A Randomized Controlled Trial Comparing Frozen Embryo Transfer Guided by Endometrial Receptivity Analysis Vs Standard Timing in Patients with Recurrent Implantation Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 734
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The pregnancy rate of in vitro fertilisation (IVF) remains around 35% per transfer. Women who are not pregnant following several embryo transfers are regarded as having recurrent implantation failure (RIF), with one of the causes being the asynchronization of the embryo and endometrium. Endometrial receptivity analysis (ERA) may identify the window of implantation and guide the timing of embryo transfer to improve the pregnancy outcomes. However, there is no randomized controlled trial on the clinical effectiveness of ERA in women with RIF.
This is a multicenter double-blind randomized controlled trial. All participants will have an endometrial biopsy for ERA in a standard hormonal treatment cycle. They will then be randomly assigned in the central laboratory into the intervention or control group in a 1:1 ratio. At the transfer cycle, participants in the intervention group will have frozen embryo transfer timed according to the results of ERA while those in the control group will have the transfer according to the standard timing. The primary outcome is the ongoing pregnancy rate at 10-12 weeks at their first frozen embryo transfer.
详细描述
Trial design This is a multicenter randomized double-blind controlled trial evaluating the clinical effectiveness of ERA-guided frozen embryo transfer in improving the pregnancy rate of infertile women with RIF. All participants will first undergo a biopsy cycle to obtain an endometrial biopsy for ERA and will then be randomly assigned into the intervention or control group. At the transfer cycle, participants in the intervention group will have frozen embryo transfer timed according to the ERA result while those in the control group will have frozen embryo transfer according to standard timing.
Screening, recruitment and consent Women with RIF will be recruited from 10 hospitals across China. Recurrent implantation failure is defined as failure to achieve pregnancy after three embryo transfer of both fresh and frozen embryos.3 The inclusion and exclusion criteria is summarized in Table 1.
Table 1. Inclusion and exclusion criteria Inclusion criteria
- Women with RIF
- Women aged < 40 years
- Body mass index of women between 18.5 (inclusive) and 30 (exclusive) kg/m²
- Women with at least one high quality frozen blastocyst (BB grade or above) and planning to undergo a single blastocyst transfer
- Women who will give written informed consent
Exclusion Criteria
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with recurrent implantation failure
- •Women aged < 40 years
- •Body mass index of women between 18.5 (inclusive) and 30 (exclusive) kg/m²
- •Women with at least one high quality frozen blastocyst (BB grade or above) and planning to undergo a single blastocyst transfer
- •Women who will give written informed consent
排除标准
- •Women with recurrent pregnancy loss (3 or more biochemical or spontaneous miscarriages)
- •Either partner with known chromosomal abnormalities including balanced translocations
- •Women undergoing preimplantation genetic testing
- •Women with endometrial thickness < 7 mm in the IVF cycle
- •Women with a confirmed diagnosis of stage III-IV endometriosis or adenomyosis affecting uterine cavity morphology
- •Women with a confirmed diagnosis of antiphospholipid syndrome
- •Pathologies affecting the uterine cavity, including polyps, submucosal fibroids, intramural fibroids > 4 cm, or hydrosalpinx
研究组 & 干预措施
ERA group
The timing of frozen embryo transfer will be arranged according to the endometrial receptivity analysis result
干预措施: Frozen embryo transfer according to endometrial receptivity analysis result (Other)
Control group
Frozen embryo transfer will be arranged according to standard timing, i.e. after 5 days of consecutive progesterone use
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 8-10 weeks after embryo transfer
Pregnancy with fetal pulsation at 10-12 weeks
次要结局
- Mode of delivery(Until one week postpartum)
- Live birth rate(Until one week postpartum)
- Endometrial receptivity status(4 weeks after endometrial biopsy)
- Biochemical pregnancy rate(14 days after embryo transfer)
- Clinical pregnancy rate(At 5th week of pregnancy)
- Biochemical miscarriage rate(At 5th week of pregnancy)
- Early miscarriage rate(up to 13 weeks of pregnancy)
- Placental abruption(Until one week postpartum)
- Ectopic pregnancy rate(Till the end of pregnancy)
- Gestational diabetes mellitus(Until one week postpartum)
- Preeclampsia(Until one week postpartum)
- Placenta previa(Until one week postpartum)
- Gestational age(Until one week postpartum)
- Birth weight(Until one week postpartum)
- Apgar scores(Until one week postpartum)
- Preterm rate(Until one week postpartum)
- Malformation rate(Until one week postpartum)
- Neonatal mortality rate(Until 28 days after delivery)
研究者
Professor Ernest Hung-Yu Ng
Clinical Professor
The University of Hong Kong