|
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism Clinical research trials and Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism. Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism clinical trial. Human subjects frequently get the finest healthcare available for their Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism  Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism
For Condition: Kallmann Syndrome,Hypogonadism
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small testicular size, low testosterone levels, no history of puberty, and infertility. These men lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development and maturation of the testes. This study will investigate the impact of hormonal treatments on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these individuals.
Details: Though steroid output of the testes is minimal during childhood, important changes take place that impact spermatogenic potential. Specifically, the number of Sertoli cells increases until testosterone secretion rises during puberty. In animal models, the proliferation of Sertoli cells appears to be regulated by follicle stimulating hormone (FSH) even though FSH levels in childhood are relatively low. At puberty, the number of Sertoli cells becomes fixed; however, the existing cell population then undergoes functional maturation. This switch from proliferation to maturation of Sertoli cells appears to result from rising levels of intratesticular testosterone. FSH deficiency during testicular development results in decreased numbers of Sertoli cells, even if physiologic hormonal replacement therapy is introduced in adolescence or adulthood. The number of mature Sertoli cells appears to correlate with testicular size, sperm count, and future fertility. An improved understanding of the specific roles of FSH, luteinizing hormone (LH), and testosterone in testicular development may have direct clinical applications in the treatment of male infertility. This study will define the role of FSH in stimulating Sertoli cell proliferation in the human male. Patients in this study will be randomized to receive either FSH and GnRH (Group 1) or GnRH alone (Group 2). Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of > 8.4 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will receive the same regimen of exogenous GnRH for 18 months without prior FSH administration. All patients will undergo an initial assessment that includes an overnight 12-hour frequent blood sampling study, testicular ultrasound, and testicular biopsy. Patients will be followed through monthly study visits with blood tests and seminal fluid analysis. Patients will have testicular ultrasounds at Months 4, 12, and 18. Patients in Group 1 will also have a second frequent blood sampling to measure LH, FSH, and testosterone and to confirm the absence of LH pulses.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria - Complete absence of normal LH pulses during 12-hour baseline frequent blood sampling - Serum testosterone < 100 ng/dl - Inhibin B level < 60 pg/dl - Normal testing of the anterior pituitary gland - Negative MRI of the hypothalamic-pituitary area - Androgen replacement therapy discontinued to provide a sufficient washout period prior to the frequent blood sampling study Exclusion Criteria - History of cryptorchidism - Prior therapy with gonadotropins or GnRH
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
WilliamCrowley, Principal Investigator, Massachusetts General Hospital/Harvard Medical School
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Nelly Pitteloud 617-724-1830
Additional Information:
Study ID Numbers: 2R01HD15788; 2 RO1 HD15788-17A
Study Start Date: April 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064987
Other Hypogonadism Studies:
1. Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism
Related Studies:
Other Hypogonadism Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism
|
|
|
|
|
|
|
|
