Clinical trial NCT03420859: The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
Official title: The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormal Vaginal Microbiota
Infertility
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Statens Serum Institut
name: Stork Fertility Clinic, VivaNeo, Copenhagen
name: Hvidovre Fertility Clinic, Copenhagen
name: Køge Fertility Clinic, Denmark
First posted: 2018-02-05
Enrollment: 1850
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women fulfilling the abovementioned criteria.

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 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.

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 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Abnormal vaginal microbiota
timeFrame: minimum 2-7 days from vaginal swab.
Secondary outcomes:
measure: Intimate hygiene
timeFrame: 2-5 weeks from baseline to embryo transfer
measure: Male/partner seminal microbiome
timeFrame: 2-4 weeks from baseline to oocyte pick-up
measure: Number of participants with Clinical pregnancy as measured by heartbeat
timeFrame: 7-9 weeks after inclusion.
measure: Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks)
timeFrame: 36-42 weeks after inclusion
measure: Cumulative live birth rate
timeFrame: 9 months - 24 months after inclusion
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic Skive, Skive Regional Hospital
Study officials:
affiliation: The Fertility Clinic Skive
name: Peter Humaidan, Professor
role: PRINCIPAL_INVESTIGATOR
References: