Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00956267
Status:
COMPLETED
Last Update Posted:
2009-08-11
First Post:
2009-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-10', 'studyFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of ovulation and midcycle endometrial thickness (mm).'}], 'secondaryOutcomes': [{'measure': 'occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polycystic ovary syndrome', 'clomiphene resistance', 'letrozole', 'Laparoscopic ovarian diathermy'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '16595197', 'type': 'BACKGROUND', 'citation': 'Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.'}, {'pmid': '14739186', 'type': 'BACKGROUND', 'citation': 'Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192. doi: 10.1136/bmj.328.7433.192.'}, {'pmid': '17636653', 'type': 'BACKGROUND', 'citation': "Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.', 'detailedDescription': 'In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CC resistant PCOS\n\nExclusion Criteria:\n\n* Congenital adrenal hyperplasia\n* Cushing syndrome\n* Androgen secreting tumors'}, 'identificationModule': {'nctId': 'NCT00956267', 'briefTitle': 'Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'MU- 094'}, 'secondaryIdInfos': [{'id': 'FMH-052-K'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole', 'description': '2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles', 'interventionNames': ['Drug: Letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic ovarian diathermy (LOD)', 'description': 'Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.', 'interventionNames': ['Procedure: Laparoscopic ovarian diathermy (LOD)']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'description': '2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles', 'armGroupLabels': ['Letrozole']}, {'name': 'Laparoscopic ovarian diathermy (LOD)', 'type': 'PROCEDURE', 'description': 'Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.', 'armGroupLabels': ['Laparoscopic ovarian diathermy (LOD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals,OB/GYN department', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Hatem Abu Hashim, MD. MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University Hospital'}, {'name': 'Abdel Maged Mashaly, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University Hospital'}, {'name': 'Ahmed Badawy, MD.PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN', 'oldOrganization': 'Mansoura Faculty of Medicine, Mansoura University.'}}}}