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

Sponsor
Livzon Pharmaceutical Group Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02307994
Collaborator
(none)
180
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 75IU uFSH
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sperm density [6 month]

  2. (A + B)grade sperm and sperm activity rate [6 month]

  3. A grade sperm [6 month]

  4. semen volume [6 month]

  5. sex hormone levels [6 month]

  6. testis volume [6 month]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing China 100191

Sponsors and Collaborators

  • Livzon Pharmaceutical Group Inc.

Investigators

  • Principal Investigator: Hui Jiang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier:
NCT02307994
Other Study ID Numbers:
  • LIVZON-R-14-01
First Posted:
Dec 4, 2014
Last Update Posted:
Dec 8, 2014
Last Verified:
Aug 1, 2014
Keywords provided by Livzon Pharmaceutical Group Inc.
infertility
Additional relevant MeSH terms:
Azoospermia
Oligospermia

Study Results

No Results Posted as of Dec 8, 2014