Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Hypogonadotropic Hypogonadism

Treatments: Drug: Gonadotropin-releasing Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT02705014

ZS-997

Details and patient eligibility

About

To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.

Full description

To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or over male patients;
• Absent or incomplete puberty development;
• Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations.
• at least two or more pituitary hormone deficiencies
• Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.

Exclusion criteria

• cryptorchidism history
• other causes of hypopituitarism or severe systemic disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment group

Experimental group

Description:

patients were administered with pulsatile gonadotropin-releasing hormone (GnRH )therapy for 12 months at an interval of 90 minutes.The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L.

Treatment:

Drug: Gonadotropin-releasing Hormone