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

Peter Humaidan

Status: Completed

Conditions: Bacterial Vaginoses

Study type: Observational

Funder types: Other

Identifiers

NCT04393857

Microbiome_endometrial_spain

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

26 participants in 1 patient group

Oocyte donors

Description:

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.