Isolated Hypogonadotropic HypogonadismPhase 4IHHNCT03687606
Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)
A Phase 4 study testing Human Chorionic Gonadotropin and human menopausal gonadotropin in people with Isolated Hypogonadotropic Hypogonadism and Kallmann Syndrome, run by Tongji Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Isolated Hypogonadotropic Hypogonadism, Kallmann Syndrome, Infertility
- What is being tested?
- Human Chorionic Gonadotropin and human menopausal gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2018to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hao Xu, M.D, +86-15872427301
About this study
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
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.
Read the 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.
- Being tested
- Human Chorionic Gonadotropin, human menopausal gonadotropin
- Keywords
- Gonadotropin treatment, human chorionic gonadotropin, human menopausal gonadotropin
- Medical subject headings
- Hypogonadism, Kallmann Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Chorionic GonadotropinDrug
Also called hCG
White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
human menopausal gonadotropinDrug
Also called hMG
White freeze-dried cake or powder with specification of 75IU.
| Study group | Role | What they receive |
|---|---|---|
| Human Chorionic Gonadotropin alone | Active comparator | Human Chorionic Gonadotropin 2000U~6000U, intramuscular injection, two times per week for 3 years. Receives: 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. Receives: 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. Receives: Drug: Human Chorionic Gonadotropin; Drug: human menopausal gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months.
Secondary outcomes (8)
Semen volume
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.
Measured: 6 months.
Sperm activity
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.
Measured: 6 months.
The time for sperm to appear during treatment
The time for the sperm firstly appeared in the semen will be recorded.
Measured: 6 months.
Serum testosterone levels
The serum testosterone levels will be tested in every visit.
Measured: 3 months.
Testicular volume
Testicular volume will be measured using a Prader orchidometer.
Measured: 3 months.
Penis length
Penis length will be measured from the pubic symphysis to glans using a vernier caliper.
Measured: 3 months.
Pubic hair
Pubic hair will be evaluated according to Tanner pubertal stages.
Measured: 3 months.
Genitalia
Genitalia will be evaluated according to Tanner pubertal stages.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start18 Oct 2018
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Isolated Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Tongji Hospital
- Investigators
- Jihong Liu, M.D, Principal investigator, Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687606
- Sponsor's protocol ID
- TJ-IRB20180906
- Acronym
- IHH
- Status last verified
- Apr 2020
- First submitted
- 16 Sep 2018
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measure will be available.
Publications
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.
PubMed 22763096Matsumoto 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.
PubMed 18930190
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03687606
- Acronym / sponsor ID
- IHH / TJ-IRB20180906
- Keywords
- Gonadotropin treatment, human chorionic gonadotropin, human menopausal gonadotropin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Human Chorionic Gonadotropin alone | Active comparator | Drug: Human Chorionic GonadotropinHuman Chorionic Gonadotropin 2000U~6000U, intramuscular injection, two times per week for 3 years. |
| hCG alone for 6 months then hMG added | Experimental | Drug: Human Chorionic Gonadotropin, Drug: human menopausal gonadotropinHuman 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. |
| hCG and hMG | Experimental | Drug: Human Chorionic Gonadotropin, Drug: human menopausal gonadotropinHuman Chorionic Gonadotropin 2000U~6000U and 75~150IU human menopausal gonadotropin, intramuscular injection, two times per week for 3 years. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Chorionic GonadotropinAlso: hCGWhite freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U. | Drug | Human Chorionic Gonadotropin alone, hCG alone for 6 months then hMG added, hCG and hMG |
| human menopausal gonadotropinAlso: hMGWhite freeze-dried cake or powder with specification of 75IU. | Drug | hCG alone for 6 months then hMG added, hCG and hMG |
Primary outcome
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.
8 secondary outcomes
Semen volume
Time frame: 6 months.
Sperm activity
Time frame: 6 months.
The time for sperm to appear during treatment
Time frame: 6 months.
Serum testosterone levels
Time frame: 3 months.
Testicular volume
Time frame: 3 months.
Penis length
Time frame: 3 months.
Pubic hair
Time frame: 3 months.
Genitalia
Time frame: 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Background: PubMed 22763096Zacharin 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.
- Background: PubMed 18930190Matsumoto 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihong Liu, M.D principal investigator
Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Chorionic Gonadotropin and human menopausal gonadotropin in people with Isolated Hypogonadotropic Hypogonadism and Kallmann Syndrome, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Xu, M.D (+86-15872427301, haoxutjmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm density (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687606, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.