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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05815134

Collaborator

(none)

114

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Cell Free DNA	Biological: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 cells at day 2 [day 2]
number of cells at day 2
number of cells at day 3 [day 3]
number of cells at day 3
blastulation rate at day 5 of developement [day 5]
blastulation rate at day 5 of developement
number of clinical pregnancy in both groups [1 year]
number of live birth in both groups [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens		France

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05815134

Other Study ID Numbers:

PI2019_843_0087

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Endometriosis

cell free DNA

oocyte quality

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Apr 18, 2023