NCT05815134

Brief Summary

Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

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

August 26, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

March 20, 2023

Last Update Submit

November 20, 2025

Conditions

EndometriosisCell Free DNA

Keywords

Endometriosiscell free DNAoocyte quality

Outcome Measures

Primary Outcomes (2)

  • cell free DNA rate in serum in patients before they start IVF stimulation

    cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation

    day 1

  • cell free DNA rate in follicular fluid the day of punction

    cell free DNA in follicular fluid the day of punction

    day 1

Secondary Outcomes (7)

  • number of oocytes reaching the metaphase II

    1 year

  • fragmentation rate

    1 year

  • number of cells at day 2

    day 2

  • number of cells at day 3

    day 3

  • blastulation rate at day 5 of developement

    day 5

  • +2 more secondary outcomes

Study Arms (2)

patients with endometriosis

EXPERIMENTAL
Biological: blood sample

others infertility causes

ACTIVE COMPARATOR
Biological: blood sample

Interventions

blood sampleBIOLOGICAL

10ml of blood will be sampled from patients before undergoing IVF treatment, the cell free DNA will be extracted and then quantified by a real time PCR. Another 10ml sample will be drawn the day of oocyte puncture for a new quantification of cell free DNA in plasma and cell free DNA will also be dose in follicular fluid of patients

others infertility causespatients with endometriosis

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients eligible medical assistance to procreation who are about to undergo IVF treatment
  • aged between 18 and 43 years old
  • and who have signed a consent form

You may not qualify if:

  • patients who are not eligible for medical assistance to procreation,
  • patients who are followed for other inflammatory disease,
  • patients followed for premature ovarian failure or
  • patients with a recent story of pelvic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

Location

Related Publications (1)

  • https://dumas.ccsd.cnrs.fr/dumas-03767871v1/file/2022AMIEM032_VANDECANDELAERE_Albane.pdf

    RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 18, 2023

Study Start

August 26, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)