Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders

NCT ID: NCT01165619

Last Updated: 2011-05-24

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

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-10-31

Brief Summary

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In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.

Detailed Description

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Conditions

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Idiopathic Hypogonadotropic Hypogonadism Hypothalamic Amenorrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hypothalamic Amenorrhea

This group is for pre-menopausal women between the aged 18-40 who have been previously diagnosed with Hypothalamic Amenorrhea. They can be currently diagnosed or may have recovered.

No interventions assigned to this group

Healthy Adult Men

This group is men over the age of 18 who do not have any history of reproductive disorders or chronic disease.

No interventions assigned to this group

Healthy Adult Women

This group is pre-menopausal, regularly menstruating women ages 18-40 who do not have a history of reproductive disorders or chronic disease.

No interventions assigned to this group

Idiopathic Hypogonadotropic Hypogonadism

This group is for adult men and women over the age of 18 who have been diagnosed with Idiopathic Hypogonadotropic Hypogonadism with or without anosmia.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Over the age of 18 for men
* Between the ages of 18 and 40 for women
* For reproductive disorder population: Current or previous diagnosis of Idiopathic Hypogonadotropic Hypogonadism or Hypothalamic Amenorrhea

Exclusion Criteria

* chronic disease (hypertension, high cholesterol, diabetes, asthma, etc)
* polycystic ovarian syndrome for women
* prescription medication use (other than allergy meds) for control populations
* irregular menstrual cycles for healthy female control population (cycle length longer than 35 days or shorter than 25 days. cycle length varies by more than 5 days. less than 9 periods per year)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1200204347-BL

Identifier Type: -

Identifier Source: org_study_id

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