NCT02310074

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

February 3, 2015

Status Verified

December 1, 2014

Enrollment Period

4.4 years

First QC Date

December 3, 2014

Last Update Submit

January 31, 2015

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • pregnancy in the female partner

    18 months

Secondary Outcomes (3)

  • first appearance of sperm (month after treatment)

    18 months

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

    18 months

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

    18 months

Other Outcomes (7)

  • testicular volume

    18 months

  • prostatic volume

    18 months

  • Tanner stage for pubic hair

    18 months

  • +4 more other outcomes

Study Arms (2)

Pulsatile Gonadotropin Releasing Hormone

EXPERIMENTAL

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

combination gonadotropin therapy

ACTIVE COMPARATOR

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 gonadotropinDrug: Urinary Follicle-Stimulating Hormone

Interventions

Pulsatile Gonadotropin Releasing HormoneDRUG
Also known as: Pulsatile GnRH pump
Pulsatile Gonadotropin Releasing Hormone
Human chorionic gonadotropinDRUG

Human chorionic gonadotropin (hCG)

combination gonadotropin therapy
Urinary Follicle-Stimulating HormoneDRUG

Urinary Follicle-Stimulating Hormone (uFSH)

combination gonadotropin therapy

Eligibility Criteria

Age16 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31681165DERIVED

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

Chorionic GonadotropinUrofollitropin

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsMenotropinsGonadotropins, PituitaryPituitary Hormones, AnteriorPituitary Hormones

Study Officials

  • Guang Ning, MD, PHD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Last Updated

February 3, 2015

Record last verified: 2014-12