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

November 30, 2014 updated by: Mohamed Al-Hussini Jad Abdel-latif, M.B.B.Ch., 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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Ajyal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE
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
Procedure: ICSI
Intracytoplasmic Sperm Injection
Experimental: ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE
ICSI cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele
Procedure: ICSI
Intracytoplasmic Sperm Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
6/2014 up to one year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Fertilization Rate: percentage of fertilized oocyte.
Time Frame: 6/2014 up to one year.
6/2014 up to one year.
Embryo Quality: morphological assessment of the developing embryo.
Time Frame: 6/2014 up to one year.
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.
6/2014 up to one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Reham Ezz-Eldawla, MD, Sohag University
  • Study Director: Mohamed Yahya, MD, Sohag University
  • Study Director: Muhammed Fawzy, Ibn Sina Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 22, 2014

First Submitted That Met QC Criteria

November 30, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

November 30, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 729/2014
  • 729/259/2014 (Other Identifier: Sohag University - Faculty of Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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