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The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors

The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04393857
Enrollment
26
Registered
2020-05-19
Start date
2020-05-15
Completion date
2020-07-01
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginoses

Brief summary

The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.

Interventions

None listed

Sponsors

Instituto Bernabeu
CollaboratorOTHER
Peter Humaidan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle

Exclusion criteria

Antibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity. Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)

Design outcomes

Primary

MeasureTime frameDescription
Rate of ascending infection/sharing of bacteria in the genital tractThis outcome data is measured at the 1 day of oocyte retrieval.vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.

Secondary

MeasureTime frameDescription
Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundancesThis outcome data is measured at the 1 day of oocyte retrieval.qPCR to assess the microbiota. I.e. a quantitative measure Copies/mL. 16S V4 to investigate relative abundances

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026