Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-01-05 @ 12:37 PM
Study NCT ID:
NCT02640261
Status:
UNKNOWN
Last Update Posted:
2016-02-03
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Follicular Fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-12-22', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Delivery Rate', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['r-hLH', 'Cytokines', 'Follicular Fluid'], 'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content.\n\n100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort \\< 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.\n\nPatients will be part of one of the following groups:\n\nGroup 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normogonadotropic Infertile Women that failed the first IVFcycle and require r-hLh add on therapy as per Demetra clinical standard procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women age from \\< 38 years\n* normal body mass index (BMI ) from 18 to 26\n* parameters for ovarian reserve in the normal range (day 3 FSH levels \\< 10 mUI/ml ; day 3 E2 levels \\< 80 pg/ml; anti-mullerian hormone (AMH) levels \\> 1.5 ng/ml ; AFC (antral follicular count) \\> 6 )\n\nExclusion Criteria:\n\n* polycystic ovary syndrome (PCOS)\n* ovarian surgery\n* pelvic endometriosis\n* POR according to ESHRE criteria'}, 'identificationModule': {'nctId': 'NCT02640261', 'briefTitle': 'Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.', 'organization': {'class': 'OTHER', 'fullName': 'Centro di Procreazione Assistita Demetra'}, 'orgStudyIdInfo': {'id': 'Echelo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Single embryo transfer on day 5, according to standard embryo morphological criteria'}, {'label': 'Group 2', 'description': 'Single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50129', 'city': 'Florence', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristiana Barbosa, MD', 'role': 'CONTACT', 'email': 'quartim.barbosa@centrodemetra.com', 'phone': '00393478838377'}], 'facility': 'DEMETRA', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'centralContacts': [{'name': 'Elisabetta Chelo, MD', 'role': 'CONTACT', 'email': 'elisabetta.chelo@gmail.com', 'phone': '0039 335457607'}, {'name': 'Cristiana Barbosa, MD', 'role': 'CONTACT', 'email': 'quartim.barbosa@centrodemetra.com', 'phone': '003903478838377'}], 'overallOfficials': [{'name': 'Elisabetta Chelo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Center DEMETRA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Procreazione Assistita Demetra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}