00719186.
Actively Recruiting:
FIT-PLESE Female trial: Improving Reproductive Fitness through Pretreatment with Lifestyle Modification in Obese Women with Unexplained Infertility - launched July 2015
We will recruit 380 obese women with unexplained infertility, age 18-40 years old with normal ovulatory function and normal ovarian reserve; the couple will have no other major infertility factor. Women will be randomized to one of two arms: increased physical activity and weight loss (intensive) compared to increased physical activity alone with weight maintenance (standard). This 16 week period of lifestyle modification will be followed by three cycles of ovarian stimulation with oral medication (clomiphene), triggering of ovulation with human chorionic gonadotropin (hCG) and intrauterine insemination (IUI). For more information on this trial please go to: https://clinicaltrials.gov/ct2/show/NCT02432209
MOXI trial: Males, Antioxidants and Infertility Trial - launched December 2015
We will recruit 790 heterosexual couples who have been attempting to conceive for ≥12 months into a randomized, placebo-controlled trial of antioxidant formulation for the male partner. Treatment or placebo will run for 3 months during which time, couples will attempt to conceive naturally. For months 4 through 6, women who have not conceived will be treated with clomiphene citrate and intrauterine insemination. For more information, please go to: https://clinicaltrials.gov/ct2/show/NCT02421887
ACTorNOT trial launched in May 2014. We will recruit 276 hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all 3) Expectant management. For more information on the study please go to https://clinicaltrials.gov/ct2/show/NCT02152696
The RMN launched the Psychosocial Outcomes of Multiple Gestations (PsyFi) study in September 2014. This study aims to determine the long term psychosocial and family issues experienced among families that gave birth to children through the use of Assisted Reproductive Technology. PsyFi is a multicenter, retrospective, and observational study that will recruit 360 families equally divided into the three family groups of singletons, twins and higher order multiples (triplets and up).
PhOx trial recruitment completed as of April 2013, and database locked in August 2014. For 840 couples who undergo In Vitro Fertilization (IVF) procedures, the RMN Physiologic Oxygen (PhOx) study is aimed at determining a more effectual oxygen level in the culture conditions which will improve live birth rates. For more information on the study please go to https://www.clinicaltrials.gov/ct2/show/study/NCT01010386.
AMIGOS trial recruitment completed as of September 2012 and database locked in March 2014. For 900 couples with unexplained infertility in whom the female partner ovulates regularly, the RMN Multiple Intrauterine Gestations (AMIGOS) trial tries to identify an ovarian stimulation agent that will help couples successfully obtain their goal of delivering a healthy child with low rates of multiple gestational pregnancies. For more information on the study please go to https://www.clinicaltrials.gov/ct2/show/study/NCT01044862. (The AMIGOS study is sponsored by a grant from the American Recovery and Reinvestment Act (ARRA) of 2009.)