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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility; Abnormal Vaginal Microbiota
• Intervention / Treatment: Diagnostic test: qPCR for abnormal 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.

• Study Type: Observational
• Enrollment (Anticipated): 1850

Contacts and Locations

Study Locations

• Denmark
  • Skive, Denmark, 7800
    • Fertility Clinic Skive, Skive Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infertile women fulfilling the abovementioned criteria.

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal vaginal microbiota	qPCR positive diagnosis as described in intervention.	minimum 2-7 days from vaginal swab.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intimate hygiene	questionnaire	2-5 weeks from baseline to embryo transfer
Male/partner seminal microbiome	DNA sequencing of seminal samples	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.	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.	36-42 weeks after inclusion
Cumulative live birth rate	The number of live births originating from one controlled ovarian stimulation.	9 months - 24 months after inclusion

Collaborators and Investigators

• Sponsor: Peter Humaidan
• Collaborators: Rigshospitalet, Denmark; Statens Serum Institut; Stork Fertility Clinic, VivaNeo, Copenhagen; Hvidovre Fertility Clinic, Copenhagen; Køge Fertility Clinic, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Anticipated): August 8, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 28, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1-16-02-404-16 (datatilsynet)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No