None
Conditions
Interventions
Normal uterine microbiota group:Conventional endometrial preparation and thawed embryo transfer
Drug intervention group for microbiota dysbiosis:After the end of menstruation in the hormone replacement cycle endometrial preparation protocol or 35 days after the injection of long-acting GnRH agon
Placebo group for microbiota dysbiosis:After the end of menstruation in the hormone replacement cycle endometrial preparation protocol or 35 days after the injection of long-acting GnRH agonists, the
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients meeting the diagnostic criteria for RIF and undergoing frozen-thawed embryo transfer after IVF or ICSI; 2. Married women aged 20-38 years (excluding the boundary values); 3. Married women who have experienced 3 or more failed embryo transfer cycles, with at least one thawed and recovered embryo in previous transfer cycles evaluated as a high-quality embryo (7–8-cell grade I or II Day 3 embryos, or Day 5–6 blastocysts graded 3BB or higher), and with available embryos for transfer; 4. Able to understand the informed consent form, voluntarily participate in this clinical trial, and sign the informed consent; 5. Able to comply with the study protocol and complete the trial.
Exclusion criteria
Exclusion criteria: 1. Women currently receiving any antibiotic, corticosteroid, or immunosuppressive treatment, such as prednisone, methylprednisolone, cyclosporine, tacrolimus, azathioprine, etc. Patients taking these medications require a 2-month washout period before screening; 2. Women known to have autoimmune diseases, such as systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, scleroderma, etc.; 3. Women diagnosed with uterine/tubal conditions that may affect embryo implantation, such as uterine malformations, endometrial polyps, submucosal fibroids, adenomyosis, intrauterine adhesions, untreated hydrosalpinx, etc.; 4. Women or their partners with chromosomal karyotype abnormalities (excluding chromosomal polymorphisms); 5. Women with recurrent miscarriage, defined as two or more clinical pregnancy failures confirmed by ultrasound or histopathological examination; 6. Women with contraindications to assisted reproductive technology and/or pregnancy-related medicine; 7. Patients with thin endometrium (<6mm) who are insensitive or nonresponsive to hormonal medications for endometrial preparation; 8. Patients known to be allergic to lactobacillus vaginal capsules; 9. Patients with acute vaginal/pelvic infections or unexplained vaginal bleeding that make medication use inadvisable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Pregnancy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical Pregnancy Rate;Implantation Rate;Ongoing Pregnancy Rate;Early Miscarriage Rate;Ectopic Pregnancy Rate;Multiple Pregnancy Rate; | — |
Countries
China
Contacts
Public ContactJing Yue
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed