The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
- 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
Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle
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
Name Time Method Rate of ascending infection/sharing of bacteria in the genital tract This 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
Name Time Method Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances This 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