Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-03-14 @ 5:35 PM
Study NCT ID:
NCT03354494
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2017-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017135', 'term': 'Desogestrel'}, {'id': 'C437186', 'term': 'follicle stimulating hormone, human, with HCG C-terminal peptide'}], 'ancestors': [{'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-24', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-11-24', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total dose of gonadotrophins', 'timeFrame': 'At the end of stimulation treatment period (from day of corifollitropin administration until the day of triggering) ) an average 10 days after beginning treatment', 'description': 'Sum of gonadotrophins dose'}, {'measure': 'Oocyte retrieved', 'timeFrame': 'Oocyte retrieval day an average 10 days after beginning treatment', 'description': 'Number of oocyte retrieved'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oocyte donors', 'Ovarian stimulation', 'Desogestrel', 'Corifolitropina alfa', 'Gonadotropins'], 'conditions': ['Controlled Ovaria Stimulation']}, 'referencesModule': {'references': [{'pmid': '16632462', 'type': 'BACKGROUND', 'citation': 'Martinez F, Boada M, Coroleu B, Clua E, Parera N, Rodriguez I, Barri PN. A prospective trial comparing oocyte donor ovarian response and recipient pregnancy rates between suppression with gonadotrophin-releasing hormone agonist (GnRHa) alone and dual suppression with a contraceptive vaginal ring and GnRH. Hum Reprod. 2006 Aug;21(8):2121-5. doi: 10.1093/humrep/del121. Epub 2006 Apr 21.'}, {'pmid': '20430379', 'type': 'BACKGROUND', 'citation': 'Martinez F, Clua E, Santmarti P, Boada M, Rodriguez I, Coroleu B. Randomized, comparative pilot study of pituitary suppression with depot leuprorelin versus cetrorelix acetate 3 mg in gonadotropin stimulation protocols for oocyte donors. Fertil Steril. 2010 Nov;94(6):2433-6. doi: 10.1016/j.fertnstert.2010.02.059. Epub 2010 Apr 28.'}, {'pmid': '23352098', 'type': 'BACKGROUND', 'citation': 'Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Munoz M, Garcia-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin alpha. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5.'}], 'seeAlsoLinks': [{'url': 'http://www.dexeus.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge.\n\nIn donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response.\n\nOther authors have reported good results using similar synthetic progestins (Medroxyprogesterone, dihydrogesterone, and natural progesterone).\n\nNo description of the hormonal and ovarian response under this protocol has been published. Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily gonadotropins has not been reported.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- Population: donors (18-35 ) from candidates of Donor program', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Fulfilling inclusión medical and legal criteria (RD - Spanish law adapting european rule-9/2014)\n\n* Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections\n* Given signed consent form.\n\nExclusion Criteria:\n\n* Previous low response to COS\n* Previous ovarian hyperstimulation syndrome.\n* Ovarian cysts.'}, 'identificationModule': {'nctId': 'NCT03354494', 'briefTitle': 'Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Dexeus'}, 'officialTitle': 'Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors', 'orgStudyIdInfo': {'id': 'SMD-DSG-2017-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DSG-CTP', 'interventionNames': ['Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa']}], 'interventions': [{'name': 'Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa', 'type': 'DRUG', 'armGroupLabels': ['DSG-CTP']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Dexeus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Dr. Francisca Martínez', 'investigatorAffiliation': 'Fundacion Dexeus'}}}}