Clinical trial NCT05510622: Uterine Microbiome in Recurrent Pregnancy Loss
Official title: Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Pregnancy Loss, Not Pregnant
Vaginal Microbiome
Keywords: Microbiome
Recurrent Pregnancy Loss
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For RPL women: having ≥ 2 recurrent pregnancy loss. For NF women: having ≥ 1 live birth, with no history of pregnancy loss

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.

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.

Eligibility 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

Primary outcomes:
measure: Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group
timeFrame: 1 week
Secondary outcomes:
measure: Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group
timeFrame: 1 week
measure: Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group
timeFrame: 1 week
measure: Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group
timeFrame: 1 week
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Phu Nhuan Hospital
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Lan N Vuong, MD, PhD
role: STUDY_CHAIR
References: