FIT-PLESE Randomization Dataset in Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

Randomization Data
Study Description
A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification program that tracked increased physical activity and weight loss (intensive) compared with a recommendation to track of increased physical activity alone with weight maintenance (standard) in women with obesity and unexplained infertility. This 16-week period of lifestyle modification was 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). The goal for both treatment groups was to maintain levels of physical activity and weight achieved during the pretreatment phase during the empiric infertility treatment phase. The primary outcome of this study was a good birth outcome which was defined as singleton or twin infant(s) born at ≥ 37 weeks between 2500 and 4000g without a major congenital anomaly. Obese women with unexplained infertility, ages 18-40 years old. Subjects had normal ovulatory function and normal ovarian reserve. Couples had no other major infertility factors.