Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Idiopathic Hypogonadotropic Hypogonadism

Treatments: Drug: Urinary Follicle-Stimulating Hormone; Drug: Human chorionic gonadotropin; Drug: Pulsatile Gonadotropin Releasing Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT02310074

ruijin-GnRH pump-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: Male

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Pulsatile Gonadotropin Releasing Hormone

Experimental group

Description:

Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months.

Treatment:

Drug: Pulsatile Gonadotropin Releasing Hormone

combination gonadotropin therapy

Active Comparator group

Description:

combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months

Treatment:

Drug: Urinary Follicle-Stimulating Hormone

Drug: Human chorionic gonadotropin