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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01165619
Collaborator
(none)
50
Enrollment
1
Location
4
Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders
    Study Start Date :
    Jun 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    Healthy Adult Men

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

    Outcome Measures

    Primary Outcome Measures

    1. Serum/plasma markers [baseline]

      At the study visit, serum and plasma samples will be taken to measure levels of reproductive hormones and metabolic markers in the subjects' blood.

    Secondary Outcome Measures

    1. Genetics [baseline]

      At the study visit, blood will be taken and DNA cell lines will be made to screen for genes that potentially contribute to the development of reproductive disorders

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01165619
    Other Study ID Numbers:
    • 1200204347-BL
    First Posted:
    Jul 20, 2010
    Last Update Posted:
    May 24, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Hypogonadism
    Amenorrhea

    Study Results

    No Results Posted as of May 24, 2011