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Oxidative StressNCT05443282

Ovarian Reserve and Matrix Metalloproteinases

An observational study of Oxidative Stress and Ovarian Insufficiency, Primary, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Prolidase Level, Follicle Stimulating Hormone Level and Estradiol Level
How many people
133 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2021to 7 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • Clinical diagnosis of POI for study group
  • Regularly menstruating women for control group
  • Normally developed secondary sexual characteristics

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Serum Prolidase Activity in Primary Ovarian Insufficiency

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.

Read the 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.

Being tested
Prolidase Level, Follicle Stimulating Hormone Level, Estradiol Level, Proline Level, Hydroxyproline Level
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolidase LevelDiagnostic test

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

  • Follicle Stimulating Hormone LevelDiagnostic test

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

  • Estradiol LevelDiagnostic test

    Measurement of venous blood serum level of estradiol hormone level.

  • Proline LevelDiagnostic test

    Measurement of venous blood serum level of proline level.

  • Hydroxyproline LevelDiagnostic test

    Measurement of venous blood serum level of hydroxyproline level.

  • Anti-mullerian Hormone LevelDiagnostic test

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

  • Antral Follicle CountDiagnostic test

    Ultrasonographic evaluation of antral follicle count to determine ovarian reserve.

  • Prolactine LevelDiagnostic test

    Measurement of venous blood serum prolactine hormone level.

  • Thyroid Stimulating Hormone LevelDiagnostic test

    Measurement of venous blood serum thyroid stimulating hormone level.

Study groups in NCT05443282
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: Prolidase Level; Diagnostic Test: Follicle Stimulating Hormone Level; Diagnostic Test: Estradiol Level; Diagnostic Test: Proline Level; Diagnostic Test: Hydroxyproline Level; Diagnostic Test: Anti-mullerian Hormone Level; Diagnostic Test: Antral Follicle Count; Diagnostic Test: Prolactine Level; Diagnostic Test: 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.
Receives: Diagnostic Test: Prolidase Level; Diagnostic Test: Follicle Stimulating Hormone Level; Diagnostic Test: Estradiol Level; Diagnostic Test: Proline Level; Diagnostic Test: Hydroxyproline Level; Diagnostic Test: Anti-mullerian Hormone Level; Diagnostic Test: Antral Follicle Count; Diagnostic Test: Prolactine Level; Diagnostic Test: Thyroid Stimulating Hormone Level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum prolidase level

    Units per liter

    Measured: 10 minutes

Secondary outcomes (2)

  1. Serum proline level

    Micromole per liter

    Measured: 10 minutes

  2. Serum hydroxyproline level

    Micromole per liter

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start10 Aug 2021
  3. Primary completion12 Feb 2022
  4. Study completion7 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443282
Sponsor's protocol ID
E1-20-1189
Status last verified
Jun 2022
First submitted
24 Jun 2022
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD are available which may be shared in necessary conditions.

Publications

  • 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.

    PubMed 24945456

  • 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.

    PubMed 33807517

  • 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.

    PubMed 23182561

  • Namiduru ES. Prolidase. Bratisl Lek Listy. 2016;117(8):480-5. doi: 10.4149/bll_2016_093.

    PubMed 27546702

  • 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.

    PubMed 28139522

  • 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.

    PubMed 27252278

  • 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.

    PubMed 22512465

  • 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.

    PubMed 25585505

  • 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.

    PubMed 7139961

  • 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.

    PubMed 30719458

  • 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.

    PubMed 16213850

  • Luborsky J. Ovarian autoimmune disease and ovarian autoantibodies. J Womens Health Gend Based Med. 2002 Sep;11(7):585-99. doi: 10.1089/152460902760360540.

    PubMed 12396892

  • 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.

    PubMed 15919682

  • 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.

    PubMed 22284905

  • 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.

    PubMed 19520713

Questions about this trial

What is this clinical trial studying?

An observational study of Oxidative Stress and Ovarian Insufficiency, Primary, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum prolidase level (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443282, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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