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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02307994
Enrollment
180
Registered
2014-12-04
Start date
2014-08-31
Completion date
Unknown
Last updated
2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azoospermia, Oligospermia

Keywords

infertility

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.

Interventions

DRUG75IU uFSH

Sponsors

Livzon Pharmaceutical Group Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frame
Sperm density6 month
(A + B)grade sperm and sperm activity rate6 month
A grade sperm6 month
semen volume6 month
sex hormone levels6 month
testis volume6 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026