Clinical trial NCT02705014: Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
Official title: Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypogonadotropic Hypogonadism
Keywords: pituitary stalk interruption syndrome
pulsatile GnRH therapy
hypogonadotropic hypogonadism
hypopituitarism
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of serum Luteinizing Hormone(LH) value
timeFrame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
measure: Change of serum Follicle-Stimulating Hormone (FSH) value
timeFrame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
measure: Change of serum total testosterone value
timeFrame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Secondary outcomes:
measure: Change of testicular volume
timeFrame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment
measure: Change of sperm counts by routine semen analysis
timeFrame: Baseline and at 3m, 6m, 9m and 12m post treatment
measure: the rate of impregnating subject's wife
timeFrame: at 3m, 6m, 9m and 12m post treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xue-yan Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shao WM, Bai WJ, Chen YM, Liu L, Wang YJ. [Micropump infusion of gonadorelin in the treatment of hypogonadotropic hypogonadism in patients with pituitary stalk interruption syndrome: cases analysis and literature review]. Beijing Da Xue Xue Bao Yi Xue Ban. 2014 Aug 18;46(4):642-5. Chinese.
citation: Zheng J, Mao J, Xu H, Wang X, Huang B, Liu Z, Cui M, Xiong S, Ma W, Min L, Kaiser UB, Nie M, Wu X. Pulsatile GnRH Therapy May Restore Hypothalamus-Pituitary-Testis Axis Function in Patients With Congenital Combined Pituitary Hormone Deficiency: A Prospective, Self-Controlled Trial. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2291-2300. doi: 10.1210/jc.2016-3990.