Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT05900661
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2023-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007294', 'term': 'Inositol'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-16', 'studyFirstSubmitDate': '2023-06-04', 'studyFirstSubmitQcDate': '2023-06-04', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and maturity of oocytes retrieved', 'timeFrame': '1 month', 'description': 'Number and maturity of oocytes retrieved (M1/M2)'}], 'secondaryOutcomes': [{'measure': 'chemical pregnancy rate', 'timeFrame': '1 month', 'description': 'hcg positive'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cetrorelix', 'DHEA', 'somatotropin', 'myo inositol'], 'conditions': ['Poor Responders']}, 'descriptionModule': {'briefSummary': 'To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder', 'detailedDescription': 'Each patient will be subjected to:\n\nFull history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.\n\nRoutine labs as CBC, liver \\& kidney functions to exclude general disease as a contraindication for induction or pregnancy.\n\nBlood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .\n\nFor pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.\n\nThe serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-Infertile women who have one of the criteria of poor ovarian response as follows ;\n* Antral follicle count less than 7\n* Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25\n\nExclusion Criteria:\n\n1. Any endocrine or metabolic disorder such as polycystic ovary syndrome,\n2. Hyperprolactinemia, diabetes and thyroid dysfunction.\n3. Any pelvic pathology such as hydrosalpinx, uterine anomaly.\n4. any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia.'}, 'identificationModule': {'nctId': 'NCT05900661', 'briefTitle': 'The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'poor ovarian responders'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'myo-inositol', 'description': 'will recive Inofolic (myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks', 'interventionNames': ['Drug: myo-inositol']}, {'type': 'EXPERIMENTAL', 'label': 'Somatropin', 'description': 'Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.', 'interventionNames': ['Drug: Somatropin']}, {'type': 'EXPERIMENTAL', 'label': 'Dehydroepiandrosterone', 'description': 'DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.', 'interventionNames': ['Drug: Dehydroepiandrosterone']}], 'interventions': [{'name': 'myo-inositol', 'type': 'DRUG', 'otherNames': ['Inofolic'], 'description': 'myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks produced by a Lo.Li pharma international ,Rome.Italy .', 'armGroupLabels': ['myo-inositol']}, {'name': 'Somatropin', 'type': 'DRUG', 'description': 'growth hormone 2:Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.', 'armGroupLabels': ['Somatropin']}, {'name': 'Dehydroepiandrosterone', 'type': 'DRUG', 'otherNames': ['DHEA'], 'description': 'DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.', 'armGroupLabels': ['Dehydroepiandrosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62521', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Beni-suef university Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Sara A Salem, MD', 'role': 'CONTACT', 'email': 'sara_abdallah100@yahoo.com', 'phone': '01272842226', 'phoneExt': '02'}], 'overallOfficials': [{'name': 'Beni-Suef University', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}