NCT07811895尚未招募不适用
Dual Glucose-dependent Insulinotropic Peptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Receptor Agonist in Women With Obesity for Frozen Embryo Transfer (FET): Pragmatic, Multicenter, Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,510
- 试验地点
- 1
- 主要终点
- Good birth outcome rate
研究概览
简要总结
To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-40 years;
- •Body Mass Index(BMI) ≥ 28kg/m2;
- •Women who intend to undergo frozen-thawed embryo transfer;
- •At least one embryo available for transfer;
- •Be capable of giving informed consent.
排除标准
- •Women who have been diagnosed with diseases affecting uterine cavity or endometrial receptivity;
- •Presence of endocrine disorders that may significantly affect body weight;
- •Use of drugs that may cause significant weight changes within 8 weeks before screening;
- •Presence of contraindications to the use of dual GIP/GLP-1 receptor agonist;
- •Previous bariatric surgery (e.g., gastric bypass) or planning to undergo such surgery during the study period;
- •Serum triglycerides (TG) > 5.64mmol/L;
- •Calcitonin≥50 ng/L;
- •Presence of medical contraindications to assisted reproductive technology and/or pregnancy;
- •Any other condition considered inappropriate for participation by the investigator.
研究组 & 干预措施
Delayed FET
Experimental
Participants will receive 16-week tirzepatide pretreatment prior to FET alongside lifestyle modification guidance, with a target weight loss of 10%-15% of total body weight.
干预措施: Dual GIP/GLP-1 receptor agonist (Drug)
Standard FET
No Intervention
Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.
结局指标
主要结局
Good birth outcome rate
时间窗: at delivery
good birth outcome is defined as live birth(s) at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.
次要结局
- Birth weight(at delivery)
- Biochemical pregnancy rate(12-17 days after frozen embryo transfer)
- Clinical pregnancy rate(28-35 days after frozen embryo transfer)
- Implantation rate(28-35 days after frozen embryo transfer)
- Pregnancy loss rate(From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months)
- Live birth rate(at delivery)
- Gestational weight gain(at delivery)
- Incidences of obstetric and neonatal complications(From the establishment of clinically recognized pregnancy until six weeks after delivery)
- Incidence of composite endpoint of obesity-related pregnancy complications(From the establishment of clinically recognized pregnancy until six weeks after delivery)
- Incidence of congenital anomalies(From the establishment of clinically recognized pregnancy until six weeks after delivery)
研究者
研究点 (1)
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