Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2025
  • participants needed
    210
  • sponsor
    Tongji Hospital
Updated on 24 January 2021
gonadotropin
pituitary
testosterone
follicle stimulating hormone
testosterone level
hormone levels
menotropins
pituitary hormones
klinefelter syndrome
secondary hypogonadism
idiopathic hypogonadotropic hypogonadism
blood testosterone
serum fsh level

Summary

This study will evaluate the efficacy and safety of long term use of hCG alone or hCG plus hMG in the treatment of male patients with isolated hypogonadotropic hypogonadism (IHH). One third of the participants will receive hCG treatment alone and the other third of the participants will receive hCG treatment alone for six months, then the hMG will be added. And the last third of the participants will receive hCG and hMG treatment since the beginning of the treatment.

Description

The efficacy of hCG alone or hCG plus hMG in the treatment of male IHH patients was reported in some studies. However, these studies were mostly non-randomized controlled studies with small size of samples and short follow-up time. There was also no reported study which aimed to compare the efficacy and safety of long term use of hCG or hCG plus hMG in the treatment of male patients with IHH. So the difference in the efficacy and safety between long term use of hCG alone and hCG plus hMG in the treatment of IHH is unknown. In different reported studies, the hCG plus hMG treatment had two regimens: using hCG alone for six month, then hMG was added and using hCG plus hMG since the beginning of the treatment. The difference in the efficacy and safety between the above two regimes is also unknown.

Details
Condition Kallmann's Syndrome, Hypogonadism, Female Genital Diseases, Infertility, Gynecological Infections, Isolated Hypogonadotropic Hypogonadism, kallmann syndrome, sterility, unable to conceive
Treatment human menopausal gonadotropin, Human Chorionic Gonadotropin
Clinical Study IdentifierNCT03687606
SponsorTongji Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Are you male?
Do you have any of these conditions: Female Genital Diseases or Hypogonadism or Kallmann's Syndrome or Gynecological Infections or Isolated Hypogonadotropic Hypogonadism or Infertility?
Do you have any of these conditions: sterility or Infertility or Hypogonadism or kallmann syndrome or Female Genital Diseases or Isolated Hypogonadotropic Hypogonadism or Kallmann's Syndr...?
Age 18, 45 years old
Adolescent dysplasia or loss of puberty: Genital Tanner score 5, pubic hair Tanner score 5
Serum FSH and LH levels are low or in normal low value, testosterone was lower than normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology)
With or without olfactory loss/reduction
Other pituitary hormone levels are normal
Head MRI examination is normal
Fertility is desired currently or will be desired in the future
Understand and sign the informed consent form

Exclusion Criteria

Primary hypogonadism
Acquired hypogonadotrophic hypogonadism
A history of treatment with pulsed GnRH, hCG and FSH related hormones
Receive testosterone replacement therapy for more than 6 months
History of cryptorchidism or cryptorchidism
The sperm density before treatment 110^6/ml
Moderate or severe liver and kidney dysfunction (ALT>120IU/L, AST>80IU/L, CR>115mol/L)
The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes
True hermaphroditism and pseudohermaphroditism
Sex hormone abnormalities caused by adrenal lesions
Hypogonadism secondary to other systemic diseases
Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors)
There are other hormone abnormalities in the pituitary
There are contraindications for the treatment with hCG or hMG
Clear my responses

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