A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Embryo implantation rate
研究概览
简要总结
This is a single-center, prospective, randomized controlled study. Patients with single blastocyst transfer in the freeze-thaw cycle, aged from 20 to 38 years, with less than three transfers, and with HRT-cycle single D6 blastocyst transfer in the current cycle were enrolled as the study participants. They were randomized into two groups using an Excel table, and the efficacy was evaluated in a blinded manner by a third party who was unaware of the grouping; the data summary phase was performed by blinded statistical analysis with triple separation of the investigator, operator, and statistician.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 38 years.
- •Less than three transfers.
- •Undergoing HRT freeze-thaw cycle single blastocyst transfer in the current cycle.
- •Having consented to participate in this study and signed the informed consent form.
排除标准
- •Chromosomal abnormality in either the patient or their partner
- •Contraindications to hormone replacement therapy.
- •Patients with intramural myoma affecting the morphology of the uterine cavity, severe adenomyosis, endometriosis, congenital uterine anomalies, endometrial tuberculosis, intrauterine adhesion and other diseases significantly affecting embryonic implantation.
- •Currently participating in another clinical study.
研究组 & 干预措施
Progesterone + 7
the transfer of day 6 blastocyst on the 7th day of progesterone supplementation
干预措施: progesterone (Drug)
Progesterone + 6
the transfer of day 6 blastocysts on the 6th day of progesterone supplementation
干预措施: progesterone (Drug)
结局指标
主要结局
Embryo implantation rate
时间窗: 30 days after embryo transplantation
次要结局
未报告次要终点
研究者
Li-jun Ding
Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing University