ERA in Young Primary Infertile RIF Patients

N/ANot Yet RecruitingNCT07767240

ShangHai Ji Ai Genetics & IVF Institute400 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Recurrent Implantation Failure

Interventions

tb-ERA and personalized embryo transferOTHER

tb-ERA and personalized embryo transfer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

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

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Ongoing pregnancy

Ongoing pregnancy is defined as viable pregnancy beyond 12 weeks' gestation.

Time frame: 12 weeks after embryo transfer

Secondary Outcomes

Clinical pregnancy

Pregnancy with ultrasound-confirmed intrauterine gestational sac(s)

Time frame: 6 to 8 weeks after embryo transfer

Implantation rate

The proportion of gestational sacs observed divided by the total number of embryos transferred

Time frame: 6 to 8 weeks after embryo transfer

Central Contacts

Yilun Sui, M.D.

CONTACT

86-21-63459977 965845006@qq.com

Lu Li, M.Sc.

CONTACT

86-21-63459977

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.