Amenorrhea SecondaryAMELIANCT05921877
AMH and Functional Hypothalamic Amenorrhea
An observational study of Amenorrhea Secondary, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Read more about this study
- Who is it for?
- Ages 15 to 34 years, women only
- Conditions the study is for
- Amenorrhea Secondary
- What is being tested?
- venous sampling
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2023to 31 Dec 2024
- How long will I take part?
- 2 Years
- 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 15 to 34 years
- Women only
- Child, Adult
Study population: Patients with functional hypotalamic amenorrhea (FHA) will be recruited from the DH of Dysfunctional Gynecology (UOSD Diagnostic and Medical Therapy of Menstrual Dysfunction and Marital Infertility) Department of Women's, Children's and Public Health Sciences of the A. Gemelli IRCCS University Polyclinic Foundation. Possible enrollment in the study protocol will not affect or alter in any way the patient's clinical course or adherence to good clinical practice guidelines. A group of healthy controls will also be enrolled, respecting the same exclusion criteria, from among the patients afferent to the Day Hospital of Dysfunctional Gynecology (healthy control is defined as: patient not suffering from functional hypothalamic amenorrhea, not from polycystic ovary syndrome and with 10-12 menstrual cycles per year).
Who may be able to join
- Women aged 15-34 years.
- Diagnosis of functional hypothalamic amenorrhea (for at least 2 years).
- Signature of informed consent.
Who cannot join
- Polycystic ovary syndrome
- Taking oral contraceptives in the previous three months
- Other clinically relevant endocrinopathies
- positive MAP-test (Medroxyprogesterone acetate test)
- Estroprogestin replacement therapy
- Autoimmune disorders
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rosanna Apa
Rome, 00168
Rosanna Apa, MD, PhD, 00390630155872, rosanna.apa@policlinicogemelli.it
About this study
Official title: AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea
The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.
- Conditions
- Amenorrhea Secondary
- Being tested
- venous sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous samplingDiagnostic test
venous sampling
| Study group | Role | What they receive |
|---|---|---|
| Patients with functional hypothalamic amenorrhea | Women aged 15-34 years Diagnosis of functional hypothalamic amenorrhea (for at least 2 years) No interventions to be administered Receives: Diagnostic Test: venous sampling | |
| Healthy controls | Women aged 15-34 years Normal menstrual cycles No interventions to be administered Receives: Diagnostic Test: venous sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH assay
Check serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women.
Measured: 12 months
Secondary outcomes (1)
To correlate AMH levels with other parameters
Correlate serologic AMH levels with antral follicle count (AFC). Verify serologic AMH levels in previously FHA patients after resumption of spontaneous menstruation, i.e., at 6 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start16 Jun 2023 (estimated)
- Primary completion16 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amenorrhea SecondaryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921877
- Sponsor's protocol ID
- 5321
- Acronym
- AMELIA
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea
- ClinicalTrials.gov ID
- NCT05921877
- Acronym / sponsor ID
- AMELIA / 5321
- Conditions
- Amenorrhea Secondary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Jun 2023 (estimated)
- Primary completion
- 16 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jun 2023 (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 purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with functional hypothalamic amenorrhea | – | Diagnostic Test: venous samplingWomen aged 15-34 years Diagnosis of functional hypothalamic amenorrhea (for at least 2 years) No interventions to be administered |
| Healthy controls | – | Diagnostic Test: venous samplingWomen aged 15-34 years Normal menstrual cycles No interventions to be administered |
Who may qualify
- Ages
- 15 to 34 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Patients with functional hypotalamic amenorrhea (FHA) will be recruited from the DH of Dysfunctional Gynecology (UOSD Diagnostic and Medical Therapy of Menstrual Dysfunction and Marital Infertility) Department of Women's, Children's and Public Health Sciences of the A. Gemelli IRCCS University Polyclinic Foundation. Possible enrollment in the study protocol will not affect or alter in any way the patient's clinical course or adherence to good clinical practice guidelines. A group of healthy controls will also be enrolled, respecting the same exclusion criteria, from among the patients afferent to the Day Hospital of Dysfunctional Gynecology (healthy control is defined as: patient not suffering from functional hypothalamic amenorrhea, not from polycystic ovary syndrome and with 10-12 menstrual cycles per year).
Key inclusion criteria (3 listed)
- Women aged 15-34 years.
- Diagnosis of functional hypothalamic amenorrhea (for at least 2 years).
- Signature of informed consent.
Key exclusion criteria (7 listed)
- Polycystic ovary syndrome
- Taking oral contraceptives in the previous three months
- Other clinically relevant endocrinopathies
- positive MAP-test (Medroxyprogesterone acetate test)
- Estroprogestin replacement therapy
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 |
|---|---|---|
| venous samplingvenous sampling | Diagnostic test | Healthy controls, Patients with functional hypothalamic amenorrhea |
Primary outcome
AMH assay
Time frame: 12 months
Check serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women.
1 secondary outcome
To correlate AMH levels with other parameters
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amenorrhea Secondary, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH assay (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2023.