FIT-PLESE Phase II End of Study Dataset in Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

Phase II End of Study 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.

II期研究终末数据
研究概况
本研究为一项双臂、多中心、前瞻性随机临床试验，纳入肥胖伴不明原因不孕症女性，对比强化生活方式干预方案（通过监测增加体力活动并实现减重）与标准干预方案（仅建议增加体力活动并维持体重）的干预效果。该16周生活方式干预阶段结束后，受试者将接受开放标签的经验性不孕症治疗方案，具体包括3个周期的口服药物卵巢刺激（枸橼酸氯米芬（clomiphene citrate, CC））、人绒毛膜促性腺激素（human chorionic gonadotropin, hCG）触发排卵，以及宫腔内人工授精（intrauterine insemination, IUI）。两组受试者的目标均为在经验性不孕症治疗阶段，维持其在预处理阶段达到的体力活动水平与体重。本研究的主要结局为良好妊娠结局，定义为单胎或双胎婴儿于孕37周及以上分娩，出生体重介于2500g至4000g之间，且无重大先天性畸形。研究对象为年龄18~40岁的肥胖伴不明原因不孕症女性，需具备正常排卵功能与正常卵巢储备，且夫妇双方无其他明确的主要不孕症诱因。