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

NCT ID: NCT05815134

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis Cell Free DNA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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patients with endometriosis

Group Type EXPERIMENTAL

blood sample

Intervention Type 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

others infertility causes

Group Type ACTIVE_COMPARATOR

blood sample

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, , France

Site Status

Countries

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France

References

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https://dumas.ccsd.cnrs.fr/dumas-03767871v1/file/2022AMIEM032_VANDECANDELAERE_Albane.pdf

Reference Type RESULT

Other Identifiers

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PI2019_843_0087

Identifier Type: -

Identifier Source: org_study_id

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