AMH and Functional Hypothalamic Amenorrhea

Recruiting

• Conditions: Amenorrhea Secondary
• Interventions: Diagnostic Test: venous sampling

• Registration Number: NCT05921877
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-16
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-06-16
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with functional hypothalamic amenorrhea	venous sampling	Women aged 15-34 years Diagnosis of functional hypothalamic amenorrhea (for at least 2 years) No interventions to be administered
Healthy controls	venous sampling	Women aged 15-34 years Normal menstrual cycles No interventions to be administered

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Rosanna Apa; 🇮🇹 Rome, Italy