- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01294904
Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease
Studies of Infertility in Patients With Chronic Kidney Disease
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Malmö, Sverige
- Dag Eckersten
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Malmö, Sverige
- SUS, Malmö, Sweden
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- GFR-levels
Exclusion Criteria:
- > 50 years old
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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renal transplant patients
Patients undergoing transplantation
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dialysis patients
hemodialysis patients and peritoneal dialysis patients.
Before and after a dialysis session
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patients with renal insufficiency
outpatient patients with chronic kidney disease stage 2, 3 and 4
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Chronic kidney disease
outpatient cohort.
Those with mild renal insufficiency
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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concentration of sex hormone levels in plasma
Tidsramme: up to three years
|
up to three years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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sperm motility
Tidsramme: up to three years
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up to three years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Anders Christensson, MD, Lund University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CKD and infertility
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