Health TrialsbyHealthPanel

Uterine Microbiome in Recurrent Pregnancy Loss

ConditionsRecurrent Pregnancy Loss, Not PregnantVaginal Microbiome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-38
SponsorMỹ Đức Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Recurrent pregnancy loss patients

18-38 years old

Having a regular menstrual cycle, from 25 to 35 days

Having ≥ 2 recurrent pregnancy loss and

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Vaginal swab and endometrial biopsy

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Recurrent pregnancy loss1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 week

Secondary outcomes

1

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

Time frame
1 week
2

Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group

Phylogenetic tree based on 16S rRNA gene sequences

Time frame
1 week
3

Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group

Phylogenetic tree based on 16S rRNA gene sequences

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mỹ Đức Hospital

Lead sponsor

Source ClinicalTrials.gov
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