The Temporo-spatial Dynamics of Genital Tract Microbiota

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Estrofem

• Registration Number: NCT03363828
• Lead Sponsor: Peter Humaidan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-06
• Primary Completion: 2019-09-23
• Study Completion: 2021-01-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abnormal microbiota	Estrofem	Based on qPCR and Next gen sequencing

Primary Outcome Measures

Name	Time	Method
Rate of ascending infection/sharing of bacteria in the genital tract	This outcome data is measured at the day of oocyte retrieval.	Seminal, vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.

Secondary Outcome Measures

Name	Time	Method
Number of participants with a Clinical pregnancy	7-9 weeks after inclusion.	Tested by clinical pregnancy scan by ultrasound in week 7-9
Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances	Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.	Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.
qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.	Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.	Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.
Number of participants with a Live birth	36-42 weeks after inclusion	Tested by self-reported schemes

Trial Locations

Locations (2)

The Fertility Clinic, Regional Hospital of Skive; 🇩🇰 Skive, Denmark

The Fertility Clinic Skive; 🇩🇰 Skive, Denmark