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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05815134
Acronym
ENDO-FIV
Enrollment
114
Registered
2023-04-18
Start date
2020-08-26
Completion date
2025-07-01
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cell Free DNA, Endometriosis

Keywords

Endometriosis, cell free DNA, oocyte quality

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.

Interventions

BIOLOGICALblood sample

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cell free DNA rate in serum in patients before they start IVF stimulationday 1cell 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 punctionday 1cell free DNA in follicular fluid the day of punction

Secondary

MeasureTime frameDescription
number of live birth in both groups1 year
number of oocytes reaching the metaphase II1 yearnumber of oocytes reaching the metaphase II in both groups of patients
blastulation rate at day 5 of developementday 5blastulation rate at day 5 of developement
number of cells at day 2day 2number of cells at day 2
number of cells at day 3day 3number of cells at day 3
fragmentation rate1 yearfragmentation rate
number of clinical pregnancy in both groups1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026