Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
Status:
Completed
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification
program with tracked increased physical activity and weight loss (intensive) compared to
recommendations to tracking of increased physical activity alone with weight maintenance
(standard) in women with obesity and unexplained infertility. This 16 week period of
lifestyle modification will be followed by an open label empiric infertility treatment
regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene
citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and
intrauterine insemination (IUI).
Phase:
Phase 3
Details
Lead Sponsor:
Yale University
Collaborators:
Augusta University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Penn State University University of California, San Francisco University of North Carolina University of Oklahoma University of Pennsylvania