Recurrent Pregnancy Loss, Not PregnantNCT05510622
Uterine Microbiome in Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss, Not Pregnant and Vaginal Microbiome, run by Mỹ Đức Hospital at 2 sites in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Loss, Not Pregnant, Vaginal Microbiome
- What is being tested?
- Vaginal swab and endometrial biopsy
- How many people
- 100 participants
- Where
- 2 sitesVietnam
- Study dates
- 12 Dec 2022to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: For RPL women: having ≥ 2 recurrent pregnancy loss. For NF women: having ≥ 1 live birth, with no history of pregnancy loss
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
- Healthy control patients
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
My Duc Hospital
Ho Chi Minh City, Ho Chi Minh City, 70000
Vu NA Ho, MD, +84935843336, bsvu.hna@myduchospital.vn
Nam T Nguyen, MD, +84354120209, bsnam.nt@myduchospital.vn
- Recruiting
My Duc Phu Nhuan Hospital
Ho Chi Minh City, Ho Chi Minh City, 70000
Ho L Le, MD, +84356177147, bsho.ll@myduchospital.vn
Tien K Le, MD, +84962803875, bstien.lk@myduchospital.vn
About this study
Official title: 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.
Read the 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.
- Being tested
- Vaginal swab and endometrial biopsy
- Keywords
- Microbiome, Recurrent Pregnancy Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swab and endometrial biopsyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent pregnancy loss | Women with history of recurrent pregnancy loss Receives: Other: Vaginal swab and endometrial biopsy | |
| Control | Normal fertile women Receives: Other: Vaginal swab and endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (3)
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
Measured: 1 week
Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group
Phylogenetic tree based on 16S rRNA gene sequences
Measured: 1 week
Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group
Phylogenetic tree based on 16S rRNA gene sequences
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start12 Dec 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss, Not PregnantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Study chair, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510622
- Sponsor's protocol ID
- 05/22/DD-BVMD
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05510622
- Acronym / sponsor ID
- 05/22/DD-BVMD
- Keywords
- Microbiome, Recurrent Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent pregnancy loss | – | Other: Vaginal swab and endometrial biopsyWomen with history of recurrent pregnancy loss |
| Control | – | Other: Vaginal swab and endometrial biopsyNormal fertile women |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For RPL women: having ≥ 2 recurrent pregnancy loss. For NF women: having ≥ 1 live birth, with no history of pregnancy loss
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- Healthy control patients
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal swab and endometrial biopsyA 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. | Other | Control, Recurrent pregnancy loss |
Primary outcome
Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group
Time frame: 1 week
Bacterial composition in the endometrium in midluteal phase are analysed using 16S rRNA gene sequencing
3 secondary outcomes
Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group
Time frame: 1 week
Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group
Time frame: 1 week
Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Recurrent Pregnancy Loss, Not Pregnant
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lan N Vuong, MD, PhD study chair
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss, Not Pregnant and Vaginal Microbiome, run by Mỹ Đức Hospital at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nam T Nguyen, MD (+84354120209, bsnam.nt@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.