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NCT01294904 Clinical Trial

Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease

Infertility Clinical Trial

Official title:
Studies of Infertility in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01294904
Other study ID # CKD and infertility
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 2011
Est. completion date August 2018

Study information
Verified date December 2018
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2018
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- GFR-levels

Exclusion Criteria:

- > 50 years old

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Dag Eckersten Malmö
Sweden SUS, Malmö, Sweden Malmö

Sponsors (1)
Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary concentration of sex hormone levels in plasma up to three years
Secondary sperm motility up to three years
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