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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04762615
Enrollment
153
Registered
2021-02-21
Start date
2018-06-01
Completion date
2020-12-01
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

AMH, Immunosuppression, Ovarian Reserve, X-Ray effects

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.

Interventions

DIAGNOSTIC_TESTAMH level measurement

AMH level measurement using ELISA test from blood samples

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To compare AMH levels between three groups1 daySerum AMH levels \[ng/ml\] measured using ELISA and compared between three groups
Potential impact of X-ray exposition on ovarian reserve1 dayAnalysis of the impact of X-ray exposition \[mSv\] on AMH serum level \[ng/ml\]
Potential impact of antiproliferative drugs on ovarian reserve1 dayAnalysis of the impact of antiproliferative drugs on AMH serum level \[ng/ml\]
Potential impact of underlying kidney disease on ovarian reserve1 dayAnalysis of the impact of underlying kidney disease (including SLE) on AMH serum level \[ng/ml\]

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026