RecruitingNCT05510622

Uterine Microbiome in Recurrent Pregnancy Loss

Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss


Sponsor

Mỹ Đức Hospital

Enrollment

100 participants

Start Date

Dec 12, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The female genital tract microbiome may reflect female reproductive health and may be related to pregnancy outcomes. Disturbances in this microbiome may be associated with adverse reproductive outcomes. The investigators hypothesize that the endometrial and vaginal microbiome composition in women with a history of recurrent pregnancy loss are different, compared with those in normal fertile women.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 38 Years

Inclusion Criteria12

  • Recurrent pregnancy loss patients
  • years old
  • Having a regular menstrual cycle, from 25 to 35 days
  • Having ≥ 2 recurrent pregnancy loss and
  • Couples with normal karyotype results
  • Having no condition causing pregnancy loss such as antiphospholipid syndrome, abnormal thyroid function.
  • Agree to participate in the study
  • years old
  • Having a regular menstrual cycle, from 25 to 35 days
  • No history of pregnancy loss
  • Having 1 or more live birth, with the youngest child ≥ 6 months old
  • Agree to participate in the study

Exclusion Criteria11

  • Irregular menstrual cycle
  • Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)
  • Using intrauterine device within the last 3 months
  • Using antibiotic/vaginal pessary/contraceptive pills within 2 weeks
  • Having sexual intercourse within 48 hours
  • Healthy control patients
  • Irregular menstrual cycle
  • Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)
  • Using intrauterine device within the last 3 months
  • Using antibiotic/vaginal pessary/contraceptive pills within 2 weeks
  • Having sexual intercourse within 48 hours

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Interventions

OTHERVaginal swab and endometrial biopsy

A vaginal swab (DNA/RNA shield collection tube with swab - Zymo Research, CatNo R1107) and endometrial biopsy (Endobrush® - Lab CCD, Paris, France) will be obtained during 18th - 22nd day of the menstrual cycle.


Locations(2)

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, Vietnam

My Duc Phu Nhuan Hospital

Ho Chi Minh City, Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

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NCT05510622


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