Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2026-02-26 @ 12:06 PM
Study NCT ID:
NCT03006406
Status:
UNKNOWN
Last Update Posted:
2016-12-30
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-29', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '5 weeks after embryo transfer'}], 'secondaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': '1 day at oocyte retrieved day'}, {'measure': '2 pronucleus(2PN)fertilization rate', 'timeFrame': '48hours after oocyte retrieved day', 'description': 'Number of 2PN/Matured oocytes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endometriosis', 'long term GnRH-a'], 'conditions': ['Clinical Pregnancy Rate']}, 'referencesModule': {'references': [{'pmid': '24262434', 'type': 'BACKGROUND', 'citation': 'van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. Epub 2013 Oct 9.'}, {'pmid': '20409633', 'type': 'BACKGROUND', 'citation': 'Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. Epub 2010 Apr 21.'}, {'pmid': '30572916', 'type': 'DERIVED', 'citation': 'Kong H, Hu L, Nie L, Yu X, Dai W, Li J, Chen C, Bu Z, Shi H, Wu Q, Guan Y, Sun Y. A multi-center, randomized controlled clinical trial of the application of a shortened protocol of long-acting Triptorelin down-regulated prior to IVF/ICSI among patients with endometriosis: A protocol. Reprod Health. 2018 Dec 20;15(1):213. doi: 10.1186/s12978-018-0639-8.'}]}, 'descriptionModule': {'briefSummary': 'Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first IVF cycle;\n* with normal ovarian reserve(FSH(10miu/ml； antral follicle count )3)\n* with normal uterine\n\nExclusion Criteria:\n\n* Pre-implantation genetic diagnosis cycles;\n* Oocyte donation cycles'}, 'identificationModule': {'nctId': 'NCT03006406', 'briefTitle': 'Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'orgStudyIdInfo': {'id': 'ENDO-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Long term GnRH-a for 1 month', 'description': 'patient in this group only receive GnRH-a 3.75 for 1 month', 'interventionNames': ['Drug: Long term GnRH-a (3.75mg)']}, {'type': 'EXPERIMENTAL', 'label': 'patient in this group only receive GnRH-a 3.75 for 2 month', 'description': 'patient in this group only receive GnRH-a 3.75 for 2 month', 'interventionNames': ['Drug: Long term GnRH-a (3.75mg)']}], 'interventions': [{'name': 'Long term GnRH-a (3.75mg)', 'type': 'DRUG', 'description': 'patient in this group only receive GnRH-a 3.75 for pituitary down-regulation', 'armGroupLabels': ['Long term GnRH-a for 1 month', 'patient in this group only receive GnRH-a 3.75 for 2 month']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingpu Ms Sun, M.D,PhD', 'role': 'CONTACT', 'email': 'syp2008@vip.sina.com', 'phone': '86-13803841888'}, {'name': 'Zhiqin Mr Bu, MD', 'role': 'CONTACT', 'email': 'rmczzu@126.com', 'phone': '86-15981978863'}], 'facility': 'Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Huijuan Kong, M.D.', 'role': 'CONTACT', 'email': 'luckyjuanjuan819@126.com', 'phone': '86-371-67966161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Reproductive Medical Center,1st Affilated Hospital, Zhengzhou University', 'investigatorFullName': 'Yingpu Sun', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}