- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393857
The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alicante, Spain
- Instituto Bernabeu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Oocyte donors
Healthy Oocyte donors fulfilling the criteria for oocyte donation are eligible.
Patients may not have received any antibiotics or vaginal products (other than for menstrual hygiene - such as tampons) for the last 1 month.
Informed consent is mandatory.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of ascending infection/sharing of bacteria in the genital tract
Time Frame: This outcome data is measured at the 1 day of oocyte retrieval.
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vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
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This outcome data is measured at the 1 day of oocyte retrieval.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances
Time Frame: This outcome data is measured at the 1 day of oocyte retrieval.
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qPCR to assess the microbiota.
I.e. a quantitative measure Copies/mL.
16S V4 to investigate relative abundances
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This outcome data is measured at the 1 day of oocyte retrieval.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Microbiome_endometrial_spain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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