About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Frozen embryo transfer according to endometrial receptivity analysis result
Other interventionFrozen embryo transfer will be arranged according to endometrial receptivity analysis result, which will be shown in the form of P+X hours
Treatment groups
Trial outcomes
Primary outcomes
Ongoing pregnancy rate
Pregnancy with fetal pulsation at 10-12 weeks
Secondary outcomes
Endometrial receptivity status
Number of participants showing out of phase endometrium
Biochemical pregnancy rate
Number of patients with serum β-hCG ≥ 25 mIU/ml 14 days after embryo transfer / Number of patients who underwent embryo transfer \* 100%
Clinical pregnancy rate
Number of patients with an intrauterine gestational sac on transvaginal ultrasound at the 5th week of pregnancy / Number of patients who underwent embryo transfer \* 100%
Biochemical miscarriage rate
Number of patients with serum β-hCG ≥ 25 mIU/ml at the 5th week of pregnancy but without a gestational sac on transvaginal ultrasound / Number of biochemical pregnancies \* 100%
Sponsors and contacts
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The University of Hong Kong
Lead sponsor
The University of Hong Kong-Shenzhen Hospital
Collaborator
Kwong Wah Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Liuzhou Maternity and Child Healthcare Hospital
Collaborator
Third Affiliated Hospital of Zhengzhou University
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator