AMH and Functional Hypothalamic Amenorrhea (AMELIA)

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.

Study Overview

• Status: Recruiting
• Conditions: Amenorrhea Secondary
• Intervention / Treatment: Diagnostic test: venous sampling

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Rosanna Apa
    • Contact: Rosanna Apa, MD, PhD; Phone Number: 00390630155872; Email: rosanna.apa@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: venous sampling; venous sampling
Healthy controls; Women aged 15-34 years Normal menstrual cycles No interventions to be administered	Diagnostic test: venous sampling; venous sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH assay	Check serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): June 16, 2023
• Primary Completion (Estimated): June 16, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea
• Other Study ID Numbers: 5321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No