Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT02477566
Status:
UNKNOWN
Last Update Posted:
2015-06-23
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '2 years', 'description': 'compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment'}], 'secondaryOutcomes': [{'measure': 'moderate/severe OHSS rate', 'timeFrame': '2 years', 'description': 'compare the moderate/severe OHSS rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment'}]}, 'conditionsModule': {'keywords': ['pcos', 'Long acting Triptorelin', 'Short acting Triptorelin', 'In Vitro Fertilization'], 'conditions': ['In Vitro Fertilization', 'Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection', 'detailedDescription': "All patients received standard ovarian stimulation with rFSH under pituitary suppression with GnRH agonist according to a protocol used routinely. The long-acting Triptorelin group use long-acting Triptorelin 1.875mg during the luteal phase on Pituitary down-regulation , the Short acting Triptorelin use short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\\<40pg/ml in serum, was initiated during the luteal phase. Gonadotrophin stimulation of the ovaries was started when serum E2 concentrations declined to \\< 40 pg/ml and a vaginal ultrasonographic scan showed an absence of follicles \\> 10mm diameter. Ovarian stimulation was started wih 150-250 IU/day of recombinant FSH (Gonal F, Serono, Switzerland); the initial dose was determined by clinical judgement of the clinician according to the patients's age, body mass index, basal FSH and E2. Transvaginal ultrasound and E2 measurement were used to monitor follicular growth, and gonadotropin dosages were adjusted accordingly. Ovulation was triggered by intramuscular administration of 5000-10,000 IU of human chorionic gonadotropin (HCG, Ferring Pharmaceuticals) when at least two follicles reached a diameter of 18 mm. Serum HCG value were measured at 12 h after HCG trigger using the immunoassay. Oocytes were retrieved 36 h after the injection of HCG."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS patients diagnosis by Rotterdam Consensus on Diagnostic Criteria who underwent IVF/ICSI treatment\n\nExclusion Criteria:\n\n* Patients with poor ovarian reserve,\n* immunological disease,\n* endometriosis,\n* uterine abnormality,\n* endometrium thickness \\< 8mm before embryo transfer,\n* fewer than two good-quality embryos available for transfer or patients with inadequate data for analysis were excluded.'}, 'identificationModule': {'nctId': 'NCT02477566', 'briefTitle': 'Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University'}, 'officialTitle': 'Comparative Study of Long-acting and Short Acting Triptorelin on Pituitary Down-regulation in Long Protocol in PCOS Patients Who Underwent IVF/ICSI Treatment', 'orgStudyIdInfo': {'id': 'BL2014003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-acting Triptorelin', 'description': 'Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal', 'interventionNames': ['Drug: Long-acting Triptorelin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short-acting Triptorelin', 'description': 'Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\\<40pg/ml in serum, was initiated during the luteal phase', 'interventionNames': ['Drug: Short-acting Triptorelin']}], 'interventions': [{'name': 'Long-acting Triptorelin', 'type': 'DRUG', 'otherNames': ['Long-acting Triptorelin on pituitary down-regulation'], 'description': 'Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase', 'armGroupLabels': ['Long-acting Triptorelin']}, {'name': 'Short-acting Triptorelin', 'type': 'DRUG', 'otherNames': ['Short-acting Triptorelin on pituitary down-regulation'], 'description': 'Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\\<40pg/ml in serum, was initiated during the luteal phase', 'armGroupLabels': ['Short-acting Triptorelin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianjun Zhou, Dcotor', 'role': 'CONTACT', 'email': 'zhou6jj@hotmail.com', 'phone': '86-25-83304616-70014'}], 'facility': 'Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jianjun Zhou, Doctor', 'role': 'CONTACT', 'email': 'zhou6jj@hotmail.com', 'phone': '86-25-83304616-70014'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College', 'investigatorFullName': 'Li-jun Ding', 'investigatorAffiliation': 'Nanjing University'}}}}