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

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Mass General Brigham

Status

Terminated

Conditions

Hypothalamic Amenorrhea
Idiopathic Hypogonadotropic Hypogonadism

Study type

Observational

Funder types

Other

Identifiers

NCT01165619
1200204347-BL

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

50 participants in 4 patient groups

Hypothalamic Amenorrhea
Description:
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
Description:
This group is men over the age of 18 who do not have any history of reproductive disorders or chronic disease.
Healthy Adult Women
Description:
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
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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