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

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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
Sponsor:
Information provided by:
Lund University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease
Infertility

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. concentration of sex hormone levels in plasma [ Time Frame: up to three years ]

Secondary Outcome Measures :
  1. sperm motility [ Time Frame: up to three years ]

Biospecimen Retention:   Samples Without DNA
Samples are stored at SUS, Malmö, Sweden

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
outpatient cohorts
Criteria

Inclusion Criteria:

  • GFR-levels

Exclusion Criteria:

  • > 50 years old
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Sweden
Dag Eckersten
Malmö, Sweden
SUS, Malmö, Sweden
Malmö, Sweden
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Anders Christensson, MD Lund University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT01294904     History of Changes
Other Study ID Numbers: CKD and infertility
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: January 2011

Keywords provided by Lund University:
Hormone
Sperm
Chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Infertility
Urologic Diseases
 Renal Insufficiency
Genital Diseases, Male
Genital Diseases, Female