Uterine Microbiome in Recurrent Pregnancy Loss

Sponsor

Mỹ Đức Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05510622

Collaborator

(none)

100

Enrollment

22.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Pregnancy Loss, Not Pregnant Vaginal Microbiome	Other: Vaginal swab and endometrial biopsy

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss

Anticipated Study Start Date :

Aug 20, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Recurrent pregnancy loss Women with history of recurrent pregnancy loss	Other: 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.
Control Normal fertile women	Other: 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.

Arm

Intervention/Treatment

Recurrent pregnancy loss

Women with history of recurrent pregnancy loss

Other: 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.

Control

Normal fertile women

Other: Vaginal swab and endometrial biopsy

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Recurrent pregnancy loss patients

Inclusion Criteria:

18-38 years old
Having a regular menstrual cycle, from 28 to 30 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 28 to 30 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mỹ Đức Hospital

Investigators

Study Chair: Lan N Vuong, MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mỹ Đức Hospital

ClinicalTrials.gov Identifier:

NCT05510622

Other Study ID Numbers:

05/22/DD-BVMD

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Abortion, Spontaneous

Fetal Death

Abortion, Habitual

Recurrence

Study Results

No Results Posted as of Aug 22, 2022