Uterine Microbiome in Recurrent Pregnancy Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-12

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Recurrent Pregnancy Loss, Not Pregnant Vaginal Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recurrent pregnancy loss

Women with history of recurrent pregnancy loss

Vaginal swab and endometrial biopsy

Intervention Type 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.

Control

Normal fertile women

Vaginal swab and endometrial biopsy

Intervention Type 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.

Interventions

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Vaginal 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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
2. Healthy control patients

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes