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Trial record 69 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT03687606
Recruitment Status : Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Jihong Liu, Tongji Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Isolated Hypogonadotropic Hypogonadism Kallmann Syndrome Infertility Drug: Human Chorionic Gonadotropin Drug: human menopausal gonadotropin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in the Treatment of Male Patients With Isolated Hypogonadotropic Hypogonadism: an Open, Randomized Controlled Study
Estimated Study Start Date : September 25, 2018
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2025


Arm Intervention/treatment
Active Comparator: Human Chorionic Gonadotropin alone
Human Chorionic Gonadotropin 2000U~6000U, intramuscular injection, two times per week for 3 years.
Drug: Human Chorionic Gonadotropin
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
Other Name: hCG

Experimental: hCG alone for 6 months then hMG added
Human Chorionic Gonadotropin 2000U~6000U, intramuscular injection, two times per week for six months, then 75~150IU human menopausal gonadotropin, intramuscular injection, two times per week, was added and last for the next 30 months.
Drug: Human Chorionic Gonadotropin
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
Other Name: hCG

Drug: human menopausal gonadotropin
White freeze-dried cake or powder with specification of 75IU.
Other Name: hMG

Experimental: hCG and hMG
Human Chorionic Gonadotropin 2000U~6000U and 75~150IU human menopausal gonadotropin, intramuscular injection, two times per week for 3 years.
Drug: Human Chorionic Gonadotropin
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
Other Name: hCG

Drug: human menopausal gonadotropin
White freeze-dried cake or powder with specification of 75IU.
Other Name: hMG




Primary Outcome Measures :
  1. Sperm density [ Time Frame: 6 months. ]
    Sperm density will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.


Secondary Outcome Measures :
  1. Semen volume [ Time Frame: 6 months. ]
    Sperm volume will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.

  2. Sperm activity [ Time Frame: 6 months. ]
    Sperm activity will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.

  3. The time for sperm to appear during treatment [ Time Frame: 6 months. ]
    The time for the sperm firstly appeared in the semen will be recorded.

  4. Serum testosterone levels [ Time Frame: 3 months. ]
    The serum testosterone levels will be tested in every visit.

  5. Testicular volume [ Time Frame: 3 months. ]
    Testicular volume will be measured using a Prader orchidometer.

  6. Penis length [ Time Frame: 3 months. ]
    Penis length will be measured from the pubic symphysis to glans using a vernier caliper.

  7. Pubic hair [ Time Frame: 3 months. ]
    Pubic hair will be evaluated according to Tanner pubertal stages.

  8. Genitalia [ Time Frame: 3 months. ]
    Genitalia will be evaluated according to Tanner pubertal stages.


Other Outcome Measures:
  1. Height [ Time Frame: 3 months. ]
    Height will be measured at every visit.

  2. Weight [ Time Frame: 3 months. ]
    Weight will be measured at every visit.

  3. Feeling of inferiority scale score [ Time Frame: 3 months. ]
    Feeling of inferiority scale scores will be obtained using feeling of inferiority scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18, ≤ 45 years old;
  2. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner score ﹤ 5;
  3. 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);
  4. With or without olfactory loss/reduction;
  5. Other pituitary hormone levels are normal;
  6. Head MRI examination is normal;
  7. Fertility is desired currently or will be desired in the future;
  8. Understand and sign the informed consent form.

Exclusion Criteria:

  1. Primary hypogonadism;
  2. Acquired hypogonadotrophic hypogonadism;
  3. A history of treatment with pulsed GnRH, hCG and FSH related hormones;
  4. Receive testosterone replacement therapy for more than 6 months;
  5. History of cryptorchidism or cryptorchidism;
  6. The sperm density before treatment ≥1×10^6/ml;
  7. Moderate or severe liver and kidney dysfunction (ALT>120IU/L, AST>80IU/L, CR>115μmol/L);
  8. The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes;
  9. True hermaphroditism and pseudohermaphroditism;
  10. Sex hormone abnormalities caused by adrenal lesions;
  11. Hypogonadism secondary to other systemic diseases;
  12. Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors);
  13. There are other hormone abnormalities in the pituitary;
  14. There are contraindications for the treatment with hCG or hMG.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687606


Contacts
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Contact: Hao Xu, M.D +86-15872427301 haoxutjmu@163.com
Contact: Yinwei Chen, M.D +86-15527953877 913904361@qq.com

Sponsors and Collaborators
Tongji Hospital
Investigators
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Principal Investigator: Jihong Liu, M.D Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Publications:
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Responsible Party: Jihong Liu, Principal Investigator, Clinical Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03687606     History of Changes
Other Study ID Numbers: TJ-IRB20180906
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measure will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available with 6 months of study completion.
Access Criteria: Data access requests will be reviewed by the external independent review panel and Tongji hospital. Requester will be reqiured to sign a Data Acces Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jihong Liu, Tongji Hospital:
Gonadotropin treatment
human chorionic gonadotropin
human menopausal gonadotropin
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Infertility
Kallmann Syndrome
Hypogonadism
Genital Diseases, Male
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Menotropins
Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents