Ovarian Reserve and Matrix Metalloproteinases
- Conditions
- Oxidative StressOvarian Failure, PrematureOvarian Insufficiency, Primary
- Interventions
- Diagnostic Test: Prolidase LevelDiagnostic Test: Follicle Stimulating Hormone LevelDiagnostic Test: Estradiol LevelDiagnostic Test: Proline LevelDiagnostic Test: Hydroxyproline LevelDiagnostic Test: Anti-mullerian Hormone LevelDiagnostic Test: Antral Follicle CountDiagnostic Test: Prolactine LevelDiagnostic Test: Thyroid Stimulating Hormone Level
- Registration Number
- NCT05443282
- Lead Sponsor
- Ankara City Hospital Bilkent
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 133
- Clinical diagnosis of POI for study group
- Regularly menstruating women for control group
- Normally developed secondary sexual characteristics
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description POI group (Study group) Proline Level * 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. POI group (Study group) Follicle Stimulating Hormone Level * 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. POI group (Study group) Anti-mullerian Hormone Level * 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. POI group (Study group) Antral Follicle Count * 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. POI group (Study group) Prolidase Level * 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. POI group (Study group) Estradiol Level * 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. POI group (Study group) Hydroxyproline Level * 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. Normally menstruating women (Control group) Estradiol Level * 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. Normally menstruating women (Control group) Proline Level * 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. Normally menstruating women (Control group) Hydroxyproline Level * 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. Normally menstruating women (Control group) Antral Follicle Count * 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. POI group (Study group) Thyroid Stimulating Hormone Level * 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. POI group (Study group) Prolactine Level * 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. Normally menstruating women (Control group) Follicle Stimulating Hormone Level * 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. Normally menstruating women (Control group) Prolactine Level * 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. Normally menstruating women (Control group) Prolidase Level * 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. Normally menstruating women (Control group) Thyroid Stimulating Hormone Level * 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. Normally menstruating women (Control group) Anti-mullerian Hormone Level * 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.
- Primary Outcome Measures
Name Time Method Serum prolidase level 10 minutes Units per liter
- Secondary Outcome Measures
Name Time Method Serum proline level 10 minutes Micromole per liter
Serum hydroxyproline level 10 minutes Micromole per liter
Trial Locations
- Locations (1)
Ankara City Hospital
🇹🇷Ankara, Turkey