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

NCT04762615 | Completed

• 1 other identifier: 451/2018
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anti-Mullerian Hormone Deficiency; Immunosuppression; Ovarian Reserve; X-rays; Effects

Keywords

AMH; Immunosuppression; Ovarian Reserve; X-Ray effects

Outcome Measures

Primary Outcomes (4)

• To compare AMH levels between three groups

  Serum AMH levels \[ng/ml\] measured using ELISA and compared between three groups

  1 day

• Potential impact of X-ray exposition on ovarian reserve

  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

  Analysis of the impact of antiproliferative drugs on AMH serum level \[ng/ml\]

  1 day

• Potential impact of underlying kidney disease on ovarian reserve

  Analysis of the impact of underlying kidney disease (including SLE) on AMH serum level \[ng/ml\]

  1 day

Study Arms (3)

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

Patients with renal pathology without treatment

Control group

Diagnostic Test: AMH level measurement

Patients after renal transplantation taking immunosuppressive drugs

Female in reproductive age after renal transplantation taking immunosuppressive drugs

Diagnostic Test: AMH level measurement

Interventions

AMH level measurement DIAGNOSTIC_TEST

AMH level measurement using ELISA test from blood samples

Patients after renal transplantation taking immunosuppressive drugs; Patients with renal pathology treated with immunosuppressive drugs; Patients with renal pathology without treatment

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Conscious written approval
• Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
• Age above 18 years old

You may not qualify if:

• Irregular menstrual cycles
• Menopause
• PCOS
• Chemiotherapy or radiotherapy in the past
• Surgical interventions within ovaries
• Hypogonadotropic hypogonadism
• Folliculoma
• Age under 18 years old

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Nephrology and Transplantation Clinic University Hospital in Wrocław

Wroclaw, 50-556, Poland

Location

Study Officials

• Julia Rasała, MD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: June 1, 2018
• Primary Completion: November 10, 2019
• Study Completion: December 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)