Idiopathic Hypogonadotropic Hypogonadism Clinical Trial
Official title:
Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex
development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy
and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we
compared the different efficacy and safety of pulsatile GnRH pump therapy with combination
gonadotropin therapy on fertility and sexual development in male patients with IHH.
The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints
were time to actual attainment of various sperm thresholds: sperm concentration>0*10^6/ml ,
>1.0 *10^6/ml and >15 *10^6/ml, respectively.
The clinical and laboratory characteristics including testicular and prostatic volume,
Tanner stage for pubic hair and genital, serum hormone levels [especially serum
testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels],
sperm concentration per ejaculate, and adverse events at baseline and at the end of
treatment were also evaluated.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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