NCT02307994

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

December 8, 2014

Status Verified

August 1, 2014

Enrollment Period

10 months

First QC Date

December 2, 2014

Last Update Submit

December 4, 2014

Conditions

OligospermiaAzoospermia

Keywords

infertility

Outcome Measures

Primary Outcomes (6)

  • Sperm density

    6 month

  • (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

Study Arms (1)

75IU uFSH

EXPERIMENTAL

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

Interventions

75IU uFSHDRUG
75IU uFSH

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 were IHH patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

OligospermiaAzoospermiaInfertility

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Hui Jiang

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Last Updated

December 8, 2014

Record last verified: 2014-08

Locations

CN(1)