Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-02 @ 8:45 AM
Study NCT ID:
NCT03664050
Status:
UNKNOWN
Last Update Posted:
2018-09-10
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OVULATION RATE', 'timeFrame': '7 DAYS BEFORE NEXT MENSES', 'description': 'SERUM PROGESTERON LEVEL'}], 'secondaryOutcomes': [{'measure': 'BIOCHEMICAL PREGNANCY RATE', 'timeFrame': 'AFTER 30 DAYS OF INTERVENTION', 'description': 'BY SERUM HCG'}, {'measure': 'CLINICAL PREGNANCY RATE', 'timeFrame': 'AT 6 WEEKS GESTATION', 'description': 'BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['letrozol', 'laparoscopic ovarian drilling'], 'conditions': ['Induction of Ovulation']}, 'referencesModule': {'references': [{'pmid': '36165742', 'type': 'DERIVED', 'citation': 'Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patients diagnosed as PCOS according to Roterdam (2003) criteria\n2. patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.\n3. patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.\n4. normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.\n5. normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.\n6. no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.\n\nExclusion Criteria:\n\n1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- \\>40 years old. 4- body mass index (BMI) \\>26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03664050', 'briefTitle': 'Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A Letrozole group', 'description': '2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days.', 'interventionNames': ['Drug: group A 2.5 mg letrozole oral tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B laparoscopic ovarian drilling group', 'description': 'bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.', 'interventionNames': ['Procedure: laparoscopic ovarian drilling']}], 'interventions': [{'name': 'group A 2.5 mg letrozole oral tablets', 'type': 'DRUG', 'description': '2.5 mg letrozole oral tablets will be administered on the 2nd-3rd day of menses and then every day for 5 days. Treatment will be repeated for up to three cycles if the patient failed to conceive.', 'armGroupLabels': ['Group A Letrozole group']}, {'name': 'laparoscopic ovarian drilling', 'type': 'PROCEDURE', 'description': 'Bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.', 'armGroupLabels': ['Group B laparoscopic ovarian drilling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25187', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Elshahawy, MD', 'role': 'CONTACT', 'email': 'ahmedshafy@hotmail.com', 'phone': '+201223266380'}], 'facility': 'Ain shams university maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Abdelshafy, MD', 'role': 'CONTACT', 'email': 'ahmedshafy@hotmail.com', 'phone': '00201223266380'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahmed Abdel Shafy El Shahawy', 'investigatorAffiliation': 'Ain Shams University'}}}}