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

Completed
Conditions
Bacterial Vaginoses
Registration Number
NCT04393857
Lead Sponsor
Peter Humaidan
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
26
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.)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Instituto Bernabeu

🇪🇸

Alicante, Spain

Instituto Bernabeu
🇪🇸Alicante, Spain

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