The Temporo-spatial Dynamics of Genital Tract Microbiota
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Normal microbiota Based on qPCR and Next gen sequencing |
|
| Abnormal microbiota Based on qPCR and Next gen sequencing |
Drug: Estrofem
Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Clinical pregnancy [7-9 weeks after inclusion.]
Tested by clinical pregnancy scan by ultrasound in week 7-9
- Number of participants with a Live birth [36-42 weeks after inclusion]
Tested by self-reported schemes
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients in IVF Freeze-all/segmentation treatment protocol.
-
Written informed consent.
Exclusion Criteria:
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Uterine malformations
-
HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
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Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Fertility Clinic Skive | Skive | Denmark | 7800 | |
| 2 | The Fertility Clinic, Regional Hospital of Skive | Skive | Denmark | 7800 |
Sponsors and Collaborators
- Peter Humaidan
- Statens Serum Institut
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1-10-72-345-15