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

Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01165619

Enrollment

Registered

2010-07-20

Start date

2010-06-30

Completion date

2010-10-31

Last updated

2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothalamic Amenorrhea, Idiopathic Hypogonadotropic Hypogonadism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results