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Completed

NCT Number: NCT01403532

Sequential Therapy for Hypogonadotropic Hypogonadism

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.

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Key information

Conditions

Hypogonadotropic Hypogonadism Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorder of Sex Development, 46,XY Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Hypogonadism Kallmann Syndrome Male Urogenital Diseases Urogenital Abnormalities Urogenital Diseases

Age range

16 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Traditional intervention for HH using HCG and FSH

Drug

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;

Other names: Tranditional

Sequential intervention for HH using HCG and FSH

Drug

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

Other names: Sequential

Sequential intervention for HH using HCG and FSH plus zinc

Drug

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

Other names: Sequential plus

Primary outcomes

  1. Sperm density ≥1,000,000/ml

    Time frame: One and a half year

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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 27, 2011
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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