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

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.

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Key information

Conditions

Bacterial Vaginoses Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Bernabeu

Alicante, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

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.

vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.

Secondary outcomes

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.

qPCR to assess the microbiota. I.e. a quantitative measure Copies/mL. 16S V4 to investigate relative abundances

Sponsors and collaborators

Lead sponsor

Peter Humaidan

Other

Collaborators

Instituto Bernabeu

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 19, 2020
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed