OligospermiaPhase 4NCT02307994
Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
A Phase 4 study testing 75IU uFSH in people with Oligospermia and Azoospermia, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men only
- Conditions the study is for
- Oligospermia, Azoospermia
- What is being tested?
- 75IU uFSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jun 2015
- 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 25 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects aged 20~35.
- They accorded with diagnostic criteria of severe oligospermia or azoospermia.
- They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.
Who cannot join
- Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.
- Subjects addicted to drug，tobacco，or alcohol.
- Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.
- Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .
- Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.
- Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for infertility .
- Subjects did not meet the inclusion criteria, did not according to the prescribed medication, were unable to judge the efficacy ,had incomplete information, or affected the efficacy or safety judgment.
- Subjects were IHH patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China
The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.
- Conditions
- Oligospermia, Azoospermia
- Being tested
- 75IU uFSH
- Keywords
- infertility
- Medical subject headings
- Oligospermia, Azoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75IU uFSHDrug
| Study group | Role | What they receive |
|---|---|---|
| 75IU uFSH | Experimental | 75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months Receives: Drug: 75IU uFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm density
Measured: 6 month
(A + B)grade sperm and sperm activity rate
Measured: 6 month
A grade sperm
Measured: 6 month
semen volume
Measured: 6 month
sex hormone levels
Measured: 6 month
testis volume
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligospermiaStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hui Jiang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307994
- Sponsor's protocol ID
- LIVZON-R-14-01
- Status last verified
- Aug 2014
- First submitted
- 2 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China
- ClinicalTrials.gov ID
- NCT02307994
- Acronym / sponsor ID
- LIVZON-R-14-01
- Conditions
- Oligospermia, Azoospermia
- Keywords
- infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- 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.
The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 75IU uFSH | Experimental | Drug: 75IU uFSH75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects aged 20~35.
- They accorded with diagnostic criteria of severe oligospermia or azoospermia.
- They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.
Key exclusion criteria (8 listed)
- Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.
- Subjects addicted to drug，tobacco，or alcohol.
- Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.
- Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .
- Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.
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 |
|---|---|---|
| 75IU uFSH | Drug | 75IU uFSH |
Primary outcome
Sperm density
Time frame: 6 month
(A + B)grade sperm and sperm activity rate
Time frame: 6 month
A grade sperm
Time frame: 6 month
semen volume
Time frame: 6 month
sex hormone levels
Time frame: 6 month
testis volume
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Hui Jiang principal investigator
Peking University Third Hospital
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 75IU uFSH in people with Oligospermia and Azoospermia, run by Livzon Pharmaceutical Group Inc. 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 3 inclusion and 8 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 Dec 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm density (time frame: 6 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2014.