NCT05510622

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3.4 years

First QC Date

August 13, 2022

Last Update Submit

September 22, 2025

Conditions

Recurrent Pregnancy Loss, Not PregnantVaginal Microbiome

Keywords

MicrobiomeRecurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

  • Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group

    Bacterial composition in the endometrium in midluteal phase are analysed using 16S rRNA gene sequencing

    1 week

Secondary Outcomes (3)

  • Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group

    1 week

  • Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group

    1 week

  • Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group

    1 week

Study Arms (2)

Recurrent pregnancy loss

Women with history of recurrent pregnancy loss

Other: Vaginal swab and endometrial biopsy

Control

Normal fertile women

Other: Vaginal swab and endometrial biopsy

Interventions

Vaginal swab and endometrial biopsyOTHER

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.

ControlRecurrent pregnancy loss

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

For RPL women: having ≥ 2 recurrent pregnancy loss. For NF women: having ≥ 1 live birth, with no history of pregnancy loss

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

RECRUITING

My Duc Phu Nhuan Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Microbiome analysis using 16S ribosomal RNA sequencing

Study Officials

  • Lan N Vuong, MD, PhD

    University of Medicine and Pharmacy at Ho Chi Minh City

    STUDY CHAIR

Central Study Contacts

Nam T Nguyen, MD

CONTACT

+84354120209bsnam.nt@myduchospital.vn

Tuong M Ho, MD, MCE

CONTACT

(+84) 903 633 377bstuong.hm@myduchospital.vn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 22, 2022

Study Start

December 12, 2022

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

VN(2)