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The Temporo-spatial Dynamics of Genital Tract Microbiota

This study is currently recruiting participants.
Verified December 2017 by Peter Humaidan, Regionshospitalet Viborg, Skive
Sponsor:
ClinicalTrials.gov Identifier:
NCT03363828
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Statens Serum Institut
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
  Purpose
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 Intervention
Infertility, Female Drug: Clindamycin Oral Tablet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol

Resource links provided by NLM:


Further study details as provided by Peter Humaidan, Regionshospitalet Viborg, Skive:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances [ Time Frame: 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. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Vaginal, cervical and endometrial. Also semen of patients with male partner.

Estimated Enrollment: 100
Actual Study Start Date: October 1, 2017
Estimated Study Completion Date: June 15, 2019
Estimated Primary Completion Date: January 15, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal microbiota
Based on qPCR and Next gen sequencing
Abnormal microbiota
Based on qPCR and Next gen sequencing
Drug: Clindamycin Oral Tablet
No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infertile couples attending IVF treatment and referred to a segmentation protocol.
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363828


Locations
Denmark
The Fertility Clinic Skive Recruiting
Skive, Denmark, 7800
Contact: Thor Haahr, Bsc    +4527885402    thohaa@rm.dk   
The Fertility Clinic, Regional Hospital of Skive Recruiting
Skive, Denmark, 7800
Contact: Peter S Humaidan, MD    +45 89 27 40 13    peter.humaidan@sygehusviborg.dk   
Contact: Alice T Mikkelsen, Nurse    +45 89 27 40 85      
Principal Investigator: Peter S Humaidan, MD         
Sponsors and Collaborators
Peter Humaidan
Statens Serum Institut
  More Information

Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT03363828     History of Changes
Other Study ID Numbers: 1-10-72-345-15
First Submitted: October 29, 2017
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Part of PhD project. Data will appear in the thesis and subsequent publications.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Clindamycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action