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

NCT04393857 | Completed

• 1 other identifier: Microbiome_endometrial_spain
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginoses

Outcome Measures

Primary Outcomes (1)

• Rate of ascending infection/sharing of bacteria in the genital tract

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

  This outcome data is measured at the 1 day of oocyte retrieval.

Secondary Outcomes (1)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy oocyte donors

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Peter Humaidan: lead
• Instituto Bernabeu: collaborator

Study Sites (1)

Instituto Bernabeu

Alicante, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal, Cervical and endometrial samples taken with the Eswab (Copan), eNAT (Copan) and Tao brush (Cook medical). Although there will be Human DNA in samples, we aim to isolate bacterial DNA for further analysis. No analyses are planned on Human DNA.

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Consultant

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: May 15, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

ES (1)