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

NCT03420859 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1850

Last updated 2023-04-27

No results posted yet for this study

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

Interventions

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.)

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Statens Serum Institut

    collaborator OTHER

  • Stork Fertility Clinic, VivaNeo, Copenhagen

    collaborator UNKNOWN

  • Hvidovre Fertility Clinic, Copenhagen

    collaborator UNKNOWN

  • Køge Fertility Clinic, Denmark

    collaborator UNKNOWN

  • Peter Humaidan

    lead OTHER

Principal Investigators

  • Peter Humaidan, Professor · The Fertility Clinic Skive

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2023-08-08
Completion
2024-01-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03420859 on ClinicalTrials.gov