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

Endometriosis Clinical Trial

— ENDO-FIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815134
• Other study ID #: PI2019_843_0087
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 1
Primary	cell free DNA rate in follicular fluid the day of punction	cell free DNA in follicular fluid the day of punction	day 1
Secondary	number of oocytes reaching the metaphase II	number of oocytes reaching the metaphase II in both groups of patients	1 year
Secondary	fragmentation rate	fragmentation rate	1 year
Secondary	number of cells at day 2	number of cells at day 2	day 2
Secondary	number of cells at day 3	number of cells at day 3	day 3
Secondary	blastulation rate at day 5 of developement	blastulation rate at day 5 of developement	day 5
Secondary	number of clinical pregnancy in both groups		1 year
Secondary	number of live birth in both groups		1 year