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

Not Applicable

• Conditions: Hypogonadotropic Hypogonadism
• Interventions: Drug: Gonadotropin-releasing Hormone

• Registration Number: NCT02705014
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-22
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-06
• Last Update Submitted: 2016-03-06
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Primary Completion: 2016-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Gonadotropin-releasing Hormone	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.

Primary Outcome Measures

Name	Time	Method
Change of serum Luteinizing Hormone(LH) value	Baseline and at 1m,3m, 6m, 9m and 12m post treatment.	Luteinizing hormone (LH) is measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.24-8.62 IU/L. Initial efficacy is evaluated based on the values of serum LH and serum total testosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Change of serum Follicle-Stimulating Hormone (FSH) value	Baseline and at 1m,3m, 6m, 9m and 12m post treatment.	Follicle-stimulating hormone (FSH) are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.27-19.26 IU/L.
Change of serum total testosterone value	Baseline and at 1m,3m, 6m, 9m and 12m post treatment.	Total testosterone levels are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 175-781 ng/dL.Initial efficacy is evaluated based on the values of serum LH and serum totaltestosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.

Secondary Outcome Measures

Name	Time	Method
Change of testicular volume	Baseline and at 1m,3m, 6m, 9m and 12m post treatment	Testicular volumes are measured using Prader orchidometer. Prader orchidometer is a standard method to measure testicular volume. The normal range of testicular volume of each side in normal adult men is 15-25ml.
Change of sperm counts by routine semen analysis	Baseline and at 3m, 6m, 9m and 12m post treatment	if a subject can produce an ejaculate, semen samples are collected by masturbation and analyzed according to the standard World Health Organization method.
the rate of impregnating subject's wife	at 3m, 6m, 9m and 12m post treatment	For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China