Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03237312
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2017-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Anti-mullerian Hormone and Polycystic Ovarian 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': 'D054304', 'term': 'Anti-Mullerian Hormone'}], 'ancestors': [{'id': 'D013735', 'term': 'Testicular Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-30', 'studyFirstSubmitDate': '2017-07-30', 'studyFirstSubmitQcDate': '2017-07-30', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of ovarian follicle (mm)', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Antimullerian hormone level (ng/dl)', 'timeFrame': '3 months'}, {'measure': 'Ovarian volume (ml)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Infertility more than 2 years.\n2. Age between 20-35 years.\n3. clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.\n4. No contraindications for laparoscopy.\n5. Normal Hysterosalpingography\n\nExclusion Criteria:\n\n1. Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect….\n2. Women's age less than 20 years or more than 35 years.\n3. Previous Laparoscopic surgery.\n4. Previous ovarian surgery.\n5. Women with Antimullerian hormone level less than 4 ng/ml.\n6. Tubal factor infertility as diagnosed by Hysterosalpingography ."}, 'identificationModule': {'nctId': 'NCT03237312', 'briefTitle': 'Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': 'AMH-PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'The control group', 'description': 'Four punctures in each ovary were done regardless of the level of antimullerian hormone', 'interventionNames': ['Procedure: Laparoscopic ovarian drilling', 'Biological: Antimullerian hormone']}, {'type': 'OTHER', 'label': 'The study group', 'description': 'The number of ovarian drills was adjusted according to antimullerian hormone level', 'interventionNames': ['Procedure: Laparoscopic ovarian drilling', 'Biological: Antimullerian hormone']}], 'interventions': [{'name': 'Laparoscopic ovarian drilling', 'type': 'PROCEDURE', 'description': "The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.", 'armGroupLabels': ['The control group', 'The study group']}, {'name': 'Antimullerian hormone', 'type': 'BIOLOGICAL', 'description': '1. In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.\n2. In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.', 'armGroupLabels': ['The control group', 'The study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Women Health Hospital - Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohammed Khairy Ali', 'investigatorAffiliation': 'Assiut University'}}}}