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

NCT03420859 | Unknown

• 1 other identifier: 1-16-02-404-16 (datatilsynet)
• Study Type: observational
• Target: 1,850
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Vaginal Microbiota; Infertility

Outcome Measures

Primary Outcomes (1)

• Abnormal vaginal microbiota

  qPCR positive diagnosis as described in intervention.

  minimum 2-7 days from vaginal swab.

Secondary Outcomes (5)

• Intimate hygiene

  2-5 weeks from baseline to embryo transfer

• Male/partner seminal microbiome

  2-4 weeks from baseline to oocyte pick-up

• Number of participants with Clinical pregnancy as measured by heartbeat

  7-9 weeks after inclusion.

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

  36-42 weeks after inclusion

• Cumulative live birth rate

  9 months - 24 months after inclusion

Interventions

qPCR for abnormal vaginal microbiota DIAGNOSTIC_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 Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile women fulfilling the abovementioned criteria.

You may qualify if:

• First, second or third IVF stimulation cycle at the involved clinic.
• BMI\<35.
• Written informed consent.
• years old

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Peter Humaidan: lead
• Rigshospitalet, Denmark: collaborator
• Statens Serum Institut: collaborator
• Stork Fertility Clinic, VivaNeo, Copenhagen: collaborator
• Hvidovre Fertility Clinic, Copenhagen: collaborator
• Køge Fertility Clinic, Denmark: collaborator

Study Sites (1)

Fertility Clinic Skive, Skive Regional Hospital

Skive, 7800, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swabs

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Peter Humaidan, Professor

  The Fertility Clinic Skive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Consultant

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: February 5, 2018
• Study Start: December 4, 2017
• Primary Completion: August 8, 2023
• Study Completion: January 1, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

DK (1)