Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT06762626

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

Led by The University of Hong Kong · Updated on 2025-03-26

734

Participants Needed

1

Research Sites

175 weeks

Total Duration

On this page

Sponsors

T

The University of Hong Kong

Lead Sponsor

T

The University of Hong Kong-Shenzhen Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with recurrent implantation failure
  • Women aged < 40 years
  • Body mass index between 18.5 (inclusive) and 30 (exclusive) kg/m²
  • At least one high quality frozen blastocyst (BB grade or above) planned for single blastocyst transfer
  • Women who will provide written informed consent
Not Eligible

You will not qualify if you...

  • 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 diagnosed with stage III-IV endometriosis or adenomyosis affecting uterine cavity morphology
  • Women diagnosed with antiphospholipid syndrome
  • Uterine pathologies including polyps, submucosal fibroids, intramural fibroids > 4 cm, or hydrosalpinx

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Hong Kong

Hong Kong, China

Actively Recruiting

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Research Team

E

Ernest HY Ng, MD

CONTACT

C

Catherine Hung, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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