Uterine Microbiome in Recurrent Pregnancy Loss

Mỹ Đức Hospital

Status: Enrolling

Conditions: Recurrent Pregnancy Loss, Not Pregnant; Vaginal Microbiome

Treatments: Other: Vaginal swab and endometrial biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05510622

05/22/DD-BVMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

100 participants in 2 patient groups

Recurrent pregnancy loss

Description:

Women with history of recurrent pregnancy loss

Treatment:

Other: Vaginal swab and endometrial biopsy

Control

Description:

Normal fertile women

Treatment:

Other: Vaginal swab and endometrial biopsy