Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation (ENDO-FIV)

April 3, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with endometriosis
Biological: blood 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
Active Comparator: others infertility causes
Biological: blood 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1
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
day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2019_843_0087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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