Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI

Last updated: January 30, 2021
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Recurrent Pregnancy Loss

Infertility

Treatment

N/A

Clinical Study ID

NCT04293068
2020Microbiota
  • Ages 18-40
  • Female

Study 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 correlation between reproductive tract microbiota and IVF/ICSI outcomes. Whether there are differences in reproductive tract microbiota (such as vagina, follicular fluid, uterine cavity, etc.) in patients with different pregnancy outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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;
  2. 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:

  1. Acute genital tract inflammation (including vagina, cervix, endometrium and pelviccavity)
  2. 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)
  3. 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
  4. Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation andother diseases
  5. Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/mland/or AFC≤5-7)
  6. Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders
  7. Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes,metabolic syndrome and other endocrine and metabolic diseases
  8. BMI less than 18 or more than 25
  9. Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren'ssyndrome and rheumatoid arthritis
  10. Prethrombotic hypercoagulability or family history of thrombosis
  11. Female genital tract deformities (whether or not surgically corrected)
  12. Those within the programme of oocyte or sperm donor
  13. 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

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 abortion. The study will last for 1 year and recruit participants in Reproductive medicine center of Peking university third hospital. Each participant will be followed up for at least 1 year. Collect samples and record information at the first month, then follow-up 2 months to record the pregnancy outcomes. DNA will be extracted from the samples and then have sequence to figure out the compositions of microbiota.

Connect with a study center

  • Peking university third hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

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