Last updated: January 30, 2021
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Recurrent Pregnancy Loss
Infertility
Treatment
N/AClinical Study ID
NCT04293068
2020Microbiota
Ages 18-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The sampling cycle of all samples requires no use of glucocorticoids, antibiotics andvaginal drugs within the cycle of this month; No cervical treatment within a week; Noirrigation, asexual life within 5 days; Strict contraception in this month;
- Male infertility (Related tests were normal, because the male factor alone requiredthe first IVF/ICSI cycle; Follow-up of included patients was conducted to determinewhether embryo transplantation was performed, and the score of transferred embryos wasrecorded, and the final control group would be confirmed after achieving clinicalpregnancy) OR Recurrent implantation failure (Previous ≥3 consecutive embryo transferfailures) OR Recurrent spontaneous abortion (≥2 consecutive spontaneous abortions orembryo damage)
Exclusion
Exclusion Criteria:
- Acute genital tract inflammation (including vagina, cervix, endometrium and pelviccavity)
- Previous diagnosis of intrauterine adhesion or mechanical damage to the endometrium;drugs and surgery can not restore the function (endometrium thickness <7mm in thewindow period before transplantation)
- Untreated hydrosalpinx, submucosal or >4cm intramuscular uterine fibroids,adenomyosis, stage III-IV endometriosis confirmed by surgery, endometritis diagnosedby pathology and other definite factors might affect implantation
- Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation andother diseases
- Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/mland/or AFC≤5-7)
- Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders
- Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes,metabolic syndrome and other endocrine and metabolic diseases
- BMI less than 18 or more than 25
- Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren'ssyndrome and rheumatoid arthritis
- Prethrombotic hypercoagulability or family history of thrombosis
- Female genital tract deformities (whether or not surgically corrected)
- Those within the programme of oocyte or sperm donor
- Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases
Study Design
Total Participants: 120
Study Start date:
August 18, 2020
Estimated Completion Date:
December 31, 2021
Study Description
Connect with a study center
Peking university third hospital
Beijing, Beijing 100191
ChinaActive - Recruiting
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