Trial · Interventional

Status unknownPhase 4Registry data

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

Short name IHH

NCTNCT03687606Other idTJ-IRB20180906

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 210 participants (estimated)
Sponsor: Tongji Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 18 Oct 2018
Primary completion: 1 Oct 2024 (estimated)
Completion: 1 Oct 2025 (estimated)
First posted: 27 Sept 2018
Last update posted: 8 Apr 2020
Conditions: Isolated Hypogonadotropic Hypogonadism · Kallmann Syndrome · Infertility

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

Ph 4
IHH
NCT03687606
18 Oct 2018 to est. 1 Oct 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Human Chorionic GonadotropinDrug
human menopausal gonadotropinDrug

Arms3

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Sperm density
Time frame · 6 months.
Registry description
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 outcomes(8)

Semen volume
Time frame · 6 months.
Registry description
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.
Sperm activity
Time frame · 6 months.
Registry description
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.
The time for sperm to appear during treatment
Time frame · 6 months.
Registry description
The time for the sperm firstly appeared in the semen will be recorded.
Serum testosterone levels
Time frame · 3 months.
Registry description
The serum testosterone levels will be tested in every visit.
Testicular volume
Time frame · 3 months.
Registry description
Testicular volume will be measured using a Prader orchidometer.
Penis length
Time frame · 3 months.
Registry description
Penis length will be measured from the pubic symphysis to glans using a vernier caliper.
Pubic hair
Time frame · 3 months.
Registry description
Pubic hair will be evaluated according to Tanner pubertal stages.
Genitalia
Time frame · 3 months.
Registry description
Genitalia will be evaluated according to Tanner pubertal stages.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2012

Corrected

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.

Zacharin et al. 2012Fertility and sterilitycited by 53

PMID 22763096DOI 10.1016/j.fertnstert.2012.06.022PUB-22763096

Full text at the publisher

Publisher page Read the notice

Indexing hint: Clinical trial · 2009

Stimulation of spermatogenesis with recombinant human follicle-stimulating hormone (follitropin alfa; GONAL-f): long-term treatment in azoospermic men with hypogonadotropic hypogonadism.

Matsumoto et al. 2009Fertility and sterilitycited by 42

PMID 18930190DOI 10.1016/j.fertnstert.2008.07.1742PUB-18930190

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.