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Serum Antimullerian Hormone Levels Among Epileptic Patients

Primary Purpose

Epilepsy, Reproductive Issues

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
serum antimullerian hormone
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring anti-mullerian hormone, epilepsy, adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy and epileptic volunteer females
  • Ages between 12-18
  • After menarche

Exclusion Criteria:

  • ovarian surgery,
  • history of radiotherapy
  • history of chemotherapy,
  • before menarche

Sites / Locations

  • Near East University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

participants with epilepsy

healthy participants

Arm Description

healthy, menstruating females between 12-18 ages

epileptic, menstruating females between 12-18 ages

Outcomes

Primary Outcome Measures

serum anti-mullerian hormone levels
The comparison of serum levels of anti-mullerian hormone between epileptic and healthy groups

Secondary Outcome Measures

Full Information

First Posted
July 2, 2021
Last Updated
October 1, 2021
Sponsor
Near East University, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05066360
Brief Title
Serum Antimullerian Hormone Levels Among Epileptic Patients
Official Title
Investigation of Serum Antimullerian Hormone Levels in Adolescent Epilepsy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Anticipated)
Study Completion Date
February 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The production of AMH starts in granulosa cells before birth and the levels within the serum decreases towards the menapouse. The levels of AMH do not change throughout the menstruation cycle hovewer, it can be affected in cases related to body mass index (BMI), polycyctic ovarian syndrome (PCOS). The lower levels of AMH had been documented after ovarian surgery, radiotheraphy and chemotheraphy. AMH is a member of Transforming Growth Faktor β (TGF- β ) and it has receptors in brain structures including hyppocammpus. It is highly active neurophysiologically and it has a protective effect against N-methyl-D -aspartate related neuronal injury that is demonstrated both in vivo and in vitro studies. As a result, being a neuroactive hormone; AMH may have an effect on seizures within epileptic patients or serum AMH levels may be effected in epileptic patients when compared with healthy ones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Reproductive Issues
Keywords
anti-mullerian hormone, epilepsy, adolescent

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups (epileptic and healthy participants)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
participants with epilepsy
Arm Type
Other
Arm Description
healthy, menstruating females between 12-18 ages
Arm Title
healthy participants
Arm Type
Other
Arm Description
epileptic, menstruating females between 12-18 ages
Intervention Type
Diagnostic Test
Intervention Name(s)
serum antimullerian hormone
Intervention Description
serum antimullerian hormone will be analyzed for all participants
Primary Outcome Measure Information:
Title
serum anti-mullerian hormone levels
Description
The comparison of serum levels of anti-mullerian hormone between epileptic and healthy groups
Time Frame
baseline, at the time of examination

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy and epileptic volunteer females Ages between 12-18 After menarche Exclusion Criteria: ovarian surgery, history of radiotherapy history of chemotherapy, before menarche
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALİ ÖZAY, Assoc Prof
Organizational Affiliation
Near East University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Near East University Faculty of Medicine
City
Nicosia
ZIP/Postal Code
99138
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Serum antimullerian hormone levels will be shared for both groups
Citations:
PubMed Identifier
21724534
Citation
Karkanaki A, Vosnakis C, Panidis D. The clinical significance of anti-Mullerian hormone evaluation in gynecological endocrinology. Hormones (Athens). 2011 Apr-Jun;10(2):95-103. doi: 10.14310/horm.2002.1299.
Results Reference
background
PubMed Identifier
25585505
Citation
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.
Results Reference
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PubMed Identifier
16388003
Citation
Visser JA, de Jong FH, Laven JS, Themmen AP. Anti-Mullerian hormone: a new marker for ovarian function. Reproduction. 2006 Jan;131(1):1-9. doi: 10.1530/rep.1.00529.
Results Reference
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PubMed Identifier
26753790
Citation
Cimino I, Casoni F, Liu X, Messina A, Parkash J, Jamin SP, Catteau-Jonard S, Collier F, Baroncini M, Dewailly D, Pigny P, Prescott M, Campbell R, Herbison AE, Prevot V, Giacobini P. Novel role for anti-Mullerian hormone in the regulation of GnRH neuron excitability and hormone secretion. Nat Commun. 2016 Jan 12;7:10055. doi: 10.1038/ncomms10055.
Results Reference
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PubMed Identifier
18796535
Citation
Lebeurrier N, Launay S, Macrez R, Maubert E, Legros H, Leclerc A, Jamin SP, Picard JY, Marret S, Laudenbach V, Berger P, Sonderegger P, Ali C, di Clemente N, Vivien D. Anti-Mullerian-hormone-dependent regulation of the brain serine-protease inhibitor neuroserpin. J Cell Sci. 2008 Oct 15;121(Pt 20):3357-65. doi: 10.1242/jcs.031872. Epub 2008 Sep 16.
Results Reference
background
PubMed Identifier
23237902
Citation
Harden CL, Pennell PB. Neuroendocrine considerations in the treatment of men and women with epilepsy. Lancet Neurol. 2013 Jan;12(1):72-83. doi: 10.1016/S1474-4422(12)70239-9. Erratum In: Lancet Neurol. 2013 Feb;12(2):128. Dosage error in article text.
Results Reference
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PubMed Identifier
12939416
Citation
Harden CL, Koppel BS, Herzog AG, Nikolov BG, Hauser WA. Seizure frequency is associated with age at menopause in women with epilepsy. Neurology. 2003 Aug 26;61(4):451-5. doi: 10.1212/01.wnl.0000081228.48016.44.
Results Reference
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PubMed Identifier
8162389
Citation
Meo R, Bilo L, Nappi C, Tommaselli AP, Valentino R, Nocerino C, Striano S, Buscaino GA. Derangement of the hypothalamic GnRH pulse generator in women with epilepsy. Seizure. 1993 Sep;2(3):241-52. doi: 10.1016/s1059-1311(05)80134-7.
Results Reference
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PubMed Identifier
14595652
Citation
Herzog AG, Coleman AE, Jacobs AR, Klein P, Friedman MN, Drislane FW, Ransil BJ, Schomer DL. Interictal EEG discharges, reproductive hormones, and menstrual disorders in epilepsy. Ann Neurol. 2003 Nov;54(5):625-37. doi: 10.1002/ana.10732. Erratum In: Ann Neurol. 2004 Jan;55(1):148.
Results Reference
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PubMed Identifier
16981860
Citation
Quigg M, Kiely JM, Johnson ML, Straume M, Bertram EH, Evans WS. Interictal and postictal circadian and ultradian luteinizing hormone secretion in men with temporal lobe epilepsy. Epilepsia. 2006 Sep;47(9):1452-9. doi: 10.1111/j.1528-1167.2006.00617.x.
Results Reference
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PubMed Identifier
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Citation
Harden CL, Pennell PB, French JA, Davis A, Lau C, Llewellyn N, Kaufman B, Bagiella E, Kirshenbaum A. Anti-mullerian hormone is higher in seizure-free women with epilepsy compared to those with ongoing seizures. Epilepsy Res. 2016 Nov;127:66-71. doi: 10.1016/j.eplepsyres.2016.08.003. Epub 2016 Aug 17.
Results Reference
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Serum Antimullerian Hormone Levels Among Epileptic Patients

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