NCT07576361

Brief Summary

Endometriosis is a chronic disease, of which the pathophysiology is still unknown. Several theories exist, the one of menstrual blood flow has been retained until now but does not fully explain it. The main symptoms are dysmenorrhea, dyspareunia and infertility. The aim of this study is to evaluate the impact of c.albicans colonization of vaginal microbioma in development of endometriosis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

C.Albicansdysbiosisendometriosisinflammation

Outcome Measures

Primary Outcomes (1)

  • vaginal dysbiosis with C. albicans

    comparison of percentages between the two groups

    At inclusion

Secondary Outcomes (4)

  • correlation between vaginal dysbioses and the presence of Candida hyphae

    At inclusion

  • impact of endometriosis on HPVhr carrying

    At inclusion

  • inflammatory biological markers involved in the endometriotic process

    At inclusion

  • inflammatory biological markers involved in the endometriotic process

    At inclusion

Study Arms (2)

case

Patient with confirmed or highly suspected endometriosis

Control

No confirmed or highly suspected endometriosis

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women aged 18-50 years old

You may qualify if:

  • For cases :
  • aged 18-50 years old With confirmed or highly suspected endometriosis Affiliated to a social security system For controls: -aged 18-50 years old No confirmed or highly suspected Affiliated to a social security system

You may not qualify if:

  • Minors; Pregnant women; Protected persons, or persons placed under the protection of justice; Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloupe

Les Abymes, Guadeloupe, 97159, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

vaginal samples, buccal samples

MeSH Terms

Conditions

EndometriosisDysbiosisInflammation

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GÜLEN AYHAN, Doctor

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

November 25, 2020

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations