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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03420859
• Other study ID #: 1-16-02-404-16 (datatilsynet)
• Status: Active, not recruiting
• Start date: December 4, 2017
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2023
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1850
• Est. completion date: January 1, 2024
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Abnormal Vaginal Microbiota
• Infertility

Intervention

Diagnostic Test:
• qPCR for abnormal vaginal microbiota
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.)

Locations

Country	Name	City	State
Denmark	Fertility Clinic Skive, Skive Regional Hospital	Skive

Sponsors (6)

Lead Sponsor	Collaborator
Peter Humaidan	Hvidovre Fertility Clinic, Copenhagen, Køge Fertility Clinic, Denmark, Rigshospitalet, Denmark, Statens Serum Institut, Stork Fertility Clinic, VivaNeo, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal vaginal microbiota	qPCR positive diagnosis as described in intervention.	minimum 2-7 days from vaginal swab.
Secondary	Intimate hygiene	questionnaire	2-5 weeks from baseline to embryo transfer
Secondary	Male/partner seminal microbiome	DNA sequencing of seminal samples	2-4 weeks from baseline to oocyte pick-up
Secondary	Number of participants with Clinical pregnancy as measured by heartbeat	Tested by ultrasound scanning in week 7-9.	7-9 weeks after inclusion.
Secondary	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
Secondary	Cumulative live birth rate	The number of live births originating from one controlled ovarian stimulation.	9 months - 24 months after inclusion