AMELIA: AMH and Functional Hypothalamic Amenorrhea

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05921877
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 18.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amenorrhea Secondary	Diagnostic Test: venous sampling

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea
• Anticipated Study Start Date: Jun 16, 2023
• Anticipated Primary Completion Date: Jun 16, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. AMH assay [12 months]

   Check serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women.

Secondary Outcome Measures

1. To correlate AMH levels with other parameters [12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 34 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rosanna Apa	Rome		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05921877
• Other Study ID Numbers: 5321
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amenorrhea

Study Results

No Results Posted as of Jun 27, 2023