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

Peter Humaidan

Status: Active, not recruiting

Conditions: Infertility; Abnormal Vaginal Microbiota

Treatments: Diagnostic Test: qPCR for abnormal vaginal microbiota

Study type: Observational

Funder types: Other

Identifiers

NCT03420859

1-16-02-404-16 (datatilsynet)

Details and patient eligibility

About

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 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.

Full 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 vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.

Enrollment: 1,850 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First, second or third IVF stimulation cycle at the involved clinic.
• 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.)