Health TrialsbyHealthPanel

ERA in Young Primary Infertile RIF Patients

ConditionRecurrent Implantation Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorShangHai Ji Ai Genetics & IVF Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

RIF Cohort - 1. 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.

Disqualifiers

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).

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • tb-ERA and personalized embryo transfer

    Other intervention

    tb-ERA and personalized embryo transfer

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: ERA cohort1 intervention
Group B: Active Comparator0 interventions
Group C: Control0 interventions

Trial outcomes

Primary outcomes

1

Ongoing pregnancy

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

Time frame
12 weeks after embryo transfer

Secondary outcomes

1

Clinical pregnancy

Pregnancy with ultrasound-confirmed intrauterine gestational sac(s)

Time frame
6 to 8 weeks after embryo transfer
2

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

Other outcomes

1

Endometrial Receptivity Signature

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)

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ShangHai Ji Ai Genetics & IVF Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: