Skip to main content
OpenTrials
Completed

NCT Number: NCT05815134

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

Primary outcomes

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

    Time frame: day 1

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

  2. cell free DNA rate in follicular fluid the day of punction

    Time frame: day 1

    cell free DNA in follicular fluid the day of punction

Secondary outcomes

  1. number of oocytes reaching the metaphase II

    Time frame: 1 year

    number of oocytes reaching the metaphase II in both groups of patients

  2. fragmentation rate

    Time frame: 1 year

    fragmentation rate

  3. number of cells at day 2

    Time frame: day 2

    number of cells at day 2

  4. number of cells at day 3

    Time frame: day 3

    number of cells at day 3

  5. blastulation rate at day 5 of developement

    Time frame: day 5

    blastulation rate at day 5 of developement

  6. number of clinical pregnancy in both groups

    Time frame: 1 year

  7. number of live birth in both groups

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ENDO-FIV

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.