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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginoses

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Instituto Bernabeu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy oocyte donors

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

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	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 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	qPCR to assess the microbiota. I.e. a quantitative measure Copies/mL. 16S V4 to investigate relative abundances	This outcome data is measured at the 1 day of oocyte retrieval.

Collaborators and Investigators

• Sponsor: Peter Humaidan
• Collaborators: Instituto Bernabeu

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Vaginitis; Vaginosis, Bacterial
• Other Study ID Numbers: Microbiome_endometrial_spain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: WE plan to share all information allowed as per national law.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No