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

Study Overview
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Brief Summary
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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.

Official Title
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Impact of the Immunosuppressive Treatment, X-ray Exposition and Renal Pathology on Ovarian Reserve in Young Women

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

Intervention / Treatment
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* Diagnostic Test: AMH level measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with renal pathology treated with immunosuppressive drugs<br>Female in reproductive age suffering from renal disease that is or was previously treated with immunosuppressive drugs | Diagnostic Test: AMH level measurement<br>* AMH level measurement using ELISA test from blood samples<br>|
| Patients with renal pathology without treatment<br>Control group | Diagnostic Test: AMH level measurement<br>* AMH level measurement using ELISA test from blood samples<br>|
| Patients after renal transplantation taking immunosuppressive drugs<br>Female in reproductive age after renal transplantation taking immunosuppressive drugs | Diagnostic Test: AMH level measurement<br>* AMH level measurement using ELISA test from blood samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMH, Immunosuppression, Ovarian Reserve, X-Ray effects