Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease
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Purpose
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 |
|---|
|
Infertility |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Studies of Infertility in Patients With Chronic Kidney Disease |
- concentration of sex hormone levels in plasma [ Time Frame: up to three years ] [ Designated as safety issue: No ]
- sperm motility [ Time Frame: up to three years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Samples are stored at SUS, Malmö, Sweden
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
renal transplant patients
Patients undergoing transplantation
|
|
dialysis patients
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
outpatient cohorts
Inclusion Criteria:
- GFR-levels
Exclusion Criteria:
- > 50 years old
Contacts and Locations More Information
No publications provided
| Responsible Party: | Lund University |
| ClinicalTrials.gov Identifier: | NCT01294904 History of Changes |
| Other Study ID Numbers: | CKD and infertility |
| Study First Received: | January 21, 2011 |
| Last Updated: | February 11, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Lund University:
|
Hormone Sperm Chronic kidney disease |
Additional relevant MeSH terms:
|
Infertility Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Genital Diseases, Male Genital Diseases, Female Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 18, 2013