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

Oligospermia Clinical Trial

Official title:

Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02307994
• Other study ID #: LIVZON-R-14-01
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: December 2, 2014
• Last updated: December 4, 2014
• Start date: August 2014

Study information

• Verified date: August 2014
• Source: Livzon Pharmaceutical Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia
• Oligospermia

Intervention

Drug:
• 75IU uFSH

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm density		6 month	No
Primary	(A + B)grade sperm and sperm activity rate		6 month	No
Primary	A grade sperm		6 month	No
Primary	semen volume		6 month	No
Primary	sex hormone levels		6 month	No
Primary	testis volume		6 month	No