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

NCT ID: NCT01294904

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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Hormone Sperm Chronic kidney disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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renal transplant patients

Patients undergoing transplantation

No interventions assigned to this group

dialysis patients

hemodialysis patients and peritoneal dialysis patients. Before and after a dialysis session

No interventions assigned to this group

patients with renal insufficiency

outpatient patients with chronic kidney disease stage 2, 3 and 4

No interventions assigned to this group

Chronic kidney disease

outpatient cohort. Those with mild renal insufficiency

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* GFR-levels

Exclusion Criteria

* \> 50 years old
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Christensson, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Dag Eckersten

Malmo, , Sweden

Site Status

SUS, Malmö, Sweden

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CKD and infertility

Identifier Type: -

Identifier Source: org_study_id