Back to resultsCell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation (ENDO-FIV)
Primary Purpose
Endometriosis, Cell Free DNA
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Endometriosis focused on measuring Endometriosis, cell free DNA, oocyte quality
Eligibility Criteria
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
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patients with endometriosis
others infertility causes
Arm Description
Outcomes
Primary Outcome Measures
cell free DNA rate in serum in patients before they start IVF stimulation
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
cell free DNA in follicular fluid the day of punction
Secondary Outcome Measures
number of oocytes reaching the metaphase II
number of oocytes reaching the metaphase II in both groups of patients
fragmentation rate
fragmentation rate
number of cells at day 2
number of cells at day 2
number of cells at day 3
number of cells at day 3
blastulation rate at day 5 of developement
blastulation rate at day 5 of developement
number of clinical pregnancy in both groups
number of live birth in both groups
Full Information
NCT ID
NCT05815134
First Posted
March 20, 2023
Last Updated
April 3, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05815134
Brief Title
Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
Acronym
ENDO-FIV
Official Title
Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Cell Free DNA
Keywords
Endometriosis, cell free DNA, oocyte quality
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with endometriosis
Arm Type
Experimental
Arm Title
others infertility causes
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
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 Outcome Measure Information:
Title
cell free DNA rate in serum in patients before they start IVF stimulation
Description
cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation
Time Frame
day 1
Title
cell free DNA rate in follicular fluid the day of punction
Description
cell free DNA in follicular fluid the day of punction
Time Frame
day 1
Secondary Outcome Measure Information:
Title
number of oocytes reaching the metaphase II
Description
number of oocytes reaching the metaphase II in both groups of patients
Time Frame
1 year
Title
fragmentation rate
Description
fragmentation rate
Time Frame
1 year
Title
number of cells at day 2
Description
number of cells at day 2
Time Frame
day 2
Title
number of cells at day 3
Description
number of cells at day 3
Time Frame
day 3
Title
blastulation rate at day 5 of developement
Description
blastulation rate at day 5 of developement
Time Frame
day 5
Title
number of clinical pregnancy in both groups
Time Frame
1 year
Title
number of live birth in both groups
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalie Cabry, Pr
Phone
0322087368
Email
Cabry.Rosalie@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalie Cabry, Pr
Email
Cabry.Rosalie@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
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