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AMH and Functional Hypothalamic Amenorrhea

AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05921877
Acronym
AMELIA
Enrollment
50
Registered
2023-06-27
Start date
2023-06-16
Completion date
2024-12-31
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea Secondary

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTvenous sampling

venous sampling

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 34 Years

Inclusion criteria

* Women aged 15-34 years. * Diagnosis of functional hypothalamic amenorrhea (for at least 2 years). * Signature of informed consent.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
AMH assay12 monthsCheck serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women.

Secondary

MeasureTime frameDescription
To correlate AMH levels with other parameters12 monthsCorrelate 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026