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

N/AUnknownNCT03420859

Peter Humaidan1,850 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,850

Conditions

Abnormal Vaginal Microbiota Infertility

Interventions

qPCR for abnormal vaginal microbiotaDIAGNOSTIC_TEST

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.)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Fertility Clinic Skive, Skive Regional Hospital

Skive, Denmark

Outcomes

Primary Outcomes

Abnormal vaginal microbiota

qPCR positive diagnosis as described in intervention.

Time frame: minimum 2-7 days from vaginal swab.

Secondary Outcomes

Intimate hygiene

questionnaire

Time frame: 2-5 weeks from baseline to embryo transfer

Male/partner seminal microbiome

DNA sequencing of seminal samples

Time frame: 2-4 weeks from baseline to oocyte pick-up

Number of participants with Clinical pregnancy as measured by heartbeat

Tested by ultrasound scanning in week 7-9.

Time frame: 7-9 weeks after inclusion.

Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks)

Tested by self-reported schemes mailed to the clinics.

Time frame: 36-42 weeks after inclusion

Cumulative live birth rate

The number of live births originating from one controlled ovarian stimulation.

Time frame: 9 months - 24 months after inclusion

Data from ClinicalTrials.gov

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