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

NCT06762626 | Recruiting DMC

• 1 other identifier: HERA China
• Study Type: interventional
• Target: 734
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endometrial receptivity analysis; ERA; RIF; Recurrent implantation failure; frozen embryo transfer; FET

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Pregnancy with fetal pulsation at 10-12 weeks

  8-10 weeks after embryo transfer

Secondary Outcomes (18)

• 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

Study Arms (2)

ERA group

EXPERIMENTAL

The timing of frozen embryo transfer will be arranged according to the endometrial receptivity analysis result

Other: Frozen embryo transfer according to endometrial receptivity analysis result

Control group

NO INTERVENTION

Frozen embryo transfer will be arranged according to standard timing, i.e. after 5 days of consecutive progesterone use

Interventions

Frozen embryo transfer according to endometrial receptivity analysis result OTHER

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

ERA group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• 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

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Ernest HY Ng, MD

  The University of Hong Kong

  STUDY DIRECTOR

• Song Quan, MD

  Southern Medical University

  STUDY CHAIR

Central Study Contacts

Ernest HY Ng, MD

CONTACT

+85222553400; nghye@hku.hk

Catherine Hung, MBBS

CONTACT

+85296148198; catherinehmw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 7, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the main results
• Access Criteria: Reasonable request for academic purposes

Locations

CN (1)