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NCT Number: NCT07767240

ERA in Young Primary Infertile RIF Patients

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).

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tb-ERA and personalized embryo transfer

Other

tb-ERA and personalized embryo transfer

Primary outcomes

  1. Ongoing pregnancy

    Time frame: 12 weeks after embryo transfer

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

Secondary outcomes

  1. Clinical pregnancy

    Time frame: 6 to 8 weeks after embryo transfer

    Pregnancy with ultrasound-confirmed intrauterine gestational sac(s)

  2. Implantation rate

    Time frame: 6 to 8 weeks after embryo transfer

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

Other outcomes

  1. Endometrial Receptivity Signature

    Time frame: Through ERA completion, an average of 1 month after sampling

    The proportion of young RIF patients diagnosed with a displaced Window of Implantation (either pre-receptive or post-receptive) based on Endometrial Receptivity Analysis (ERA)

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Li, M.Sc.

CONTACT

86-21-63459977

Yilun Sui, M.D.

CONTACT

[email protected]

86-21-63459977

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

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

Acronym: ERA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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