Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 5:59 PM
Study NCT ID:
NCT03307720
Status:
UNKNOWN
Last Update Posted:
2017-12-11
First Post:
2017-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'IVF patients enrolled either to HCG or agonist trigger ovulation induction'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2017-09-30', 'studyFirstSubmitQcDate': '2017-10-06', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mature oocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'Number of mature oocytes achieved after oocyte retrieval.'}], 'secondaryOutcomes': [{'measure': 'Relation mature oocytes/punctured oocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'Relation between the number of mature oocytes and the follicles.'}, {'measure': 'Fertilized oocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'Number of fertilized oocytes'}, {'measure': 'Relation fertilized oocytes/achieved Mature oocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'Relation between the number of fertilized oocytes and the mature oocytes achieved.'}, {'measure': 'Number of blastocysts developed', 'timeFrame': 'Up to 24 weeks', 'description': 'Number of blastocysts developed in each arm of the study.'}, {'measure': 'Cancelled cycles', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of cancelled cycles'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['agonist trigger', 'Ovulation induction', 'Controlled ovarian stimulation (COS)', 'Poor responder'], 'conditions': ['Ovulation Induction', 'In Vitro Fertilization (IVF)', 'Infertility, Female', 'Oocytes']}, 'descriptionModule': {'briefSummary': 'Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS).\n\nIndeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients:\n\n1. Poor responders.\n2. Normo-responders\n3. High responders Comparing both the number and the quality of achieved oocytes.', 'detailedDescription': 'During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.\n\nOn the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. Defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval.\n\nDifferent strategies have been proposed to overcome this problem. In other words, to obtain more oocytes. These include an increase in FSH doses, an increase in FSH action by adding sensitizers agents.\n\nAmong the possible strategies, investigators propose the agonist triggering. HCG (classical) triggering represents the use of a LH-like product (with a prolonged action). The administration of a GnRH agonist provoke the production and liberation of both FSH and LH. Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.\n\nSo, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the OHSS risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women scheduled for IVF treatment.\n* First ovarian stimulation\n* Two ovaries present\n* No previous ovarian surgery\n* No contraindication for any of the assigned treatments\n\nExclusion Criteria:\n\n* Previous ovarian surgery.\n* Previous IVF treatments.\n* Absence of one ovary\n* Presence of an endometrioma'}, 'identificationModule': {'nctId': 'NCT03307720', 'briefTitle': 'Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)', 'organization': {'class': 'OTHER', 'fullName': 'Ginegorama S.L.'}, 'officialTitle': 'Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)', 'orgStudyIdInfo': {'id': 'AGONIST TRIGGER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Poor responders. Classical trigger', 'description': 'Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.\n\nWomen scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.', 'interventionNames': ['Drug: Human chorionic gonadotropin']}, {'type': 'EXPERIMENTAL', 'label': 'Poor responders. Agonist trigger', 'description': 'Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)\n\nWomen scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.', 'interventionNames': ['Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normo responders. Classical trigger', 'description': 'Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.\n\nWomen scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.', 'interventionNames': ['Drug: Human chorionic gonadotropin']}, {'type': 'EXPERIMENTAL', 'label': 'Normo responders. Agonist trigger', 'description': 'Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)\n\nWomen scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.', 'interventionNames': ['Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High responders. Classical trigger', 'description': 'Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.\n\nWomen scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.', 'interventionNames': ['Drug: Human chorionic gonadotropin']}, {'type': 'EXPERIMENTAL', 'label': 'High responders. Agonist trigger', 'description': 'Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)\n\nWomen scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.', 'interventionNames': ['Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)']}], 'interventions': [{'name': 'Gonadotropin Releasing Hormone Agonists (GNRH-A)', 'type': 'DRUG', 'otherNames': ['Agonist trigger'], 'description': 'Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.', 'armGroupLabels': ['High responders. Agonist trigger', 'Normo responders. Agonist trigger', 'Poor responders. Agonist trigger']}, {'name': 'Human chorionic gonadotropin', 'type': 'DRUG', 'otherNames': ['HCG trigger'], 'description': 'Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.', 'armGroupLabels': ['High responders. Classical trigger', 'Normo responders. Classical trigger', 'Poor responders. Classical trigger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48014', 'city': 'Bilbao', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'Reproduccion Bilbao Assisted Reproduction Center', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}], 'centralContacts': [{'name': 'Gorka Barrenetxea, PhD', 'role': 'CONTACT', 'email': 'gbarrenetxea@reproduccionbilbao.es', 'phone': '00 34 605711484'}, {'name': 'Amaia Garcia, PhD', 'role': 'CONTACT', 'email': 'agarcia@reproduccionbilbao.es'}], 'overallOfficials': [{'name': 'Gorka Barrenetxea, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea'}, {'name': 'Jon Iker Arambarri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ginegorama S.L.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao', 'investigatorFullName': 'Gorka Barrenetxea', 'investigatorAffiliation': 'Ginegorama S.L.'}}}}