AMH and Functional Hypothalamic Amenorrhea

NCT ID: NCT05921877

Last Updated: 2023-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-16

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Amenorrhea Secondary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

venous sampling

Intervention Type DIAGNOSTIC_TEST

venous sampling

Healthy controls

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

venous sampling

Intervention Type DIAGNOSTIC_TEST

venous sampling

Interventions

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venous sampling

venous sampling

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rosanna Apa

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Rosanna Apa, MD, PhD

Role: primary

00390630155872

Other Identifiers

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5321

Identifier Type: -

Identifier Source: org_study_id

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