Text Size

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

This study has been terminated.
(the Principal Investigator left the institution)
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01165619
First received: July 16, 2010
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Idiopathic Hypogonadotropic Hypogonadism
Hypothalamic Amenorrhea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Serum/plasma markers [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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:
  • Genetics [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

serum, plasma, DNA


Enrollment: 50
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The reproductive disorder populations will be recruited from the reproductive endocrine clinic at the Mass General Hospital. The control populations will be recruited from Boston and surrounding communities

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165619

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Nelly Pitteloud, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01165619     History of Changes
Other Study ID Numbers: 1200204347-BL
Study First Received: July 16, 2010
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amenorrhea
Hypogonadism
Menstruation Disturbances
 Pathologic Processes
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013