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Ovarian Reserve and Matrix Metalloproteinases

Serum Prolidase Activity in Primary Ovarian Insufficiency

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05443282
Enrollment
133
Registered
2022-07-05
Start date
2021-08-10
Completion date
2022-03-07
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Failure, Premature, Ovarian Insufficiency, Primary, Oxidative Stress

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.

Interventions

DIAGNOSTIC_TESTProlidase Level

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

DIAGNOSTIC_TESTFollicle Stimulating Hormone Level

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

DIAGNOSTIC_TESTEstradiol Level

Measurement of venous blood serum level of estradiol hormone level.

DIAGNOSTIC_TESTProline Level

Measurement of venous blood serum level of proline level.

DIAGNOSTIC_TESTHydroxyproline Level

Measurement of venous blood serum level of hydroxyproline level.

DIAGNOSTIC_TESTAnti-mullerian Hormone Level

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

DIAGNOSTIC_TESTAntral Follicle Count

Ultrasonographic evaluation of antral follicle count to determine ovarian reserve.

DIAGNOSTIC_TESTProlactine Level

Measurement of venous blood serum prolactine hormone level.

DIAGNOSTIC_TESTThyroid Stimulating Hormone Level

Measurement of venous blood serum thyroid stimulating hormone level.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum prolidase level10 minutesUnits per liter

Secondary

MeasureTime frameDescription
Serum proline level10 minutesMicromole per liter
Serum hydroxyproline level10 minutesMicromole per liter

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026