Status:
UNKNOWN
The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
Lead Sponsor:
Peter Humaidan
Collaborating Sponsors:
Rigshospitalet, Denmark
Statens Serum Institut
Conditions:
Abnormal Vaginal Microbiota
Infertility
Eligibility:
FEMALE
18-42 years
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 (EUDRACT 2016-002385-31). Secondary ai...
Detailed Description
At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal va...
Eligibility Criteria
Inclusion
- First, second or third IVF stimulation cycle at the involved clinic.
- BMI\<35.
- Written informed consent.
- 18-42 years old
Exclusion
- 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.)
Key Trial Info
Start Date :
December 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
1850 Patients enrolled
Trial Details
Trial ID
NCT03420859
Start Date
December 4 2017
End Date
January 1 2024
Last Update
April 27 2023
Active Locations (1)
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1
Fertility Clinic Skive, Skive Regional Hospital
Skive, Denmark, 7800