InfertilityNCT01294904
Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease
An observational study of Infertility, run by Lund University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2011to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: outpatient cohorts
Who may be able to join
- GFR-levels
Who cannot join
- > 50 years old
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Keywords
- Hormone, Sperm, Chronic kidney disease
- Medical subject headings
- Infertility, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of sex hormone levels in plasma
Measured: up to three years
Secondary outcomes (1)
sperm motility
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2017
- Study completionAug 2018 (estimated)
Why it stopped: Not active
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Christensson, MD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294904
- Sponsor's protocol ID
- CKD and infertility
- Status last verified
- Dec 2018
- First submitted
- 21 Jan 2011
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Infertility in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01294904
- Acronym / sponsor ID
- CKD and infertility
- Conditions
- Infertility
- Keywords
- Hormone, Sperm, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not active
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- outpatient cohorts
Key inclusion criteria (1 listed)
- GFR-levels
Key exclusion criteria (1 listed)
- > 50 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concentration of sex hormone levels in plasma
Time frame: up to three years
1 secondary outcome
sperm motility
Time frame: up to three years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Christensson, MD principal investigator
Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Lund University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of sex hormone levels in plasma (time frame: up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.