AMH and Functional Hypothalamic Amenorrhea (AMELIA)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Amenorrhea Secondary

Treatments: Diagnostic Test: venous sampling

Study type: Observational

Funder types: Other

Identifiers

NCT05921877

5321

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 15 to 34 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Patients with functional hypothalamic amenorrhea

Description:

Women aged 15-34 years Diagnosis of functional hypothalamic amenorrhea (for at least 2 years) No interventions to be administered

Treatment:

Diagnostic Test: venous sampling

Healthy controls

Description:

Women aged 15-34 years Normal menstrual cycles No interventions to be administered

Treatment:

Diagnostic Test: venous sampling