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NCT Number: NCT05510622

Uterine Microbiome in Recurrent Pregnancy Loss

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.

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

My Duc Hospital, Ho Chi Minh City, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Vaginal swab and endometrial biopsy

Other

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 outcomes

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

    Time frame: 1 week

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

Secondary outcomes

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

    Time frame: 1 week

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

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

    Time frame: 1 week

    Phylogenetic tree based on 16S rRNA gene sequences

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

    Time frame: 1 week

    Phylogenetic tree based on 16S rRNA gene sequences

Study contacts

Contact information is provided by the study sponsor or research team.

Nam T Nguyen, MD

CONTACT

[email protected]

+84354120209

Tuong M Ho, MD, MCE

CONTACT

[email protected]

(+84) 903 633 377

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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