A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- euploidy rate
研究概览
简要总结
This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A. Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:
Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
PPOS group: Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.
The primary outcome is the euploidy rate of blastocysts.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of women <43 years at the time of ovarian stimulation for IVF
- •Antral follicle count (AFC) >=5 on day 2-5 of the period
- •PGT-A indicated for advanced maternal age (>=38 years), recurrent miscarriage (>=2 consecutive miscarriage) and repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success), recurrent foetal aneuploidy
排除标准
- •Presence of a functional ovarian cyst with E2>100 pg/mL
- •Recipient of oocyte donation
- •Presence of hydrosalpinx or endometrial polyp which is not surgically treated
研究组 & 干预措施
Antagonist group
Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
干预措施: GnRH antagonist (Drug)
PPOS group
Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.
干预措施: oral Duphaston (Drug)
结局指标
主要结局
euploidy rate
时间窗: 1 month after oocyte retrieval
euploidy rate of blastocysts
次要结局
- birthweight of newborns(1 year after FET)
- clinical pregnancy(6 weeks' gestation)
- progesterone level on the trigger day(2 days before oocyte retrieval)
- biochemical pregnancy(6 weeks' gestation)
- miscarriage(22 weeks of pregnancy)
- number of mature oocytes(1 day after oocyte retrieval)
- implantation rate(6 weeks' gestation)
- ongoing pregnancy(12 weeks' gestation)
- live birth rate(1 year after FET)
- number and grading of blastocysts(1 week after oocyte retrieval)
- positive serum hCG(2 weeks after FET)
- serum baseline FSH(day 2-3 of period)
- multiple pregnancy(multiple pregnancy beyond gestation 12 weeks)
- ectopic pregnancy(ectopic pregnancy during 12 weeks' gestation)
- estradiol level on the trigger day(2 days before oocyte retrieval)