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

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ClinicalTrials.gov Identifier: NCT02310074
Recruitment Status : Unknown
Verified December 2014 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2014
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Hypogonadotropic Hypogonadism Drug: Pulsatile Gonadotropin Releasing Hormone Drug: Human chorionic gonadotropin Drug: Urinary Follicle-Stimulating Hormone Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Study Start Date : January 2010
Actual Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Pulsatile Gonadotropin Releasing Hormone
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.
Drug: Pulsatile Gonadotropin Releasing Hormone
Other Name: Pulsatile GnRH pump

Active Comparator: combination gonadotropin therapy
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
Drug: Human chorionic gonadotropin
Human chorionic gonadotropin (hCG)

Drug: Urinary Follicle-Stimulating Hormone
Urinary Follicle-Stimulating Hormone (uFSH)




Primary Outcome Measures :
  1. pregnancy in the female partner [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. first appearance of sperm (month after treatment) [ Time Frame: 18 months ]
  2. first time with sperm density>1*10^6/ml(month after treatment) [ Time Frame: 18 months ]
  3. first time with sperm density>15*10^6/ml(month after treatment) [ Time Frame: 18 months ]

Other Outcome Measures:
  1. testicular volume [ Time Frame: 18 months ]
  2. prostatic volume [ Time Frame: 18 months ]
  3. Tanner stage for pubic hair [ Time Frame: 18 months ]
  4. Tanner stage for genital [ Time Frame: 18 months ]
  5. serum hormone levels [ Time Frame: 18 months ]
    especially serum testosterone, LH, and FSH levels

  6. sperm concentration per ejaculate [ Time Frame: 18 months ]
  7. adverse events [ Time Frame: 18 months ]


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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310074


Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Guang Ning, MD, PHD Shanghai Jiao Tong University School of Medicine

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Responsible Party: Guang Ning, the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02310074     History of Changes
Other Study ID Numbers: ruijin-GnRH pump-002
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents