A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Embryo implantation rate
研究概览
简要总结
This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients.
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 vaginal progesterone added group (test group). Group B was the regular FET 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
- 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
- •Aged between 20 and 40 years old;
- •BMI: 18-28 kg/m2；
- •Consistent with the diagnosis of repeated implantation failure of unknown reasons, the previous embryo transfer situation meets one of the following:
- •Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥ 2 high quality cleavage-stage embryos +≥ 1 blastocysts;
- •At least 1 high-quality embryo remained for embryo transfer;
- •Volunteer to participate in the study and sign the informed consent form.
排除标准
- •Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
- •Adverse pregnancy history (stillbirth, fetal malformation, etc.);
- •Severe paternal factors: need for TESA or PESA;
- •Failure of embryo implantation due to any definite reason, including but not limited to: endometrial adhesion (moderate to severe), thin endometrium (<7 mm before transformation), endometritis, endometriosis (medium or severe), adenomyosis, untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids > 4.0 cm and/or endometrial compression), reproductive malformation, serious immune disease, serious coagulation function abnormality;
- •Chromosome abnormality of either spouse;
- •Those with contraindications to pregnancy or assisted reproductive technology.
研究组 & 干预措施
Vaginal progesterone supplementation
90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support
干预措施: progesterone vaginal sustained-release gel (Drug)
结局指标
主要结局
Embryo implantation rate
时间窗: 45 days after embryo transfer
The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
次要结局
- Early pregnancy loss rate(12 weeks after embryo transfer)
- Persistent pregnancy rate(20 weeks after embryo transfer)
- Clinical pregnancy rate(45 days after embryo transfer)
- Live birth rate(40 weeks after embryo transfer)
研究者
Li-jun Ding
principal investigator
Nanjing University