Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-03-03 @ 1:30 PM
Study NCT ID:
NCT02940535
Status:
UNKNOWN
Last Update Posted:
2016-10-21
First Post:
2016-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response
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': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D008596', 'term': 'Menotropins'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], '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'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'multiple pregnancy', 'timeFrame': '3 years', 'description': 'The condition of carrying two or more FETUSES.'}, {'measure': 'miscarriage', 'timeFrame': '3 years', 'description': 'Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.'}, {'measure': 'Ectopic pregnancy', 'timeFrame': '3 years', 'description': 'A potentially life-threatening condition in which EMBRYO IMPLANTATION occurs outside the cavity of the UTERUS. Most ectopic pregnancies (\\>96%) occur in the FALLOPIAN TUBES, known as TUBAL PREGNANCY. They can be in other locations, such as UTERINE CERVIX; OVARY; and abdominal cavity (PREGNANCY, ABDOMINAL).'}, {'measure': 'Dose of HMG required', 'timeFrame': '3 years'}, {'measure': 'Duration of HMG stimulation', 'timeFrame': '3 years'}, {'measure': 'Number of oocytes retrieved', 'timeFrame': '3 years'}, {'measure': 'Number of embryos obtained', 'timeFrame': '3 years'}, {'measure': 'Number of embryos frozen', 'timeFrame': '3 years'}, {'measure': 'Adverse effects', 'timeFrame': '3 years', 'description': 'According to the Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 2009). Some adverse events will be studied as separate outcomes, including ovarian hyperstimulation syndrome (OHSS).'}, {'measure': 'Congenital Abnormalities', 'timeFrame': '3 years', 'description': 'Malformations of organs or body parts during development in utero.'}], 'primaryOutcomes': [{'measure': 'live birth', 'timeFrame': '3 years', 'description': 'The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '3 years', 'description': 'Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Subfertility, Female', 'Ovulation Disorder']}, 'referencesModule': {'references': [{'pmid': '39783453', 'type': 'DERIVED', 'citation': 'Siristatidis CS, Yong LN, Maheshwari A, Ray Chaudhuri Bhatta S. Gonadotropin-releasing hormone agonist protocols for pituitary suppression in assisted reproduction. Cochrane Database Syst Rev. 2025 Jan 9;1(1):CD006919. doi: 10.1002/14651858.CD006919.pub5.'}]}, 'descriptionModule': {'briefSummary': 'The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \\<7 follicles or AMH \\<1.1 ng/ml).\n\nExclusion Criteria:\n\n* Contraindications for IVF/ICSI\n* Contraindications for pregnancy\n* Primary ovarian insufficiency\n* AFC \\<3\n* PGD/PGS'}, 'identificationModule': {'nctId': 'NCT02940535', 'briefTitle': 'Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'SW001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose GnRHa', 'description': 'Diphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28.', 'interventionNames': ['Drug: Diphereline (Triptorelin embonate)', 'Drug: human menopausal gonadotropin', 'Drug: human chorionic gonadotropin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GnRHa Ultra-short Protocol', 'description': 'Decapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2.', 'interventionNames': ['Drug: Decapeptyl (Triptorelin)', 'Drug: human menopausal gonadotropin', 'Drug: human chorionic gonadotropin']}], 'interventions': [{'name': 'Diphereline (Triptorelin embonate)', 'type': 'DRUG', 'armGroupLabels': ['Low Dose GnRHa']}, {'name': 'Decapeptyl (Triptorelin)', 'type': 'DRUG', 'armGroupLabels': ['GnRHa Ultra-short Protocol']}, {'name': 'human menopausal gonadotropin', 'type': 'DRUG', 'armGroupLabels': ['GnRHa Ultra-short Protocol', 'Low Dose GnRHa']}, {'name': 'human chorionic gonadotropin', 'type': 'DRUG', 'armGroupLabels': ['GnRHa Ultra-short Protocol', 'Low Dose GnRHa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100048', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yunhai Chuai, Dr', 'role': 'CONTACT', 'email': 'wangyh85@foxmail.com', 'phone': '+86-18810892004'}], 'facility': 'Navy General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wei Shang, Dr', 'role': 'CONTACT', 'email': 'shang.wei@163.com'}], 'overallOfficials': [{'name': 'Wei Shang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}, {'name': 'Yunhai Chuai, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}, {'name': 'Mingming Shu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}, {'name': 'Ming Zhou, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}, {'name': 'Huiming Han, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}, {'name': 'Mengnan Chen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}, {'name': 'Lei Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Obstetrics and Gynecology, Navy General Hospital, Beijing', 'investigatorFullName': 'Yunhai Chuai', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}