Effects of GLP-1 Receptor Agonists Combined With Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Obese Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
The goal of this clinical trial is to examine whether GLP1-RA and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a wish to conceive;
- •Women with PCOS (Rotterdam criteria);
- •28 kg/m2≤BMI<35kg/m2;
- •Age: 18-40 years old
排除标准
- •Women with diseases unsuitable for pregnancy or any other contraindications to infertility treatment Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine abnormalities that may affect assisted reproductive outcomes, untreated hydrosalpinx Male azoospermia, severe oligozoospermia and asthenospermia, or patients receiving donor sperm treatment Chromosomal abnormalities, patients planning preimplantation genetic testing (PGT) or donor oocyte treatment History of recurrent miscarriag Allergic to or contraindicated for GLP-1 class medications.
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: First cycle of IVF/ICSI-ET (the first frozen-thawed embryo transfer cycle if all embryos are cryopreserved after oocyte retrieval)
Ongoing Pregnancy Rate (OPR) The percentage of embryo transfer cycles with an intrauterine pregnancy sustained beyond 20 gestational weeks, with a gestational sac and fetal cardiac activity confirmed via transvaginal ultrasound, out of all embryo transfer cycles.
次要结局
未报告次要终点
研究者
Huangshuo
Associate Professor
Peking University Third Hospital