Clinical trial NCT02310074: Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Official title: Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Idiopathic Hypogonadotropic Hypogonadism
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 76
Sex: MALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: pregnancy in the female partner
timeFrame: 18 months
Secondary outcomes:
measure: first appearance of sperm (month after treatment)
timeFrame: 18 months
measure: first time with sperm density>1*10^6/ml（month after treatment）
timeFrame: 18 months
measure: first time with sperm density>15*10^6/ml（month after treatment）
timeFrame: 18 months
Other outcomes:
measure: testicular volume
timeFrame: 18 months
measure: prostatic volume
timeFrame: 18 months
measure: Tanner stage for pubic hair
timeFrame: 18 months
measure: Tanner stage for genital
timeFrame: 18 months
measure: serum hormone levels
timeFrame: 18 months
measure: sperm concentration per ejaculate
timeFrame: 18 months
measure: adverse events
timeFrame: 18 months
Locations:
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Guang Ning, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang YY, Zheng SC, Wang WC, Yang ZW, Shan C, Zhang YW, Qi Y, Chen YH, Gu WQ, Wang WQ, Zhao HY, Liu JM, Sun SY. Osteocalcin Levels in Male Idiopathic Hypogonadotropic Hypogonadism: Relationship With the Testosterone Secretion and Metabolic Profiles. Front Endocrinol (Lausanne). 2019 Oct 11;10:687. doi: 10.3389/fendo.2019.00687. eCollection 2019.