Oxidative Stress Clinical Trial
Official title:
Serum Prolidase Activity in Primary Ovarian Insufficiency
NCT number | NCT05443282 |
Other study ID # | E1-20-1189 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 10, 2021 |
Est. completion date | March 7, 2022 |
Verified date | June 2022 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | March 7, 2022 |
Est. primary completion date | February 12, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
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Committee opinion no. 605: primary ovarian insufficiency in adolescents and young women. Obstet Gynecol. 2014 Jul;124(1):193-197. doi: 10.1097/01.AOG.0000451757.51964.98. — View Citation
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Kitchener RL, Grunden AM. Prolidase function in proline metabolism and its medical and biotechnological applications. J Appl Microbiol. 2012 Aug;113(2):233-47. doi: 10.1111/j.1365-2672.2012.05310.x. Epub 2012 May 10. Review. — View Citation
La Marca A, Broekmans FJ, Volpe A, Fauser BC, Macklon NS; ESHRE Special Interest Group for Reproductive Endocrinology--AMH Round Table. Anti-Mullerian hormone (AMH): what do we still need to know? Hum Reprod. 2009 Sep;24(9):2264-75. doi: 10.1093/humrep/de — View Citation
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Practice Committee of the American Society for Reproductive Medicine. Testing and interpreting measures of ovarian reserve: a committee opinion. Fertil Steril. 2015 Mar;103(3):e9-e17. doi: 10.1016/j.fertnstert.2014.12.093. Epub 2015 Jan 10. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum prolidase level | Units per liter | 10 minutes | |
Secondary | Serum proline level | Micromole per liter | 10 minutes | |
Secondary | Serum hydroxyproline level | Micromole per liter | 10 minutes |
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