Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-26 @ 1:41 AM
Study NCT ID:
NCT06304220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two PPOS Models for Pituitary Suppression
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D009644', 'term': 'Norgestrel'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of oocytes retrieved from follicular puncture', 'timeFrame': '5 months', 'description': 'The total number of oocytes retrieved from the follicular puncture shall be counted.'}, {'measure': 'Number of mature oocytes (MII) retrieved from follicular puncture', 'timeFrame': '5 months', 'description': 'The number of mature oocytes (MII) recovered from the follicular puncture shall be counted.'}], 'secondaryOutcomes': [{'measure': 'Oocyte quality variables', 'timeFrame': '5 months', 'description': 'Oocyte morphology will be assessed following the standard grading system established in Next Fertility, according to the criteria mentioned above.'}, {'measure': 'Ovarian sensitivity index (OSI', 'timeFrame': '5 months', 'description': 'total dose of gonadotrophin used/total number of MII oocytes obtained) x 1000'}, {'measure': 'Follicles', 'timeFrame': '5 months', 'description': 'Number of basal antral follicles of each size at the time of starting COH, Total number of follicles on the day of the second control and Number of follicles at the time of administering the trigger.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primed-progestin ovarian stimulation protocol', 'Quality of oocytes', 'Oocyte yield', 'Ovarian Sensitivty Index', 'Controlled ovarian hyperstimulation'], 'conditions': ['Infertility, Female', 'Fertility Disorders']}, 'referencesModule': {'references': [{'pmid': '31138494', 'type': 'BACKGROUND', 'citation': 'La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29.'}, {'pmid': '28062551', 'type': 'BACKGROUND', 'citation': 'Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.'}, {'pmid': '31081407', 'type': 'BACKGROUND', 'citation': 'Martinez F, Rodriguez-Purata J, Clua E, Garcia S, Coroleu B, Polyzos N. Ovarian response in oocyte donation cycles under LH suppression with GnRH antagonist or desogestrel progestin: retrospective and comparative study. Gynecol Endocrinol. 2019 Oct;35(10):884-889. doi: 10.1080/09513590.2019.1604662. Epub 2019 May 12.'}, {'pmid': '31062995', 'type': 'BACKGROUND', 'citation': 'Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7.'}, {'pmid': '30927417', 'type': 'BACKGROUND', 'citation': 'Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.'}, {'pmid': '3427965', 'type': 'BACKGROUND', 'citation': 'Phillips A, Hahn DW, Klimek S, McGuire JL. A comparison of the potencies and activities of progestogens used in contraceptives. Contraception. 1987 Aug;36(2):181-92. doi: 10.1016/0010-7824(87)90013-8.'}, {'pmid': '11473970', 'type': 'BACKGROUND', 'citation': 'Mikkelsen AL, Lindenberg S. Morphology of in-vitro matured oocytes: impact on fertility potential and embryo quality. Hum Reprod. 2001 Aug;16(8):1714-8. doi: 10.1093/humrep/16.8.1714.'}, {'pmid': '18249393', 'type': 'BACKGROUND', 'citation': 'Rienzi L, Ubaldi FM, Iacobelli M, Minasi MG, Romano S, Ferrero S, Sapienza F, Baroni E, Litwicka K, Greco E. Significance of metaphase II human oocyte morphology on ICSI outcome. Fertil Steril. 2008 Nov;90(5):1692-700. doi: 10.1016/j.fertnstert.2007.09.024. Epub 2008 Feb 4.'}, {'pmid': '26568757', 'type': 'BACKGROUND', 'citation': 'Kazemi A, Ramezanzadeh F, Nasr-Esfahani MH. The relations between dietary antioxidant vitamins intake and oxidative stress in follicular fluid and ART outcomes. Iran J Reprod Med. 2015 Sep;13(9):533-40.'}, {'pmid': '25198264', 'type': 'BACKGROUND', 'citation': 'Gaskins AJ, Afeiche MC, Wright DL, Toth TL, Williams PL, Gillman MW, Hauser R, Chavarro JE. Dietary folate and reproductive success among women undergoing assisted reproduction. Obstet Gynecol. 2014 Oct;124(4):801-809. doi: 10.1097/AOG.0000000000000477.'}]}, 'descriptionModule': {'briefSummary': "The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.", 'detailedDescription': 'This is a multicenter, randomized, controlled clinical study comparing two different progestogens for pituitary suppression in normo-responding patients undergoing controlled ovarian hyperstimulation (COH) for egg donation. Patients will be recruited on the day they begin the egg donation program. Before inclusion, patients must meet all inclusion and exclusion criteria and provide written informed consent. Each patient will be assigned a patient code based on the treatment group they are included in. Treatment with the assigned progestogens will start on the first day of COH. The standard protocol for egg donation will be followed, including stimulation with FSHr (Puregon®), pituitary suppression with either Medroxyprogesterone acetate (Progevera®) or Desogestrel (Cerazet®), and trigger with GnRH agonist (Triptorelin acetate, Decapeptyl®) 36 hours before oocyte retrieval. Patients will continue taking the assigned progestogen throughout the COH period. Oocyte quality will be assessed based on maturity and morphology, with mature oocytes classified as normal or good quality and abnormal oocytes categorized into intracytoplasmic and extracytoplasmic abnormalities. Quality assessment will be performed by two blinded embryologists.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 18-29,9 kg/m2\n* Ultrasound count of antral follicles prior to COH ≥ 12 follicles\n* Meeting the criteria for inclusion in the egg donation program\n* Normal karyotype and no active sexually transmitted diseases\n* No use of combined hormonal contraceptives one month before COH\n\nExclusion Criteria:\n\n* Patients excluded from the egg donation program\n* Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV\n* Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis.\n* Oligomenorrhea (\\<1 menstrual cycle in 3 months)\n* Use of combined hormonal contraceptives before COH'}, 'identificationModule': {'nctId': 'NCT06304220', 'briefTitle': 'Comparison of Two PPOS Models for Pituitary Suppression', 'organization': {'class': 'INDUSTRY', 'fullName': 'NextFertility'}, 'officialTitle': 'Comparación de Dos Modelos de PPOS Para supresión Hipofisaria en Ciclos de estimulación ovárica, Desogestrel vs Medroxiprogesterona', 'orgStudyIdInfo': {'id': 'MedroGestrel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group DSG: Desogestrel', 'description': 'Desogestrel Cerazet® 75 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).', 'interventionNames': ['Drug: Cerazet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group MPA: Medroxyprogesterone', 'description': 'Medroxyprogesterone acetate Progevera® 10 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).', 'interventionNames': ['Drug: Cerazet']}], 'interventions': [{'name': 'Cerazet', 'type': 'DRUG', 'otherNames': ['Progevera'], 'description': 'Comparation of the utilization of two distinct progestogens for pituitary suppression', 'armGroupLabels': ['Group DSG: Desogestrel', 'Group MPA: Medroxyprogesterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'contacts': [{'name': 'Luis Quintero', 'role': 'CONTACT', 'email': 'luis.quintero@next-clinics.com', 'phone': '+34 963160240'}], 'facility': 'NextFertility', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Luis Quintero', 'role': 'CONTACT', 'email': 'luis.quintero@next-clinics.com', 'phone': '+34 963160240'}], 'overallOfficials': [{'name': 'Luis Quintero', 'role': 'STUDY_CHAIR', 'affiliation': 'NextFertility'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NextFertility', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SINAE SL', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}