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

Phase 4

• Conditions: Azoospermia; Oligospermia
• Interventions: Drug: 75IU uFSH

• Registration Number: NCT02307994
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-08
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
75IU uFSH	75IU uFSH	75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months

Primary Outcome Measures

Name	Time	Method
(A + B)grade sperm and sperm activity rate	6 month
A grade sperm	6 month
semen volume	6 month
sex hormone levels	6 month
testis volume	6 month
Sperm density	6 month

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China