Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02022228
Status:
UNKNOWN
Last Update Posted:
2013-12-27
First Post:
2013-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2013-12-15', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate per transfer cycle', 'timeFrame': '1month post embryo transfer'}, {'measure': 'numbers of patients having OHSS', 'timeFrame': '2 weeks post trigger with dual GnRHa'}, {'measure': 'oocyte yield', 'timeFrame': 'oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)', 'description': 'Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.'}, {'measure': 'Oocyte maturity', 'timeFrame': '24 hours post oocyte retrieval day', 'description': 'Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI).'}], 'secondaryOutcomes': [{'measure': 'serum luteinizing hormone level 12 hours post trigger', 'timeFrame': '12 hours post trigger'}, {'measure': 'serum hCG level 12 hours post trigger', 'timeFrame': '12 hours post trigger'}, {'measure': 'fertilization rate', 'timeFrame': '48 hours post IVF/ICSI', 'description': 'Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization (i.e. the denominator in IVF in calculating fertilization rate is all oocytes recovered, but in ICSI it is calculated using only the number of MII oocytes).'}, {'measure': 'implantation rate', 'timeFrame': '1 month post embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian Hyperstimulation Syndrome', 'Luteinizing Hormone', 'Polycystic Ovarian Syndrome', 'Ovarian Yield', 'Ovarian Maturity', 'Gonadotropin Releasing Hormone Agonist', 'Human Chorionic Gonadotropin'], 'conditions': ['Infertility and at High Risk of OHSS']}, 'descriptionModule': {'briefSummary': 'Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.\n\nHowever, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.\n\nOur aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with polycystic ovarian syndrome\n* patients with polycystic ovarian morphology on ultrasound\n* patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins\n\nExclusion Criteria:\n\n* patients undergoing coasting\n* patients with past ovarian surgery'}, 'identificationModule': {'nctId': 'NCT02022228', 'briefTitle': 'Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol', 'orgStudyIdInfo': {'id': 'Dual Trigger'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.2mg triptorelin and 500 IU hCG', 'description': 'Patients were triggered with 0.2mg triptorelin and 500 IU hCG', 'interventionNames': ['Drug: triptorelin', 'Drug: hCG']}, {'type': 'EXPERIMENTAL', 'label': '0.2mg triptorelin and 1000 IU hCG', 'description': 'Patients were triggered with 0.2mg triptorelin and 1000 IU hCG', 'interventionNames': ['Drug: triptorelin', 'Drug: hCG']}], 'interventions': [{'name': 'triptorelin', 'type': 'DRUG', 'otherNames': ['triptorelin: Diphereline'], 'description': '0.2 mg triptorelin, ih', 'armGroupLabels': ['0.2mg triptorelin and 1000 IU hCG', '0.2mg triptorelin and 500 IU hCG']}, {'name': 'hCG', 'type': 'DRUG', 'description': '1000 IU hCG, im', 'armGroupLabels': ['0.2mg triptorelin and 1000 IU hCG']}, {'name': 'hCG', 'type': 'DRUG', 'description': '500IU hCG, im', 'armGroupLabels': ['0.2mg triptorelin and 500 IU hCG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi-Ling Chen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chensl_92@163.com', 'phone': '+86-20-62787604'}, {'name': 'Shi-Ling Chen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shi-Ling Chen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chensl_92@163.com', 'phone': '+86-20-62787604'}], 'overallOfficials': [{'name': 'Shi-Ling Chen, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chenshiling', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}, {'name': 'Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science', 'class': 'OTHER'}, {'name': 'Guangzhou Science and Technology Program key projects', 'class': 'OTHER'}, {'name': 'National Key Basic Research Development Plan of China', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, M.D., Ph.D.', 'investigatorFullName': 'Chenshiling', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}