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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-E-0050

Sponsoring Institute

National Institute of Environmental Health Sciences (NIEHS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 14 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Kallmann Syndrome;
Delayed Puberty;
GnRH Deficiency;
Infertility;
Hypogonadotropic Hypogonadism;
Natural History

Recruitment Keyword(s)

Delayed Puberty;
Infertility;
Amenorrhea;
Hypogonadism

Condition(s)

Endocrine Disease;
Infertility;
Hypogonadism;
Amenorrhea;
Adolescents

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Environmental Health Sciences

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.

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Eligibility

INCLUSION CRITERIA:

Since hypogonadotropic hypogonadism is a rare condition, with an incidence of 1/10,000 to 1/86,000 for isolated GnRH deficiency (34, 35), this protocol remains open to enrollment so that we may study all subjects that are both qualified and interested in participating.

Males or females who are greater than or equal to 14 years old with clinical findings of HH as outlined above will be included. In certain circumstances, a patient under the age of 14 years may be considered for baseline evaluation if there is sufficient evidence suggestive of HH, such as any two of the following: anosmia, history of cryptorchidism or microphallus.

EXCLUSION CRITERIA:

-Because HH represents a spectrum, where associated clinical findings may provide phenotypic clues to the assessment of inheritability and underlying physiology, exclusion criteria are very limited:

--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).

--Patients who are taking medications known to cause HH, such as corticosteroids or continuous opiate administration.

--Pregnancy or lactation


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Citations:

Belchetz PE, Plant TM, Nakai Y, Keogh EJ, Knobil E. Hypophysial responses to continuous and intermittent delivery of hypopthalamic gonadotropin-releasing hormone. Science. 1978 Nov 10;202(4368):631-3.

Seminara SB, Hayes FJ, Crowley WF Jr. Gonadotropin-releasing hormone deficiency in the human (idiopathic hypogonadotropic hypogonadism and Kallmann's syndrome): pathophysiological and genetic considerations. Endocr Rev. 1998 Oct;19(5):521-39.

Nachtigall LB, Boepple PA, Pralong FP, Crowley WF Jr. Adult-onset idiopathic hypogonadotropic hypogonadism--a treatable form of male infertility. N Engl J Med. 1997 Feb 6;336(6):410-5.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Janet E. Hall, M.D.
National Institute of Environmental Health Sciences (NIEHS)
RTP 101 DAVID P RALL BUILDING BG RM A222
111 TW ALEXANDER DR
DURHAM NC 27709
(984) 287-3647
janet.hall@nih.gov

NIEHS Join A Study Recruitment Group
National Institute of Environmental Health Sciences (NIEHS)

(855) 696-4347
myniehs@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01511588

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