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

NCT01165619 | Terminated

• 1 other identifier: 1200204347-BL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Hypogonadotropic Hypogonadism; Hypothalamic Amenorrhea

Outcome Measures

Primary Outcomes (1)

• Serum/plasma markers

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

  baseline

Secondary Outcomes (1)

• Genetics

  baseline

Study Arms (4)

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 Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, DNA

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 24, 2011

Record last verified: 2011-05

Locations

US (1)