NCT01403532

Brief Summary

The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

February 1, 2011

Last Update Submit

February 10, 2014

Conditions

Hypogonadotropic HypogonadismKallmann Syndrome

Keywords

Hypogonadotropic HypogonadismKallmann SyndromeLHFSH

Outcome Measures

Primary Outcomes (1)

  • Sperm density ≥1,000,000/ml

    The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.

    One and a half year

Study Arms (3)

Traditional

ACTIVE COMPARATOR
Drug: Traditional intervention for HH using HCG and FSH

Sequential

EXPERIMENTAL
Drug: Sequential intervention for HH using HCG and FSH

Sequential Plus

EXPERIMENTAL
Drug: Sequential intervention for HH using HCG and FSH plus zinc

Interventions

Traditional intervention for HH using HCG and FSHDRUG

Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;

Also known as: Tranditional
Traditional
Sequential intervention for HH using HCG and FSHDRUG

Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months

Also known as: Sequential
Sequential
Sequential intervention for HH using HCG and FSH plus zincDRUG

Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily

Also known as: Sequential plus
Sequential Plus

Eligibility Criteria

Age16 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical hypogonadotropic hypogonadism
  • Hormonal levels: Testosterone \< 1.8ng/ml, LH \< 2-3 mIU/mL and FSH \< 2-3 mIU/mL
  • Infantile testis
  • Delayed bone age
  • Normal testing of the anterior pituitary gland

You may not qualify if:

  • Prior therapy with HMG or FSH
  • Severe dysfunction of live and kidney
  • Cryptorchidism or no response to HCG stimulation experiment (Testosterone \< 1.8ng/ml after HCG stimulation)
  • Another pituitary hormonal deficiency
  • Hypergonadotropic hypogonadism
  • With abnormal karyotype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.

    PMID: 25825944DERIVED

MeSH Terms

Conditions

HypogonadismKallmann Syndrome

Interventions

Zinc

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesDisorder of Sex Development, 46,XYDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Xiao-Ying Li, MD,PhD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2011

First Posted

July 27, 2011

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

CN(1)