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Completed

NCT Number: NCT04762615

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

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.

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Key information

Conditions

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

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Nephrology and Transplantation Clinic University Hospital in Wrocław

Wroclaw, 50-556, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMH level measurement

Diagnostic Test

AMH level measurement using ELISA test from blood samples

Primary outcomes

  1. To compare AMH levels between three groups

    Time frame: 1 day

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

  2. Potential impact of X-ray exposition on ovarian reserve

    Time frame: 1 day

    Analysis of the impact of X-ray exposition [mSv] on AMH serum level [ng/ml]

  3. Potential impact of antiproliferative drugs on ovarian reserve

    Time frame: 1 day

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

  4. Potential impact of underlying kidney disease on ovarian reserve

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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