NCT01294904

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

6.3 years

First QC Date

January 21, 2011

Last Update Submit

December 19, 2018

Conditions

Infertility

Keywords

HormoneSpermChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • concentration of sex hormone levels in plasma

    up to three years

Secondary Outcomes (1)

  • sperm motility

    up to three years

Study Arms (4)

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

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

outpatient cohorts

You may qualify if:

  • GFR-levels

You may not qualify if:

  • \> 50 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dag Eckersten

Malmo, Sweden

Location

SUS, Malmö, Sweden

Malmo, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples are stored at SUS, Malmö, Sweden

MeSH Terms

Conditions

InfertilityRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anders Christensson, MD

    Lund University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2017

Study Completion

August 1, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Locations

SE(2)