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

Completed

• Conditions: Anti-Mullerian Hormone Deficiency; Ovarian Reserve; Immunosuppression; X-rays; Effects
• Interventions: Diagnostic Test: AMH level measurement

• Registration Number: NCT04762615
• Lead Sponsor: Wroclaw Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-11-10
• Status Verified: 2020-12
• Study Completion: 2020-12-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with renal pathology without treatment	AMH level measurement	Control group
Patients with renal pathology treated with immunosuppressive drugs	AMH level measurement	Female in reproductive age suffering from renal disease that is or was previously treated with immunosuppressive drugs
Patients after renal transplantation taking immunosuppressive drugs	AMH level measurement	Female in reproductive age after renal transplantation taking immunosuppressive drugs

Primary Outcome Measures

Name	Time	Method
Potential impact of X-ray exposition on ovarian reserve	1 day	Analysis of the impact of X-ray exposition \[mSv\] on AMH serum level \[ng/ml\]
To compare AMH levels between three groups	1 day	Serum AMH levels \[ng/ml\] measured using ELISA and compared between three groups
Potential impact of antiproliferative drugs on ovarian reserve	1 day	Analysis of the impact of antiproliferative drugs on AMH serum level \[ng/ml\]
Potential impact of underlying kidney disease on ovarian reserve	1 day	Analysis of the impact of underlying kidney disease (including SLE) on AMH serum level \[ng/ml\]

Trial Locations

Locations (1)

Nephrology and Transplantation Clinic University Hospital in Wrocław; 🇵🇱 Wrocław, Poland