COMPLETED

Hormonal Regulation of Puberty and Fertility

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: \- The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels through the bloodstream to the pituitary gland, where it stimulates the gland to produce hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people, however, have either low levels or total lack of GnRH. This can cause problems with puberty and fertility. Researchers want to study people with low or no GnRH to better understand how it affects puberty and fertility. Objectives: \- To study disorders of GnRH production. Eligibility: * Adult men and women at least 18 years of age with low or no gonadotropin levels. * Adolescents between 14 and 18 years of age with low or no gonadotropin levels. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have tests to look at their hormone levels. Blood samples may be collected after taking different drugs, including insulin and cortisone. A 24-hour urine sample will be collected. * Participants will have imaging studies to look at bone and brain development. They will also have ultrasounds of the kidneys, abdomen, and reproductive organs. * Tests of smell and hearing will be used to look for abnormalities in these senses.

Official Title

The Role of Gonadotropin Pulsations in the Regulation of Puberty and Fertility

Quick Facts

Study Start:2012-04-25
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT01511588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low/normal gonadotropins; OR
  2. * Normal puberty with subsequent development of low gonadotropin levels.
  1. * Patients who have additional pituitary deficiencies, effectively ruling out isolated GnRH deficiency, whether these deficiencies are congenital or acquired (e.g. secondary to malignancy, infection, or irradiation).
  2. * Patients who are taking medications known to cause HH, such as corticosteroids or continuous opiate administration.
  3. * Pregnancy or lactation

Contacts and Locations

Principal Investigator

Natalie D Shaw, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
United States

Collaborators and Investigators

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

  • Natalie D Shaw, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Environmental Health Sciences (NIEHS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-04-25
Study Completion DateN/A

Study Record Updates

Study Start Date2012-04-25
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Kallmann Syndrome
  • Delayed Puberty
  • GnRH Deficiency
  • Infertility
  • Hypogonadotropic Hypogonadism
  • Natural History
  • Amenorrhea
  • Hypogonadism

Additional Relevant MeSH Terms

  • Endocrine Disease
  • Infertility
  • Hypogonadism
  • Amenorrhea
  • Adolescents