Status:
UNKNOWN
Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI
Lead Sponsor:
Peking University Third Hospital
Conditions:
Infertility
Recurrent Implantation Failure
Eligibility:
FEMALE
18-40 years
Brief Summary
A single center，observational cohort study to explore the relationship between reproductive tract microbiota and pregnancy outcome in the patients accepted IVF/ICSI. To investigate whether there is a ...
Detailed Description
A single center，observational cohort study will enroll 120 infertile participants and then divide them into 3 groups: 1)Male infertility；2)Recurrent implantation failure; 3)Recurrent spontaneous abort...
Eligibility Criteria
Inclusion
- The sampling cycle of all samples requires no use of glucocorticoids, antibiotics and vaginal drugs within the cycle of this month; No cervical treatment within a week; No irrigation, asexual life within 5 days; Strict contraception in this month;
- Male infertility (Related tests were normal, because the male factor alone required the first IVF/ICSI cycle; Follow-up of included patients was conducted to determine whether embryo transplantation was performed, and the score of transferred embryos was recorded, and the final control group would be confirmed after achieving clinical pregnancy) OR Recurrent implantation failure (Previous ≥3 consecutive embryo transfer failures) OR Recurrent spontaneous abortion (≥2 consecutive spontaneous abortions or embryo damage)
Exclusion
- Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity)
- Previous diagnosis of intrauterine adhesion or mechanical damage to the endometrium; drugs and surgery can not restore the function (endometrium thickness \<7mm in the window period before transplantation)
- Untreated hydrosalpinx, submucosal or \>4cm intramuscular uterine fibroids, adenomyosis, stage III-IV endometriosis confirmed by surgery, endometritis diagnosed by pathology and other definite factors might affect implantation
- Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases
- Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/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's syndrome 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
Key Trial Info
Start Date :
August 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04293068
Start Date
August 18 2020
End Date
December 1 2021
Last Update
February 2 2021
Active Locations (1)
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1
Peking university third hospital
Beijing, Beijing Municipality, China, 100191