- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762615
Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients
Impact of the Immunosuppressive Treatment, X-ray Exposition and Renal Pathology on Ovarian Reserve in Young Women
Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve.
Every female with renal disease regularly menstruating that met exclusion criteria could have participated. The aim was to assess ovarian reserve in female patients with normal menstrual cycle and kidney disease, including kidney transplant recipients.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Wrocław, Poland, 50-556
- Nephrology and Transplantation Clinic University Hospital in Wrocław
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Conscious written approval
- Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
- Age above 18 years old
Exclusion Criteria:
- Irregular menstrual cycles
- Menopause
- PCOS
- Chemiotherapy or radiotherapy in the past
- Surgical interventions within ovaries
- Hypogonadotropic hypogonadism
- Folliculoma
- Age under 18 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with renal pathology treated with immunosuppressive drugs
Female in reproductive age suffering from renal disease that is or was previously treated with immunosuppressive drugs
|
AMH level measurement using ELISA test from blood samples
|
Patients with renal pathology without treatment
Control group
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AMH level measurement using ELISA test from blood samples
|
Patients after renal transplantation taking immunosuppressive drugs
Female in reproductive age after renal transplantation taking immunosuppressive drugs
|
AMH level measurement using ELISA test from blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare AMH levels between three groups
Time Frame: 1 day
|
Serum AMH levels [ng/ml] measured using ELISA and compared between three groups
|
1 day
|
Potential impact of X-ray exposition on ovarian reserve
Time Frame: 1 day
|
Analysis of the impact of X-ray exposition [mSv] on AMH serum level [ng/ml]
|
1 day
|
Potential impact of antiproliferative drugs on ovarian reserve
Time Frame: 1 day
|
Analysis of the impact of antiproliferative drugs on AMH serum level [ng/ml]
|
1 day
|
Potential impact of underlying kidney disease on ovarian reserve
Time Frame: 1 day
|
Analysis of the impact of underlying kidney disease (including SLE) on AMH serum level [ng/ml]
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Rasała, MD, Wroclaw Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 451/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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