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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Lund University
ClinicalTrials.gov Identifier:
NCT01294904
First received: January 21, 2011
Last updated: February 11, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • concentration of sex hormone levels in plasma [ Time Frame: up to three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

outpatient cohorts

Criteria

Inclusion Criteria:

  • GFR-levels

Exclusion Criteria:

  • > 50 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294904

Locations
Sweden
SUS, Malmö, Sweden
Malmö, Sweden
Dag Eckersten
Malmö, Sweden
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Anders Christensson, MD Lund University
  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:
Kidney Diseases
Renal Insufficiency, Chronic
Infertility
Urologic Diseases
Renal Insufficiency
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014