Uterine Microbiome in Recurrent Pregnancy Loss

Recruiting

• Conditions: Recurrent Pregnancy Loss, Not Pregnant; Vaginal Microbiome
• Interventions: Other: Vaginal swab and endometrial biopsy

• Registration Number: NCT05510622
• Lead Sponsor: Mỹ Đức Hospital

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.

Study Timeline

• Study First Submitted: 2022-08-13
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-12-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recurrent pregnancy loss	Vaginal swab and endometrial biopsy	Women with history of recurrent pregnancy loss
Control	Vaginal swab and endometrial biopsy	Normal fertile women

Primary Outcome Measures

Name	Time	Method
Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group	1 week	Bacterial composition in the endometrium in midluteal phase are analysed using 16S rRNA gene sequencing

Secondary Outcome Measures

Name	Time	Method
Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group	1 week	Phylogenetic tree based on 16S rRNA gene sequences
Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group	1 week	Phylogenetic tree based on 16S rRNA gene sequences
Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group	1 week	Bacterial composition in the vaginal in midluteal phase are analysed using 16S rRNA gene sequencing

Trial Locations

Locations (2)

My Duc Phu Nhuan Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Vietnam