Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI 18~23 kg/m2
- •Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
- •Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts
排除标准
- •Using embryos from donor oocytes
- •Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
- •Moderate or severe endometriosis
- •Untreated unilateral or bilateral hydrosalpinx
- •Uterine adenomyosis, uterine myoma (submucous,intramural myoma >4 cm),>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus
研究组 & 干预措施
Experimental-HMG stimulation group
Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer
干预措施: human menopausal gonadotrophin (Drug)
Control-HRT group
Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer
干预措施: hormone replacement therapy (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 10th week after embryo transfer
Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET）
次要结局
- Cycle cancellation rate(the day of embryo transfer)
- Implantation rate(4th weeks after embryo transfer)
- Clinical pregnancy rate(4th weeks after embryo transfer)
- Biochemical pregnancy rate(4th weeks after embryo transfer)
- Early miscarriage rate(12th weeks gestational age)