Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT05815134
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cell free DNA rate in serum in patients before they start IVF stimulation', 'timeFrame': 'day 1', 'description': 'cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation'}, {'measure': 'cell free DNA rate in follicular fluid the day of punction', 'timeFrame': 'day 1', 'description': 'cell free DNA in follicular fluid the day of punction'}], 'secondaryOutcomes': [{'measure': 'number of oocytes reaching the metaphase II', 'timeFrame': '1 year', 'description': 'number of oocytes reaching the metaphase II in both groups of patients'}, {'measure': 'fragmentation rate', 'timeFrame': '1 year', 'description': 'fragmentation rate'}, {'measure': 'number of cells at day 2', 'timeFrame': 'day 2', 'description': 'number of cells at day 2'}, {'measure': 'number of cells at day 3', 'timeFrame': 'day 3', 'description': 'number of cells at day 3'}, {'measure': 'blastulation rate at day 5 of developement', 'timeFrame': 'day 5', 'description': 'blastulation rate at day 5 of developement'}, {'measure': 'number of clinical pregnancy in both groups', 'timeFrame': '1 year'}, {'measure': 'number of live birth in both groups', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'cell free DNA', 'oocyte quality'], 'conditions': ['Endometriosis', 'Cell Free DNA']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'https://dumas.ccsd.cnrs.fr/dumas-03767871v1/file/2022AMIEM032_VANDECANDELAERE_Albane.pdf'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients eligible medical assistance to procreation who are about to undergo IVF treatment\n* aged between 18 and 43 years old\n* and who have signed a consent form\n\nExclusion Criteria:\n\n* patients who are not eligible for medical assistance to procreation,\n* patients who are followed for other inflammatory disease,\n* patients followed for premature ovarian failure or\n* patients with a recent story of pelvic infection'}, 'identificationModule': {'nctId': 'NCT05815134', 'acronym': 'ENDO-FIV', 'briefTitle': 'Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation', 'orgStudyIdInfo': {'id': 'PI2019_843_0087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with endometriosis', 'interventionNames': ['Biological: blood sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'others infertility causes', 'interventionNames': ['Biological: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', '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', 'armGroupLabels': ['others infertility causes', 'patients with endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}