Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation

Not Applicable

Active, not recruiting

• Conditions: Cell Free DNA; Endometriosis
• Interventions: Biological: blood sample

• Registration Number: NCT05815134
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Primary Completion: 2023-07-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-04
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with endometriosis	blood sample	-
others infertility causes	blood sample	-

Primary Outcome Measures

Name	Time	Method
cell free DNA rate in serum in patients before they start IVF stimulation	day 1	cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation
cell free DNA rate in follicular fluid the day of punction	day 1	cell free DNA in follicular fluid the day of punction

Secondary Outcome Measures

Name	Time	Method
number of cells at day 3	day 3	number of cells at day 3
number of live birth in both groups	1 year
blastulation rate at day 5 of developement	day 5	blastulation rate at day 5 of developement
number of cells at day 2	day 2	number of cells at day 2
number of oocytes reaching the metaphase II	1 year	number of oocytes reaching the metaphase II in both groups of patients
fragmentation rate	1 year	fragmentation rate
number of clinical pregnancy in both groups	1 year

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France