RecruitingNot ApplicableNCT06762626

Comparing FET Guided by ERA Vs Standard Timing in Patients with Recurrent Implantation Failure

A Randomized Controlled Trial Comparing Frozen Embryo Transfer Guided by Endometrial Receptivity Analysis Vs Standard Timing in Patients with Recurrent Implantation Failure


Sponsor

The University of Hong Kong

Enrollment

734 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria5

  • 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

Exclusion Criteria7

  • 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

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Interventions

OTHERFrozen embryo transfer according to endometrial receptivity analysis result

Frozen embryo transfer will be arranged according to endometrial receptivity analysis result, which will be shown in the form of P+X hours


Locations(1)

The University of Hong Kong

Hong Kong, China

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NCT06762626


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