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Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307994
Recruitment Status : Unknown
Verified August 2014 by Livzon Pharmaceutical Group Inc..
Recruitment status was:  Enrolling by invitation
First Posted : December 4, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

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.

Condition or disease Intervention/treatment Phase
Oligospermia Azoospermia Drug: 75IU uFSH Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China
Study Start Date : August 2014
Estimated Primary Completion Date : June 2015

Arm Intervention/treatment
Experimental: 75IU uFSH
75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months
Drug: 75IU uFSH



Primary Outcome Measures :
  1. Sperm density [ Time Frame: 6 month ]
  2. (A + B)grade sperm and sperm activity rate [ Time Frame: 6 month ]
  3. A grade sperm [ Time Frame: 6 month ]
  4. semen volume [ Time Frame: 6 month ]
  5. sex hormone levels [ Time Frame: 6 month ]
  6. testis volume [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307994


Locations
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China
Peking University Third Hospital
Beijing, China, 100191
Sponsors and Collaborators
Livzon Pharmaceutical Group Inc.
Investigators
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Principal Investigator: Hui Jiang Peking University Third Hospital

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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT02307994    
Other Study ID Numbers: LIVZON-R-14-01
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: August 2014
Keywords provided by Livzon Pharmaceutical Group Inc.:
infertility
Additional relevant MeSH terms:
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Azoospermia
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male