The Temporo-spatial Dynamics of Genital Tract Microbiota

NCT ID: NCT03363828

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-01-08

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 semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.

Conditions

Infertility, Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal microbiota

Based on qPCR and Next gen sequencing

No interventions assigned to this group

Abnormal microbiota

Based on qPCR and Next gen sequencing

Estrofem

Intervention Type: DRUG

Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment

Interventions

Estrofem

Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients in IVF Freeze-all/segmentation treatment protocol.
• Written informed consent.

Exclusion Criteria

• Uterine malformations
• 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Statens Serum Institut

OTHER

Sponsor Role: collaborator

Peter Humaidan

OTHER

Sponsor Role: lead

Responsible Party

Peter Humaidan

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Fertility Clinic Skive

Skive, , Denmark

The Fertility Clinic, Regional Hospital of Skive

Skive, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-345-15

Identifier Type: -

Identifier Source: org_study_id