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

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04762615
• Other study ID #: 451/2018
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 1, 2020
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• AMH level measurement
AMH level measurement using ELISA test from blood samples

Locations

Country	Name	City	State
Poland	Nephrology and Transplantation Clinic University Hospital in Wroclaw	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare AMH levels between three groups	Serum AMH levels [ng/ml] measured using ELISA and compared between three groups	1 day
Primary	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
Primary	Potential impact of antiproliferative drugs on ovarian reserve	Analysis of the impact of antiproliferative drugs on AMH serum level [ng/ml]	1 day
Primary	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