Idiopathic Hypogonadotropic Hypogonadism
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPulsatile Gonadotropin Releasing Hormone
DRUGHuman chorionic gonadotropin
Human chorionic gonadotropin (hCG)
Urinary Follicle-Stimulating Hormone (uFSH)
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Age greater than 16 yr 2. Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism 3. Hypogonadal serum testosterone levels (\<166ng/dl) in the presence of low or normal gonadotropins 4. Normal levels of other anterior pituitary hormones 5. Normal MRI scans of the hypothalamo-pituitary region 6. Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment
Exclusion criteria
1. With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study 2. Congenital hypopituitarism 3. Any medical or surgical conditions possibly affecting the experiment result 4. Any clinically significant allergic diseases or allergic to the study drugs 5. Recently drug or alcohol abuse(\>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pregnancy in the female partner | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| first appearance of sperm (month after treatment) | 18 months |
| first time with sperm density>1*10^6/ml（month after treatment） | 18 months |
| first time with sperm density>15*10^6/ml（month after treatment） | 18 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| serum hormone levels | 18 months | especially serum testosterone, LH, and FSH levels |
| testicular volume | 18 months | — |
| adverse events | 18 months | — |
| sperm concentration per ejaculate | 18 months | — |
| prostatic volume | 18 months | — |
| Tanner stage for pubic hair | 18 months | — |
| Tanner stage for genital | 18 months | — |
Outcome results
None listed