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Can a genetic test on the uterine lining solve the mystery of repeated IVF failure?

NCT ID NCT07767240

Knowledge-focused Sponsor: ShangHai Ji Ai Genetics & IVF Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study is looking at whether a test called transcriptome-based endometrial receptivity analysis (tb-ERA) can help young women who have had multiple failed embryo transfers despite having high-quality embryos. The test analyzes the uterine lining to find the best time for embryo transfer. The goal is to see if this personalized approach can improve the chances of a successful pregnancy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcriptome-based endometrial receptivity analysis (tb-ERA) and personalized embryo transfer
What this could lead to
If successful, this could lead to a more precise method for timing embryo transfer, potentially improving pregnancy rates in women with recurrent implantation failure.
What could go wrong
This is a cohort study, not a randomized trial, so results may be influenced by confounding factors. The test's clinical utility and cost-effectiveness are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll women aged ≤ 35 years with a BMI of 18-25 kg/m². The RIF cohort includes patients with primary infertility and ≥ 3 failed transfers of high-quality embryos, further divided into the RIF-ERA group and the RIF non-ERA group (active comparator). The control group consists of patients undergoing their first IVF-ET cycle for tubal factor infertility, with no history of biochemical pregnancy or miscarriage. Patients with known causes of implantation failure will be excluded from all groups. All participants will provide written informed consent.

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* RIF Cohort - Inclusion Criteria 1. Age ≤ 35 years; BMI 18-25 kg/m². 2. ≥ 3 failed transfers of high-quality embryos. 3. No history of spontaneous or FET-related pregnancy, including biochemical pregnancy (primary infertility). 4. Written informed consent provided. * RIF Cohort - Exclusion Criteria 1. Known factors associated with RIF, including: uterine anatomical abnormalities (malformations, adhesions, polyps, submucosal fibroids, adenomyosis) and hydrosalpinx 2. Endocrine disorders (PCOS, thyroid dysfunction, hyperprolactinemia) 3. Reproductive immunological abnormalities, thrombophilia and infectious factors, abnormal semen parameters, 4. Chromosomal abnormalities in either partner (planned PGT-SR) or monogenic disease (planned PGT-M). 5. Severe medical/surgical conditions contraindicating pregnancy. 6. Any other condition deemed unsuitable by the investigators. * Control Group - Inclusion Criteria 1. Age ≤ 35 years; BMI 18-25 kg/m². 2. First IVF-ET cycle due to tubal factor infertility. 3. No history of biochemical pregnancy or miscarriage. 4. Written informed consent provided. * Control Group - Exclusion Criteria 1. Same as RIF Cohort Exclusion Criteria. Additionally, participants with an abnormal ERA result will be excluded from the control group.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent implantation failure

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200011, China

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