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Recruiting NCT05510622

Uterine Microbiome in Recurrent Pregnancy Loss

— Observational Recurrent Pregnancy Loss, Not Pregnant Vaginal Microbiome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vaginal swab and endometrial biopsy.
Who it may be relevant to
Registry conditions: Recurrent Pregnancy Loss, Not Pregnant, Vaginal Microbiome. Basic parameters: 18 years — 38 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss

Overview

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.

Detailed description

The investigators want to describe the endometrial microbiome composition in normal fertile women and women with a history of recurrent pregnancy loss by analyzing mid-luteal phase vaginal swab and endometrial biopsy samples using 16S rRNA sequencing.

Interventions

  • Other Vaginal 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.

Primary outcome measures

  • Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group [Time frame: 1 week]
Secondary outcome measures (3)
  • Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group [Time frame: 1 week]
  • Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group [Time frame: 1 week]
  • Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group [Time frame: 1 week]

Eligibility criteria

  • Recurrent pregnancy loss patients

Inclusion criteria

  • 18-38 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

Exclusion criteria

  • 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

Inclusion criteria

  • 18-38 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Vietnam · 2 centers
  • My Duc Hospital — Ho Chi Minh City
  • My Duc Phu Nhuan Hospital — Ho Chi Minh City

Identifiers

NCT: NCT05510622 · 05/22/DD-BVMD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗