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

Primary Purpose

Idiopathic Hypogonadotropic Hypogonadism

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pulsatile Gonadotropin Releasing Hormone
Human chorionic gonadotropin
Urinary Follicle-Stimulating Hormone
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypogonadotropic Hypogonadism

Eligibility Criteria

16 Years - 35 Years (Child, Adult)MaleDoes not accept healthy volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pulsatile Gonadotropin Releasing Hormone

    combination gonadotropin therapy

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    pregnancy in the female partner

    Secondary Outcome Measures

    first appearance of sperm (month after treatment)
    first time with sperm density>1*10^6/ml（month after treatment）
    first time with sperm density>15*10^6/ml（month after treatment）

    Full Information

    First Posted
    December 3, 2014
    Last Updated
    January 31, 2015
    Sponsor
    Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02310074
    Brief Title
    Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
    Official Title
    Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Hypogonadotropic Hypogonadism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulsatile Gonadotropin Releasing Hormone
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    combination gonadotropin therapy
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Pulsatile Gonadotropin Releasing Hormone
    Other Intervention Name(s)
    Pulsatile GnRH pump
    Intervention Type
    Drug
    Intervention Name(s)
    Human chorionic gonadotropin
    Intervention Description
    Human chorionic gonadotropin (hCG)
    Intervention Type
    Drug
    Intervention Name(s)
    Urinary Follicle-Stimulating Hormone
    Intervention Description
    Urinary Follicle-Stimulating Hormone (uFSH)
    Primary Outcome Measure Information:
    Title
    pregnancy in the female partner
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    first appearance of sperm (month after treatment)
    Time Frame
    18 months
    Title
    first time with sperm density>1*10^6/ml（month after treatment）
    Time Frame
    18 months
    Title
    first time with sperm density>15*10^6/ml（month after treatment）
    Time Frame
    18 months
    Other Pre-specified Outcome Measures:
    Title
    testicular volume
    Time Frame
    18 months
    Title
    prostatic volume
    Time Frame
    18 months
    Title
    Tanner stage for pubic hair
    Time Frame
    18 months
    Title
    Tanner stage for genital
    Time Frame
    18 months
    Title
    serum hormone levels
    Description
    especially serum testosterone, LH, and FSH levels
    Time Frame
    18 months
    Title
    sperm concentration per ejaculate
    Time Frame
    18 months
    Title
    adverse events
    Time Frame
    18 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age greater than 16 yr Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism Hypogonadal serum testosterone levels (<166ng/dl) in the presence of low or normal gonadotropins Normal levels of other anterior pituitary hormones Normal MRI scans of the hypothalamo-pituitary region Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment Exclusion Criteria: With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study Congenital hypopituitarism Any medical or surgical conditions possibly affecting the experiment result Any clinically significant allergic diseases or allergic to the study drugs Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guang Ning, MD, PHD
    Organizational Affiliation
    Shanghai Jiao Tong University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31681165
    Citation
    Yang YY, Zheng SC, Wang WC, Yang ZW, Shan C, Zhang YW, Qi Y, Chen YH, Gu WQ, Wang WQ, Zhao HY, Liu JM, Sun SY. Osteocalcin Levels in Male Idiopathic Hypogonadotropic Hypogonadism: Relationship With the Testosterone Secretion and Metabolic Profiles. Front Endocrinol (Lausanne). 2019 Oct 11;10:687. doi: 10.3389/fendo.2019.00687. eCollection 2019.
    Results Reference
    derived

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

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