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

ICSI AZOOSPERMIA VARICOCELE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306499
• Other study ID #: 729/2014
• Secondary ID: 729/259/2014
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2014
• Last updated: November 30, 2014
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Sohag University
• Contact: Mohamed Alhussini, M.B.B.Ch.
• Phone: 00201005817574
• Email: drhussini[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in a? ART program.

• ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele.

Exclusion Criteria:

• Cases with known female factor infertility

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia
• ICSI AZOOSPERMIA VARICOCELE
• Varicocele

Intervention

Procedure:
• ICSI
Intracytoplasmic Sperm Injection

Locations

Country	Name	City	State
Egypt	Ajyal Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.		6/2014 up to one year.	Yes
Secondary	Fertilization Rate: percentage of fertilized oocyte.		6/2014 up to one year.	Yes
Secondary	Embryo Quality: morphological assessment of the developing embryo.		6/2014 up to one year.	Yes
Secondary	Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.		6/2014 up to one year.	Yes