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

NCT03687606 | Unknown Phase 4

• 1 other identifier: TJ-IRB20180906
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Isolated Hypogonadotropic Hypogonadism; Kallmann Syndrome; Infertility

Keywords

Gonadotropin treatment; human chorionic gonadotropin; human menopausal gonadotropin

Outcome Measures

Primary Outcomes (1)

• Sperm density

  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.

  6 months.

Secondary Outcomes (8)

• Semen volume

  6 months.

• Sperm activity

  6 months.

• The time for sperm to appear during treatment

  6 months.

• Serum testosterone levels

  3 months.

• Testicular volume

  3 months.

Other Outcomes (3)

• Height

  3 months.

• Weight

  3 months.

• Feeling of inferiority scale score

  3 months.

Study Arms (3)

Human Chorionic Gonadotropin alone

ACTIVE COMPARATOR

Human Chorionic Gonadotropin 2000U\~6000U, intramuscular injection, two times per week for 3 years.

Drug: Human Chorionic Gonadotropin

hCG alone for 6 months then hMG added

EXPERIMENTAL

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; Drug: human menopausal gonadotropin

hCG and hMG

EXPERIMENTAL

Human Chorionic Gonadotropin 2000U\~6000U and 75\~150IU human menopausal gonadotropin, intramuscular injection, two times per week for 3 years.

Drug: Human Chorionic Gonadotropin; Drug: human menopausal gonadotropin

Interventions

Human Chorionic Gonadotropin DRUG

White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.

Also known as: hCG

Human Chorionic Gonadotropin alone; hCG alone for 6 months then hMG added; hCG and hMG

human menopausal gonadotropin DRUG

White freeze-dried cake or powder with specification of 75IU.

Also known as: hMG

hCG alone for 6 months then hMG added; hCG and hMG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 ≥1×10\^6/ml;
• Moderate or severe liver and kidney dysfunction (ALT\>120IU/L, AST\>80IU/L, CR\>115μmol/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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (2)

• Zacharin M, Sabin MA, Nair VV, Dabadghao P. Addition of recombinant follicle-stimulating hormone to human chorionic gonadotropin treatment in adolescents and young adults with hypogonadotropic hypogonadism promotes normal testicular growth and may promote early spermatogenesis. Fertil Steril. 2012 Oct;98(4):836-42. doi: 10.1016/j.fertnstert.2012.06.022. Epub 2012 Jul 3.

  PMID: 22763096 BACKGROUND

• Matsumoto AM, Snyder PJ, Bhasin S, Martin K, Weber T, Winters S, Spratt D, Brentzel J, O'Dea L. Stimulation of spermatogenesis with recombinant human follicle-stimulating hormone (follitropin alfa; GONAL-f): long-term treatment in azoospermic men with hypogonadotropic hypogonadism. Fertil Steril. 2009 Sep;92(3):979-990. doi: 10.1016/j.fertnstert.2008.07.1742. Epub 2008 Oct 18.

  PMID: 18930190 BACKGROUND

MeSH Terms

Conditions

Hypogonadism; Kallmann Syndrome; Infertility

Interventions

Chorionic Gonadotropin; Menotropins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Biological Products; Complex Mixtures

Study Officials

• Jihong Liu, M.D

  Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Xu, M.D

CONTACT

+86-15872427301; haoxutjmu@163.com

Yinwei Chen, M.D

CONTACT

+86-15527953877; 913904361@qq.com

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: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 27, 2018
• Study Start: October 18, 2018
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

CN (1)