Skip to content

Uterine Microbiome in Recurrent Pregnancy Loss

Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05510622
Enrollment
100
Registered
2022-08-22
Start date
2022-12-12
Completion date
2026-05-31
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Pregnancy Loss, Not Pregnant, Vaginal Microbiome

Keywords

Microbiome, Recurrent Pregnancy Loss

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.

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

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.

Sponsors

Mỹ Đức Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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 2. 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

Design outcomes

Primary

MeasureTime frameDescription
Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group1 weekBacterial composition in the endometrium in midluteal phase are analysed using 16S rRNA gene sequencing

Secondary

MeasureTime frameDescription
Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group1 weekBacterial composition in the vaginal in midluteal phase are analysed using 16S rRNA gene sequencing
Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group1 weekPhylogenetic tree based on 16S rRNA gene sequences
Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group1 weekPhylogenetic tree based on 16S rRNA gene sequences

Countries

Vietnam

Contacts

Primary ContactNam T Nguyen, MD
bsnam.nt@myduchospital.vn+84354120209
Backup ContactTuong M Ho, MD, MCE
bstuong.hm@myduchospital.vn(+84) 903 633 377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026