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NCT Number: NCT05443282

Ovarian Reserve and Matrix Metalloproteinases

Primary Ovarian Insufficiency (POI) is dysfunction of ovaries before 40 years of age. It has been reported that genetic factors, endocrine disorders, previous pelvic surgeries, chemotherapy and radiotherapy, and autoimmune mechanisms play a role in 10%, however the etiology has not been clarified in 90% of the cases. Oxidative stress and autoimmunity has been shown to be responsible in the etiopathogenesis of POI. Prolidase is an imidodipeptidase. Prolidase was shown to be related with oxidative stress and autoimmune diseases in previous studies. In addition, it is thought that the level of prolidase plays a role both in the etiopathogenesis and progression of diseases. This study aims to investigate the level of prolidase enzyme in women with POI.

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Key information

About this study

Primary Ovarian Insufficiency (POI) is dysfunction of ovaries before 40 years of age. It has been reported that genetic factors, endocrine disorders, previous pelvic surgeries, chemotherapy and radiotherapy, and autoimmune mechanisms play a role in 10%, however the etiology has not been clarified in 90% of the cases that are diagnosed as idiopathic POI. Recent studies concentrated on the role of immune mechanisms in idiopathic POI. Prolidase is a matrix metalloproteinase that plays a role in various metabolic processes and is responsible for the destruction of dipeptides containing proline and hydroxyproline. The prolidase has been shown to be related with oxidative stress and autoimmune diseases in previous studies. Prolidase was shown to be a diagnostic and prognostic value in a number of diseases. Proline and hydroxyproline are metabolites produced through the prolidase activity. Proline itself is also considered as a kind of metabolic stress indicator. On the other hand, free proline in the medium is known to inhibit the prolidase enzyme activity. Therefore, simultaneous measurement of proline and hydroxyproline levels in the medium enables to more accurately calculate the prolidase activity. This study aim to analyze the prolidase level in POI patients compared to healthy menstruating women. Besides the prolidase activity, we also aim to measure proline and hydroxyproline levels in order to provide the calibration for accurate results in terms of prolidase activity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical diagnosis of POI for study group
  • Regularly menstruating women for control group
  • Normally developed secondary sexual characteristics

Exclusion criteria

  • Cardiovascular diseases including hypertension
  • Type 1 or type 2 diabetes mellitus
  • Morbid obesity
  • Primary adrenal insufficiency
  • Uterine fibroids
  • Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
  • Hepatic dysfunctions
  • Renal insufficiency
  • Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
  • Neurologic diseases
  • Psychiatric disorders
  • Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
  • History of any malignancy
  • History of exposure to chemotherapeutic agents or radiotherapy

Treatment and study plan

Prolidase Level

Diagnostic Test

Measurement of venous blood serum level of prolidase enzyme level by ELISA method.

Follicle Stimulating Hormone Level

Diagnostic Test

Measurement of venous blood serum level of follicle stimulating hormone level.

Estradiol Level

Diagnostic Test

Measurement of venous blood serum level of estradiol hormone level.

Proline Level

Diagnostic Test

Measurement of venous blood serum level of proline level.

Hydroxyproline Level

Diagnostic Test

Measurement of venous blood serum level of hydroxyproline level.

Anti-mullerian Hormone Level

Diagnostic Test

Measurement of venous blood serum level of anti-mullerian hormone level.

Antral Follicle Count

Diagnostic Test

Ultrasonographic evaluation of antral follicle count to determine ovarian reserve.

Prolactine Level

Diagnostic Test

Measurement of venous blood serum prolactine hormone level.

Thyroid Stimulating Hormone Level

Diagnostic Test

Measurement of venous blood serum thyroid stimulating hormone level.

Primary outcomes

  1. Serum prolidase level

    Time frame: 10 minutes

    Units per liter

Secondary outcomes

  1. Serum proline level

    Time frame: 10 minutes

    Micromole per liter

  2. Serum hydroxyproline level

    Time frame: 10 minutes

    Micromole per liter

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Serum Prolidase Activity in Primary Ovarian Insufficiency

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

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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