Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-29 @ 5:38 PM
Study NCT ID:
NCT01058603
Status:
UNKNOWN
Last Update Posted:
2010-02-04
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infertility', 'Cell Culture', 'AECC', 'Endocell', 'IVF'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged ≥ 18 and ≤ 36\n* Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI)\n* Having experienced no more than 1 Embryo Transfer failure\n* With basal FSH level ≤ 12 IU/l within the 6 months prior to the study\n* Endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation)\n* Negative serology for HIV 1 and 2, hepatitis B and C, HTLV 1 and 2, syphilis\n\nExclusion Criteria:\n\n* Hypersensitivity to one of the culture media components\n* Oocyte donation, sperm donation\n* Thawed embryos transfer\n* Women with endometriosis grade III and IV, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps\n* Women affected by pathologies associated with any contraindication of being pregnant\n* Abnormal gynaecologic bleeding of undetermined origin\n* Uncontrolled thyroid (TSH dosage) or adrenal dysfunction\n* Neoplasias, any pathologies of the endometrium or the cervix'}, 'identificationModule': {'nctId': 'NCT01058603', 'briefTitle': 'Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Genévrier'}, 'officialTitle': 'Multicentre, Randomised, Controlled Clinical Study on the Efficacy in Terms of Clinical Pregnancy Rate of 1 Embryo Transfer at Day 5 After Co-culture on Autologous Endometrial Cells(ENDOCELL®) Versus 1 Embryo Transfer at Day 3 After Culture on Conventional Medium.', 'orgStudyIdInfo': {'id': '07F/END01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'D3', 'interventionNames': ['Other: - Conventional culture medium for IVF']}, {'type': 'EXPERIMENTAL', 'label': 'D5', 'interventionNames': ['Other: - Endocell®']}], 'interventions': [{'name': '- Conventional culture medium for IVF', 'type': 'OTHER', 'description': 'Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen', 'armGroupLabels': ['D3']}, {'name': '- Endocell®', 'type': 'OTHER', 'description': 'Embryos are cultured on ENDOCELL® from Day 2 to Day 5 (Blastocyst stage) One embryo is transferred at Day 5. Supernumerary good quality embryos are frozen.', 'armGroupLabels': ['D5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67303', 'city': 'Schiltigheim', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jeanine Ohl, MD', 'role': 'CONTACT', 'email': 'Jeanin.OHL@sihcus.fr', 'phone': '00 (33)3.88.62.84.34'}], 'facility': 'CMCO', 'geoPoint': {'lat': 48.60749, 'lon': 7.74931}}], 'centralContacts': [{'name': 'Anissa Benoussaidh', 'role': 'CONTACT', 'email': 'abenoussaidh@laboratoires-genevrier.com', 'phone': '+33-492914134'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Genévrier', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldOrganization': 'Laboratoires Genévrier'}}}}