Serum Antimullerian Hormone Levels Among Epileptic Patients

NCT05066360 | Completed

• 1 other identifier: AMH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Reproductive Issues

Keywords

anti-mullerian hormone; epilepsy; adolescent

Outcome Measures

Primary Outcomes (1)

• serum anti-mullerian hormone levels

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

  baseline, at the time of examination

Study Arms (2)

participants with epilepsy

OTHER

healthy, menstruating females between 12-18 ages

Diagnostic Test: serum antimullerian hormone

healthy participants

OTHER

epileptic, menstruating females between 12-18 ages

Diagnostic Test: serum antimullerian hormone

Interventions

serum antimullerian hormone DIAGNOSTIC_TEST

serum antimullerian hormone will be analyzed for all participants

healthy participants; participants with epilepsy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

Location

Related Publications (11)

• 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.

  PMID: 21724534 BACKGROUND

• 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.

  PMID: 25585505 BACKGROUND

• 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.

  PMID: 16388003 BACKGROUND

• 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.

  PMID: 26753790 BACKGROUND

• 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.

  PMID: 18796535 BACKGROUND

• 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.

  PMID: 23237902 BACKGROUND

• 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.

  PMID: 12939416 BACKGROUND

• 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.

  PMID: 8162389 BACKGROUND

• 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.

  PMID: 14595652 BACKGROUND

• 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.

  PMID: 16981860 BACKGROUND

• 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.

  PMID: 27565413 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ALİ ÖZAY, Assoc Prof

  Near East University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Associate Professor

Model Details: two groups (epileptic and healthy participants)

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: October 4, 2021
• Study Start: July 2, 2021
• Primary Completion: February 20, 2022
• Study Completion: June 20, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)