Clinical Trial: Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia

Brief Summary: This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Detailed Summary:

Study approval: The study will be submitted for approval by Research and Ethical committees at Faculty of Medicine, Sohag University.

This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART program in Sohag .

Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Study design: Prospective, controlled clinical study. Control group: ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Cases with known female factor infertility will be excluded.

Outcome Measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.


Sponsor: Sohag University

Current Primary Outcome: Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment. [ Time Frame: 6/2014 up to one year. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fertilization Rate: percentage of fertilized oocyte. [ Time Frame: 6/2014 up to one year. ]
  • Embryo Quality: morphological assessment of the developing embryo. [ Time Frame: 6/2014 up to one year. ]
  • Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer. [ Time Frame: 6/2014 up to one year. ]


Original Secondary Outcome: Same as current

Information By: Sohag University

Dates:
Date Received: November 22, 2014
Date Started: June 2014
Date Completion: December 2015
Last Updated: November 30, 2014
Last Verified: November 2014