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

Bacterial Vaginoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393857
• Other study ID #: Microbiome_endometrial_spain
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2021
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginosis, Bacterial

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Peter Humaidan	Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.