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A new method of assessing endometrial receptivity using triple testing (biota-inflammation-gene): a multicenter, prospective, randomized controlled trial

A new method of assessing endometrial receptivity using triple testing (biota-inflammation-gene): a multicenter, prospective, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113818
Enrollment
Unknown
Registered
2025-12-03
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Infertility

Interventions

Study Group:Participants will receive treatment for endometritis and adjustment of the endometrial microbiota simultaneously based on the results and recommendations of pathological and endometrial mi
Control Group:Participants will receive conventional treatment for endometritis based solely on pathological results in accordance with clinical routine. After medication, they will undergo frozen-tha

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients who have undergone 1–2 cycles of IVF/ICSI-ET and have not achieved clinical pregnancy. Those diagnosed with endometritis by hysteroscopic endometrial biopsy and with abnormal endometrial microbiota assessment; 2. Patients who have been informed and have signed the informed consent form for the RCT trial; 3. Patients with at least two good-quality embryos cryopreserved by vitrification; 4. Body mass index (BMI): 18.5 (inclusive)–30.0 kg/m^2 (inclusive); 5. Patients with normal ovarian reserve before the start of controlled ovarian stimulation (defined as: AFC >= 8; FSH < 8 mU/ml); 6. Patients with serum P level <= 1.5 ng/ml measured within 24 hours before hCG injection during the controlled ovarian stimulation cycle; 7. Patients with negative serological tests for HIV, HBV, HCV, and RPR.

Exclusion criteria

Exclusion criteria: 1. Patients with recurrent miscarriages (>2 biochemical pregnancies or >2 spontaneous abortions); 2. Patients with severe male factor infertility (sperm count 4cm, or hydrosalpinx, must have undergone surgery 3 months prior to endometrial sample collection. (Note: Patients whose pathological lesions have been treated before enrollment are still eligible to participate in the study.) 5. Patients who have undergone preimplantation genetic testing for aneuploidy (PGT-A) for embryo analysis; 6. Women who have received antibiotic treatment within one month prior to sample collection, excluding treatment for oocyte retrieval. Patients who require antibiotic treatment due to illness during the embryo transfer cycle; 7. Patients with any unstable or medical conditions that may affect patient safety and study compliance.

Design outcomes

Primary

MeasureTime frame
clinical pregnancy rate;live birth rate;

Secondary

MeasureTime frame
miscarriage rate;Ectopic Pregnancy Rate;

Countries

China

Contacts

Public ContactYang Shuo

Peking University Third Hospital

yangshuo@263.net+86 138 1034 9928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026