Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064987
Status:
TERMINATED
Last Update Posted:
2017-07-07
First Post:
2003-07-16
Brief Title:
Follicle Stimulating Hormone FSH to Improve Testicular Development in Men With Hypogonadism
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Role of FSH in Human Gonadal Development
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was at a standstill We are currently preparing our results for publication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 4-8 IUL 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 also have serial testicular ultrasounds to measure testicular growth 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
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 4-8 IUL 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 also have serial testicular ultrasounds to measure testicular growth 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54HD028138 | NIH | None | httpsreporternihgovquickSearchU54HD028138 |