Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s). Randomized, Single-blind, Multicenter Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,154
- 试验地点
- 9
- 主要终点
- Clinically progressive pregnancy rate between groups
研究概览
简要总结
Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
- •Frozen embryos must be at least D3 stage;
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice or state guardianship
结局指标
主要结局
Clinically progressive pregnancy rate between groups
时间窗: 12 weeks of amenorrhea
Measured on first-trimester ultrasound
次要结局
- Occurrence of a biochemical pregnancy between groups(Day 14)
- Occurrence of a clinical pregnancy between groups(6 weeks of amenorrhea)
- Occurrence of pregnancy between groups(Day 14)
- Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.(End of study (Year 3))
- Differential cost-result ratio(End of study (Year 3))
- Occurrence of an early miscarriage between groups(12 weeks of amenorrhea)
- Occurrence of live birth(Upon giving birth (maximum month 9))
