Hypogonadism Clinical Trial
Official title:
Role of FSH in Human Gonadal Development
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.
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 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 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.
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