The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol
Overview
- Phase
- Not Applicable
- Intervention
- Estrofem
- Conditions
- Infertility, Female
- Sponsor
- Peter Humaidan
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Rate of ascending infection/sharing of bacteria in the genital tract
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Peter Humaidan
Professor
Regionshospitalet Viborg, Skive
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.)
Arms & Interventions
Abnormal microbiota
Based on qPCR and Next gen sequencing
Intervention: Estrofem
Outcomes
Primary Outcomes
Rate of ascending infection/sharing of bacteria in the genital tract
Time Frame: 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 Outcomes
- Number of participants with a Clinical pregnancy(7-9 weeks after inclusion.)
- 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.)
- 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.)
- Number of participants with a Live birth(36-42 weeks after inclusion)