NCT07000786

Brief Summary

This study investigates epigenetic changes in menstrual effluent and plasma from women with endometriosis to identify potential non-invasive diagnostic biomarkers for the disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
44mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
May 2025Dec 2029

First Submitted

Initial submission to the registry

May 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

4.6 years

First QC Date

May 12, 2025

Last Update Submit

June 2, 2025

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

  • Epigenetic analysis

    Histone post-translational modifications

    Throughout the entire study, approximately during 3,5 years

  • Epigenetic analysis

    miRNA

    Throughout the entire study, approximately during 3,5 years

Study Arms (1)

Epigenetics characterization

EXPERIMENTAL
Procedure: Endometrial biopsy or menstrual cup and blood sample

Interventions

Endometrial biopsy or menstrual cup and blood samplePROCEDURE

Enrolled patients will give their menstrual effluent either via a menstrual cup or via a pipelle biopsy. They will also undergo a blood draw.

Epigenetics characterization

Eligibility Criteria

Age18 Years - 56 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal
  • In spontaneous menstrual cycle (no hormonal treatments for the last 3 months)
  • Healthy or with a clear diagnosis of endometriosis via ultrasound, MRI or laparoscopy

You may not qualify if:

  • HIV or Hepatitis positive
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Menstrual Hygiene ProductsBlood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Feminine Hygiene ProductsEquipment and SuppliesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Marie-Madeleine Dolmans, MD, PhD

CONTACT

+32 (0)2 764 5287marie-madeleine.dolmans@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

June 3, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)