Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01294904|
Recruitment Status : Unknown
Verified January 2011 by Lund University.
Recruitment status was: Enrolling by invitation
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
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.
This 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.
|Condition or disease|
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.
Analysis 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Studies of Infertility in Patients With Chronic Kidney Disease|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||August 2016|
renal transplant patients
Patients undergoing transplantation
hemodialysis patients and peritoneal dialysis patients. Before and after a dialysis session
patients with renal insufficiency
outpatient patients with chronic kidney disease stage 2, 3 and 4
Chronic kidney disease
outpatient cohort. Those with mild renal insufficiency
- concentration of sex hormone levels in plasma [ Time Frame: up to three years ]
- sperm motility [ Time Frame: up to three years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294904
|SUS, Malmö, Sweden|
|Principal Investigator:||Anders Christensson, MD||Lund University|