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

Not Applicable

• Conditions: ICSI AZOOSPERMIA VARICOCELE
• Interventions: Procedure: ICSI

• Registration Number: NCT02306499
• Lead Sponsor: Sohag University

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 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.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-11
• Study First Submitted: 2014-11-22
• Study First Submitted QC: 2014-11-30
• Last Update Submitted: 2014-11-30
• Study First Posted: 2014-12-03
• Last Update Posted: 2014-12-03
• Primary Completion: 2015-05
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE	ICSI	ICSI cases using cryopreserved testicular sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program
ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE	ICSI	ICSI cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.	6/2014 up to one year.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ajyal Hospital; 🇪🇬 Sohag, Egypt