Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-31 @ 4:21 AM
Study NCT ID:
NCT01294904
Status:
WITHDRAWN
Last Update Posted:
2018-12-21
First Post:
2011-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples are stored at SUS, Malmö, Sweden'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not active', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2011-01-21', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of sex hormone levels in plasma', 'timeFrame': 'up to three years'}], 'secondaryOutcomes': [{'measure': 'sperm motility', 'timeFrame': 'up to three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hormone', 'Sperm', 'Chronic kidney disease'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Patients with chronic kidney disease (both men and women), especially those with terminal renal failure, manifest infertility. There has been demonstrated several hormonal changes in patients on dialysis. Increased levels of luteinizing hormone (LH) has been seen in men (12). In women the opposite has been reported. The number of spermatocytes is reduced and a disturbance in maturation has been observed.\n\nThis project is aimed to study the influence of uremic milieu on fertility in men and women. The hypopituitary/hypothalamus gland axis and hormonal levels will be studied.', 'detailedDescription': 'Renal elimination of hormones and peptides. By using a human transplantation model the investigators will study changes in hormonal levels before and after a successful transplantation up to 12 months. Hormones: testosterone, SHBG (sex hormone binding globulin), LH (luteinizing hormone), FSH (follicle stimulating hormone), estradiol and inhibin B.\n\nAnalysis of sperm quality, concentration, motility, morphology and as well DNA-fragmentation index (DFI) in men with chronic kidney disease. In women the investigators will study the maturation of follicles via vaginal ultrasound. Controls are persons from a study at Dept of Reproductive Medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient cohorts', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GFR-levels\n\nExclusion Criteria:\n\n* \\> 50 years old'}, 'identificationModule': {'nctId': 'NCT01294904', 'briefTitle': 'Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Studies of Infertility in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'CKD and infertility'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'renal transplant patients', 'description': 'Patients undergoing transplantation'}, {'label': 'dialysis patients', 'description': 'hemodialysis patients and peritoneal dialysis patients. Before and after a dialysis session'}, {'label': 'patients with renal insufficiency', 'description': 'outpatient patients with chronic kidney disease stage 2, 3 and 4'}, {'label': 'Chronic kidney disease', 'description': 'outpatient cohort. Those with mild renal insufficiency'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Malmo', 'country': 'Sweden', 'facility': 'Dag Eckersten', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'SUS, Malmö, Sweden', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Anders Christensson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}