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The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes

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ClinicalTrials.gov Identifier: NCT03420859
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Trianglen Fertility Clinic, Copenhagen
Statens Serum Institut
Stork Fertility Clinic, VivaNeo, Copenhagen
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

Brief Summary:
A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT. Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.

Condition or disease Intervention/treatment
Abnormal Vaginal Microbiota Infertility Diagnostic Test: qPCR for abnormal vaginal microbiota

Study Type : Observational
Estimated Enrollment : 1850 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility


Intervention Details:
  • Diagnostic Test: qPCR for abnormal vaginal microbiota
    qPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.)


Primary Outcome Measures :
  1. Abnormal vaginal microbiota [ Time Frame: minimum 2-7 days from vaginal swab. ]
    qPCR positive diagnosis as described in intervention.


Secondary Outcome Measures :
  1. Intimate hygiene [ Time Frame: 2-5 weeks from baseline to embryo transfer ]
    questionnaire

  2. Male/partner seminal microbiome [ Time Frame: 2-4 weeks from baseline to oocyte pick-up ]
    DNA sequencing of seminal samples


Biospecimen Retention:   Samples With DNA
Vaginal swabs


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertile women fulfilling the abovementioned criteria.
Criteria

Inclusion Criteria:

  • First, second or third IVF stimulation cycle at the involved clinic.
  • BMI<30 or a weight loss of 10% and BMI<35.
  • Written informed consent.
  • 18-42 years old

Exclusion Criteria:

  • HIV, Hepatitis B or C positivity.
  • Intrauterine malformations (Vaginal ultrasound)
  • Hysterosalpinx
  • Known severe renal or hepatic impairment.
  • HPV CIN 2 or higher.
  • Patients treated with vitamin K antagonists (warfarin)
  • Known or suspected hypersensitivity to clindamycin or any other antibiotic.
  • Myastenia Gravis
  • Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa
  • Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)

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): NCT03420859


Contacts
Contact: Thor Haahr, MD +4578445760 thohaa@rm.dk
Contact: Peter Humaidan, Professor +4578445760 fertilitetsklinikken@midt.rm.dk

Locations
Denmark
Fertility Clinic Skive, Skive Regional Hospital Recruiting
Skive, Denmark, 7800
Contact: Thor Haahr, MD       thorhaahr@hotmail.com   
Sponsors and Collaborators
Peter Humaidan
Rigshospitalet, Denmark
Trianglen Fertility Clinic, Copenhagen
Statens Serum Institut
Stork Fertility Clinic, VivaNeo, Copenhagen

Responsible Party: Peter Humaidan, Professor, Consultant, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT03420859     History of Changes
Other Study ID Numbers: 1-16-02-404-16 (datatilsynet)
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: By Danish law, we cannot share individual data. But pseudomized data might be available from the National Danish archives. We aim to publish as fully as possible by Danish data protection law.

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female