Back to resultsClinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
Primary Purpose
Oligospermia, Azoospermia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
75IU uFSH
Sponsored by
About this trial
This is an interventional treatment trial for Oligospermia focused on measuring infertility
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
75IU uFSH
Arm Description
75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months
Outcomes
Primary Outcome Measures
Sperm density
(A + B)grade sperm and sperm activity rate
A grade sperm
semen volume
sex hormone levels
testis volume
Secondary Outcome Measures
Full Information
NCT ID
NCT02307994
First Posted
December 2, 2014
Last Updated
December 4, 2014
Sponsor
Livzon Pharmaceutical Group Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02307994
Brief Title
Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
Official Title
Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Livzon Pharmaceutical Group Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligospermia, Azoospermia
Keywords
infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
75IU uFSH
Arm Type
Experimental
Arm Description
75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months
Intervention Type
Drug
Intervention Name(s)
75IU uFSH
Primary Outcome Measure Information:
Title
Sperm density
Time Frame
6 month
Title
(A + B)grade sperm and sperm activity rate
Time Frame
6 month
Title
A grade sperm
Time Frame
6 month
Title
semen volume
Time Frame
6 month
Title
sex hormone levels
Time Frame
6 month
Title
testis volume
Time Frame
6 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Jiang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
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