ERA in Young Primary Infertile RIF Patients

A Cohort Study of Endometrial Receptivity Analysis in Young, Primary Infertile Patients With Unexplained Recurrent Implantation Failure

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07767240

Acronym

ERA

Enrollment

400

Registered

2026-08-17

Start date

2026-08-15

Completion date

2027-12-31

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Implantation Failure

Keywords

endometrial receptivity analysis, recurrent implantation failure

Brief summary

This study aims to evaluate the clinical efficacy of transcriptome-based endometrial receptivity analysis (tb-ERA) and investigate the molecular mechanisms of abnormal receptivity in young women with unexplained recurrent implantation failure (RIF).

Detailed description

Young women with recurrent implantation failure (RIF) will be prospectively recruited and classified based on their Window of Implantation (WOI) status. Clinical outcomes will be compared between patients undergoing personalized embryo transfer (pET) and those receiving standard transfer. Concurrently, endometrial tissues collected at P+3 and P+5 will undergo RNA sequencing to elucidate the molecular mechanisms underlying abnormal receptivity. Integrating these clinical and transcriptomic data, we aim to develop a clinical prediction model for displaced WOI and validate the efficacy of pET in improving pregnancy outcomes for this specific population.

Interventions

OTHERtb-ERA and personalized embryo transfer

tb-ERA and personalized embryo transfer

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Inclusion criteria

* 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 -

Design outcomes

Primary

Measure	Time frame	Description
Ongoing pregnancy	12 weeks after embryo transfer	Ongoing pregnancy is defined as viable pregnancy beyond 12 weeks' gestation.

Secondary

Measure	Time frame	Description
Clinical pregnancy	6 to 8 weeks after embryo transfer	Pregnancy with ultrasound-confirmed intrauterine gestational sac(s)
Implantation rate	6 to 8 weeks after embryo transfer	The proportion of gestational sacs observed divided by the total number of embryos transferred

Countries

China

Contacts

CONTACTYilun Sui, M.D.

965845006@qq.com86-21-63459977

CONTACTLu Li, M.Sc.

86-21-63459977

PRINCIPAL_INVESTIGATORLu Li, M.Sc.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026