Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-06 @ 7:00 AM
Study NCT ID:
NCT03291860
Status:
UNKNOWN
Last Update Posted:
2017-09-25
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimullerian Hormone as an Indicator for 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI.', 'timeFrame': '1 month (1 cycle)', 'description': 'Measurement of AMH level in patients undergoing controlled ovarian stimulation prior to ICSI using long GnRH agonist protocol. Level will be compared between good and poor responders.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility assistance.\n\nInvestigators explored its correlation with oocytes retrieval after long GnRH agonist protocol for stimulation, in younger and older infertile population. Methods: This prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes were measured as good (5 to 19 oocytes) and bad responders.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sixty six women undergoing ICSI were enrolled in and a written informed consent was obtained from each participant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:20-40 years old\n2. BMI:20-40kg/m\n3. Normal baseline hormonal profile (on the 2nd day of the cycle)\n\n * FSH: 2.5-10.2mlU/ml\n * LH:1.9-12.5mlU/ml\n * Estradiol (E2): \\<50pg/ml\n4. No Endometriosis by laparoscopy\n5. No prior ovarian surgery; overectomy, ovariectomy or oophrectomy\n6. Female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy\n\nExclusion Criteria:\n\n* 1\\. Age: \\<20 or \\>40 years old 2. BMI: \\<20 or \\>40kg/m 3. Female subjects with any contraindication for pregnancy. 4. Female subjects with history of tumors of the hypothalamus \\& pituitary gland.\n\n 5\\. Female subjects with history of ovarian, uterine or mammary cancer. 6. Female subjects with history of hypersensitivity to the active substance of the medications used for ovarian stimulation.\n\n 7\\. Abnormal baseline hormonal profile 8. Endometriosis by laparoscopy 9. Previous ovarian surgery; overectomy, ovariectomy or oophrectomy 10. Female subjects with abnormal gynecological bleeding of unknown etiology'}, 'identificationModule': {'nctId': 'NCT03291860', 'briefTitle': 'Antimullerian Hormone as an Indicator for Ovarian Response', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Antimullerian Hormone as an Indicator fo Ovarian Response in Women Receiving Long GnRH Agonist Protocol in Intracytoplasmic Sperm Injection Cycles', 'orgStudyIdInfo': {'id': 'Antimullerian hormone'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ovum retrievum', 'type': 'PROCEDURE', 'description': 'assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed M Selim, MBBCh', 'role': 'CONTACT', 'email': 'dr.ahmedselim_89@yahoo.com', 'phone': '00201123122003'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ahmed Mohammed Selim', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}