Exploring the Uterine Microbiome in Women with Recurrent Pregnancy Loss
Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss
This study looks at the bacteria in the uterus and vagina of women who have had multiple pregnancy losses to see how it compares to those who have had healthy pregnancies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Mỹ Đức Hospital Academic / other |
| Locations | 2 sites (Ho Chi Minh City, Ho Chi Minh City and 1 other locations) |
| Trial ID | NCT05510622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the endometrial and vaginal microbiome composition in women with a history of recurrent pregnancy loss compared to normal fertile women. Researchers will collect mid-luteal phase vaginal swab and endometrial biopsy samples from participants and utilize 16S rRNA sequencing to identify differences in microbiome profiles. The goal is to understand how disturbances in the microbiome may relate to adverse reproductive outcomes.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-38 with a history of recurrent pregnancy loss and regular menstrual cycles.
Not a fit: Patients with irregular menstrual cycles or uterine abnormalities are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of the microbiome in reproductive health and potentially lead to new therapeutic strategies for women experiencing recurrent pregnancy loss.
How similar studies have performed: While the role of the microbiome in reproductive health is an emerging field, this specific approach of comparing microbiome profiles in recurrent pregnancy loss has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Ho Chi Minh City, Ho Chi Minh City and 1 other locations
- My Duc Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (Recruiting)
- My Duc Phu Nhuan Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Nam T Nguyen, MD
- Email: bsnam.nt@myduchospital.vn
- Phone: +84354120209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.