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

March 6, 2016 updated by: wuxueyan, Peking Union Medical College Hospital
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
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.
Drug: Gonadotropin-releasing Hormone
A regimen of pulsatile GnRH (Fengyuan pharmaceutical company, Anhui province, China) administered subcutaneous via a portable infusion pump (Weichuang Medical Science Company, Shanghai city, China) at a 90-minute interval. The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L ( 200-500 ng/dL).
Other Names:
  • Gonadorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum Luteinizing Hormone(LH) value
Time Frame: 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.
Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Change of serum Follicle-Stimulating Hormone (FSH) value
Time Frame: 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.
Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Change of serum total testosterone value
Time Frame: 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.
Baseline and at 1m,3m, 6m, 9m and 12m post treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of testicular volume
Time Frame: 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.
Baseline and at 1m,3m, 6m, 9m and 12m post treatment
Change of sperm counts by routine semen analysis
Time Frame: 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.
Baseline and at 3m, 6m, 9m and 12m post treatment
the rate of impregnating subject's wife
Time Frame: at 3m, 6m, 9m and 12m post treatment
For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment.
at 3m, 6m, 9m and 12m post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Xue-yan Wu, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

March 6, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 6, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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