Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients

February 18, 2021 updated by: Wroclaw Medical University

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Wrocław, Poland, 50-556
        • Nephrology and Transplantation Clinic University Hospital in Wrocław

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Regularly menstruating female patients suffering from renal pathology or after renal transplantation

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Diagnostic test: AMH level measurement
AMH level measurement using ELISA test from blood samples
Patients with renal pathology without treatment
Control group
Diagnostic test: AMH level measurement
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
Diagnostic test: AMH level measurement
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

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Investigators

  • Principal Investigator: Julia Rasała, MD, Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

November 10, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

December 1, 2020

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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