Clinical trial NCT05443282: Ovarian Reserve and Matrix Metalloproteinases
Official title: Serum Prolidase Activity in Primary Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Ovarian Insufficiency, Primary
Ovarian Failure, Premature
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes a total of 133 participants. The study group consists of 68 women with the diagnosis of idiopathic POI, and the control group consists of 65 normally menstruating women.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum prolidase level
timeFrame: 10 minutes
Secondary outcomes:
measure: Serum proline level
timeFrame: 10 minutes
measure: Serum hydroxyproline level
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Esin Merve Erol Koç, MD
role: PRINCIPAL_INVESTIGATOR
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