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

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.

Conditions

• Recurrent Implantation Failure
• Infertility

Interventions

OTHER

Frozen 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

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital

  collaborator OTHER

• Kwong Wah Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Liuzhou Maternity and Child Healthcare Hospital

  collaborator OTHER

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Ernest HY Ng, MD · The University of Hong Kong

• Song Quan, MD · Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-15

Primary Completion

2027-12-30

Completion

2028-06-30

Countries

• China

Study Locations