Analyzing AMH levels in women with functional hypothalamic amenorrhea
AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea
This study is trying to see how levels of a hormone called AMH change in young women who have been dealing with a condition that stops their periods for over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 15 Years to 34 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05921877 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze Anti-Müllerian Hormone (AMH) levels in women aged 15-34 who have been diagnosed with functional hypothalamic amenorrhea (FHA) for more than two years. The study hypothesizes that prolonged FHA may resemble primary hypogonadotropic hypogonadism due to a sustained interruption of gonadotropin release. After the resumption of the menstrual cycle, AMH levels will be reanalyzed to determine if they are higher, potentially challenging the notion that AMH is a reliable indicator of ovarian reserve in these patients. Participants will undergo venous sampling for AMH level assessment.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 15-34 with a diagnosis of functional hypothalamic amenorrhea lasting at least two years.
Not a fit: Patients with conditions such as polycystic ovary syndrome or those on oral contraceptives in the previous three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the reliability of AMH as a marker for ovarian reserve in women with functional hypothalamic amenorrhea.
How similar studies have performed: While this approach is based on previous studies, the specific analysis of AMH levels in prolonged FHA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome
- Rosanna Apa — Rome, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.