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

Livzon Pharmaceutical Group

Status and phase

Unknown

Phase 4

Conditions

Oligospermia

Azoospermia

Treatments

Drug: 75IU uFSH

Study type

Interventional

Funder types

Industry

Identifiers

NCT02307994

LIVZON-R-14-01

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Male

Ages

25 to 35 years old

Volunteers

No Healthy Volunteers

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