Uterine Microbiome in Recurrent Pregnancy Loss

Reproductive Tract Microbiome in Women With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Microbiome; Recurrent Pregnancy Loss, Not Pregnant
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Hieu LT Hoang, MD; Phone Number: (+84) 969 166 318; Email: bshieu.hlt@gmail.com
• Study Contact Backup: Name: Tuong M Ho, MD, MCE; Phone Number: (+84) 903 633 377; Email: bstuong.hm@myduchospital.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

For RPL women: having ≥ 2 recurrent pregnancy loss. For NF women: having ≥ 1 live birth after spontaneous conception, with no history of pregnancy loss

Description

1. 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
2. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mỹ Đức Hospital
• Investigators: Study Chair: Lan N Vuong, MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 20, 2022
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: August 13, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (ACTUAL): August 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Death; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Fetal Death
• Other Study ID Numbers: 05/22/DD-BVMD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No