EpilepsyNCT05066360
Serum Antimullerian Hormone Levels Among Epileptic Patients
A study testing serum antimullerian hormone in people with Epilepsy and Reproductive Issues, run by Near East University, Turkey at 1 site in Cyprus.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Reproductive Issues
- What is being tested?
- serum antimullerian hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 2 Jul 2021to 20 Jun 2023
- Phase
- Interventional
- 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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy and epileptic volunteer females
- Ages between 12-18
- After menarche
Who cannot join
- ovarian surgery,
- history of radiotherapy
- history of chemotherapy,
- before menarche
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Serum Antimullerian Hormone Levels in Adolescent Epilepsy Patients
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
- Being tested
- serum antimullerian hormone
- Keywords
- anti-mullerian hormone, epilepsy, adolescent
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum antimullerian hormoneDiagnostic test
serum antimullerian hormone will be analyzed for all participants
| Study group | Role | What they receive |
|---|---|---|
| participants with epilepsy | Other | healthy, menstruating females between 12-18 ages Receives: Diagnostic Test: serum antimullerian hormone |
| healthy participants | Other | epileptic, menstruating females between 12-18 ages Receives: Diagnostic Test: serum antimullerian hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum anti-mullerian hormone levels
The comparison of serum levels of anti-mullerian hormone between epileptic and healthy groups
Measured: baseline, at the time of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start2 Jul 2021
- Primary completion20 Feb 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups (epileptic and healthy participants)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Cenk, Near East University, Turkey
- Investigators
- ALİ ÖZAY, Assoc Prof, Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066360
- Sponsor's protocol ID
- AMH
- Status last verified
- Jan 2024
- First submitted
- 2 Jul 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Serum antimullerian hormone levels will be shared for both groups
Publications
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.
PubMed 21724534Practice 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 25585505Visser 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.
PubMed 16388003Cimino 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.
PubMed 26753790Lebeurrier 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.
PubMed 18796535Harden 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.
PubMed 23237902Harden 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.
PubMed 12939416Meo 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.
PubMed 8162389Herzog 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.
PubMed 14595652Quigg 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.
PubMed 16981860Harden 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.
PubMed 27565413
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Serum Antimullerian Hormone Levels in Adolescent Epilepsy Patients
- ClinicalTrials.gov ID
- NCT05066360
- Acronym / sponsor ID
- AMH
- Conditions
- Epilepsy, Reproductive Issues
- Keywords
- anti-mullerian hormone, epilepsy, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups (epileptic and healthy participants)
| Arm | Type | Receives |
|---|---|---|
| participants with epilepsy | Other | Diagnostic Test: serum antimullerian hormonehealthy, menstruating females between 12-18 ages |
| healthy participants | Other | Diagnostic Test: serum antimullerian hormoneepileptic, menstruating females between 12-18 ages |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy and epileptic volunteer females
- Ages between 12-18
- After menarche
Key exclusion criteria (4 listed)
- ovarian surgery,
- history of radiotherapy
- history of chemotherapy,
- before menarche
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum antimullerian hormoneserum antimullerian hormone will be analyzed for all participants | Diagnostic test | healthy participants, participants with epilepsy |
Primary outcome
serum anti-mullerian hormone levels
Time frame: baseline, at the time of examination
The comparison of serum levels of anti-mullerian hormone between epileptic and healthy groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 21724534Karkanaki 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.
- Background: PubMed 25585505Practice 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.
- Background: PubMed 16388003Visser 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.
- Background: PubMed 26753790Cimino 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.
- Background: PubMed 18796535Lebeurrier 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.
- Background: PubMed 23237902Harden 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.
- Background: PubMed 12939416Harden 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.
- Background: PubMed 8162389Meo 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.
- Background: PubMed 14595652Herzog 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.
- Background: PubMed 16981860Quigg 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.
- Background: PubMed 27565413Harden 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.
- Individual participant dataSharing planned: No. Serum antimullerian hormone levels will be shared for both groups
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALİ ÖZAY, Assoc Prof principal investigator
Near East University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum antimullerian hormone in people with Epilepsy and Reproductive Issues, run by Near East University, Turkey at 1 site in Cyprus.
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 4 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 29 Jan 2024. 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 Cyprus. 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 anti-mullerian hormone levels (time frame: baseline, at the time of examination). 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 NCT05066360, which also lists 11 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 29 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.