A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.
详细描述
According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 20 and 40 years old;
- •Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
- •Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
- •The total number of transfer cycles was < 3;
- •Volunteer to participate in the study and sign the informed consent.
排除标准
- •Patients with chromosomal abnormalities;
- •Contraindications to hormone replacement therapy;
- •Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- •Participating in other clinical studies.
结局指标
主要结局
Clinical pregnancy rate
时间窗: 45 days after embryo transfer
Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.
次要结局
- Early pregnancy loss rate(12 weeks after embryo transfer)
- Embryo implantation rate(45 days after embryo transfer)
- Incidence of thrombosis(12 weeks after embryo transfer)
- Incidence rate of gestational hypertension(45 weeks after embryo transfer)
- Premature birth rate(41 weeks after embryo transfer)
- Proportion of low birth weight infants(41 weeks after embryo transfer)
研究者
Li-jun Ding
principal investigator
Nanjing University