AMH and Functional Hypothalamic Amenorrhea

NCT05921877 | Unknown DMC

• 1 other identifier: 5321
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amenorrhea Secondary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To correlate AMH levels with other parameters

  12 months

Study Arms (2)

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

Healthy controls

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

Diagnostic Test: venous sampling

Interventions

venous sampling DIAGNOSTIC_TEST

venous sampling

Healthy controls; Patients with functional hypothalamic amenorrhea

Eligibility Criteria

• Age: 15 Years - 34 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Rosanna Apa

Rome, 00168, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: June 16, 2023
• Primary Completion: June 16, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)