Ovarian Reserve and Matrix Metalloproteinases

A

Ankara City Hospital

Status

Completed

Conditions

Ovarian Insufficiency, Primary
Ovarian Failure, Premature
Oxidative Stress

Treatments

Diagnostic Test: Antral Follicle Count
Diagnostic Test: Hydroxyproline Level
Diagnostic Test: Prolidase Level
Diagnostic Test: Proline Level
Diagnostic Test: Follicle Stimulating Hormone Level
Diagnostic Test: Anti-mullerian Hormone Level
Diagnostic Test: Thyroid Stimulating Hormone Level
Diagnostic Test: Prolactine Level
Diagnostic Test: Estradiol Level

Study type

Observational

Funder types

Other

Identifiers

NCT05443282
E1-20-1189

Details and patient eligibility

About

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.

Full description

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.

Enrollment

133 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

133 participants in 2 patient groups

POI group (Study group)
Description:
The study group included 68 women with POI. The POI cases had been diagnosed as idiopathic POI. The POI diagnosis was based on the presence of amenorrhea before the age of 40, increased serum FSH level higher than 40 mIU/ml, and decreased estradiol levels lesser than 50 pg/mL.
Treatment:
Diagnostic Test: Estradiol Level
Diagnostic Test: Prolactine Level
Diagnostic Test: Thyroid Stimulating Hormone Level
Diagnostic Test: Anti-mullerian Hormone Level
Diagnostic Test: Follicle Stimulating Hormone Level
Diagnostic Test: Proline Level
Diagnostic Test: Antral Follicle Count
Diagnostic Test: Hydroxyproline Level
Diagnostic Test: Prolidase Level
Normally menstruating women (Control group)
Description:
Control group consisted of 65 healthy, regularly menstruating women. The women were at the age of lesser than 40 years old. The women were recruited consecutively from those that applied to outpatient clinics to get counselling for family planning.
Treatment:
Diagnostic Test: Estradiol Level
Diagnostic Test: Prolactine Level
Diagnostic Test: Thyroid Stimulating Hormone Level
Diagnostic Test: Anti-mullerian Hormone Level
Diagnostic Test: Follicle Stimulating Hormone Level
Diagnostic Test: Proline Level
Diagnostic Test: Antral Follicle Count
Diagnostic Test: Hydroxyproline Level
Diagnostic Test: Prolidase Level

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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