Uterine Microbiome in Recurrent Pregnancy Loss

Vaginal Microbiome Clinical Trial

Official title:

Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510622
• Other study ID #: 05/22/DD-BVMD
• Status: Recruiting
• Start date: December 12, 2022
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: M? Ð?c Hospital
• Contact: Nam T Nguyen, MD
• Phone: +84354120209
• Email: bsnam.nt[@]myduchospital.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrence
• Vaginal Microbiome

Intervention

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.

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City
Vietnam	My Duc Phu Nhuan Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group	Phylogenetic tree based on 16S rRNA gene sequences	1 week
Secondary	Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group	Phylogenetic tree based on 16S rRNA gene sequences	1 week