Study Results
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Basic Information
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COMPLETED
133 participants
OBSERVATIONAL
2021-08-10
2022-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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POI group (Study group)
* 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.
Prolidase Level
Measurement of venous blood serum level of prolidase enzyme level by ELISA method.
Follicle Stimulating Hormone Level
Measurement of venous blood serum level of follicle stimulating hormone level.
Estradiol Level
Measurement of venous blood serum level of estradiol hormone level.
Proline Level
Measurement of venous blood serum level of proline level.
Hydroxyproline Level
Measurement of venous blood serum level of hydroxyproline level.
Anti-mullerian Hormone Level
Measurement of venous blood serum level of anti-mullerian hormone level.
Antral Follicle Count
Ultrasonographic evaluation of antral follicle count to determine ovarian reserve.
Prolactine Level
Measurement of venous blood serum prolactine hormone level.
Thyroid Stimulating Hormone Level
Measurement of venous blood serum thyroid stimulating hormone level.
Normally menstruating women (Control group)
* 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.
Prolidase Level
Measurement of venous blood serum level of prolidase enzyme level by ELISA method.
Follicle Stimulating Hormone Level
Measurement of venous blood serum level of follicle stimulating hormone level.
Estradiol Level
Measurement of venous blood serum level of estradiol hormone level.
Proline Level
Measurement of venous blood serum level of proline level.
Hydroxyproline Level
Measurement of venous blood serum level of hydroxyproline level.
Anti-mullerian Hormone Level
Measurement of venous blood serum level of anti-mullerian hormone level.
Antral Follicle Count
Ultrasonographic evaluation of antral follicle count to determine ovarian reserve.
Prolactine Level
Measurement of venous blood serum prolactine hormone level.
Thyroid Stimulating Hormone Level
Measurement of venous blood serum thyroid stimulating hormone level.
Interventions
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Prolidase Level
Measurement of venous blood serum level of prolidase enzyme level by ELISA method.
Follicle Stimulating Hormone Level
Measurement of venous blood serum level of follicle stimulating hormone level.
Estradiol Level
Measurement of venous blood serum level of estradiol hormone level.
Proline Level
Measurement of venous blood serum level of proline level.
Hydroxyproline Level
Measurement of venous blood serum level of hydroxyproline level.
Anti-mullerian Hormone Level
Measurement of venous blood serum level of anti-mullerian hormone level.
Antral Follicle Count
Ultrasonographic evaluation of antral follicle count to determine ovarian reserve.
Prolactine Level
Measurement of venous blood serum prolactine hormone level.
Thyroid Stimulating Hormone Level
Measurement of venous blood serum thyroid stimulating hormone level.
Eligibility Criteria
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Inclusion Criteria
* Regularly menstruating women for control group
* Normally developed secondary sexual characteristics
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Esin Merve Erol Koç
Medical Doctor
Principal Investigators
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Esin Merve Erol Koç, MD
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Locations
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Ankara City Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
Szeliga A, Calik-Ksepka A, Maciejewska-Jeske M, Grymowicz M, Smolarczyk K, Kostrzak A, Smolarczyk R, Rudnicka E, Meczekalski B. Autoimmune Diseases in Patients with Premature Ovarian Insufficiency-Our Current State of Knowledge. Int J Mol Sci. 2021 Mar 5;22(5):2594. doi: 10.3390/ijms22052594.
Rafique S, Sterling EW, Nelson LM. A new approach to primary ovarian insufficiency. Obstet Gynecol Clin North Am. 2012 Dec;39(4):567-86. doi: 10.1016/j.ogc.2012.09.007.
Namiduru ES. Prolidase. Bratisl Lek Listy. 2016;117(8):480-5. doi: 10.4149/bll_2016_093.
Zhou F, Shi LB, Zhang SY. Ovarian Fibrosis: A Phenomenon of Concern. Chin Med J (Engl). 2017 Feb 5;130(3):365-371. doi: 10.4103/0366-6999.198931.
Hart RJ. Physiological Aspects of Female Fertility: Role of the Environment, Modern Lifestyle, and Genetics. Physiol Rev. 2016 Jul;96(3):873-909. doi: 10.1152/physrev.00023.2015.
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.
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.
Myara I, Charpentier C, Lemonnier A. Optimal conditions for prolidase assay by proline colorimetric determination: application to iminodipeptiduria. Clin Chim Acta. 1982 Oct 27;125(2):193-205. doi: 10.1016/0009-8981(82)90196-6.
Huang Y, Hu C, Ye H, Luo R, Fu X, Li X, Huang J, Chen W, Zheng Y. Inflamm-Aging: A New Mechanism Affecting Premature Ovarian Insufficiency. J Immunol Res. 2019 Jan 2;2019:8069898. doi: 10.1155/2019/8069898. eCollection 2019.
Bakalov VK, Anasti JN, Calis KA, Vanderhoof VH, Premkumar A, Chen S, Furmaniak J, Smith BR, Merino MJ, Nelson LM. Autoimmune oophoritis as a mechanism of follicular dysfunction in women with 46,XX spontaneous premature ovarian failure. Fertil Steril. 2005 Oct;84(4):958-65. doi: 10.1016/j.fertnstert.2005.04.060.
Luborsky J. Ovarian autoimmune disease and ovarian autoantibodies. J Womens Health Gend Based Med. 2002 Sep;11(7):585-99. doi: 10.1089/152460902760360540.
Goswami D, Conway GS. Premature ovarian failure. Hum Reprod Update. 2005 Jul-Aug;11(4):391-410. doi: 10.1093/humupd/dmi012. Epub 2005 May 26.
Carp HJ, Selmi C, Shoenfeld Y. The autoimmune bases of infertility and pregnancy loss. J Autoimmun. 2012 May;38(2-3):J266-74. doi: 10.1016/j.jaut.2011.11.016. Epub 2012 Jan 27.
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/dep210. Epub 2009 Jun 11.
Other Identifiers
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E1-20-1189
Identifier Type: -
Identifier Source: org_study_id
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