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

Primary Purpose

ICSI AZOOSPERMIA VARICOCELE

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

ICSI

About this trial

This is an interventional treatment trial for ICSI AZOOSPERMIA VARICOCELE focused on measuring VARICOCELE-AZOOSPERMIA-ICSI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ajyal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE

Arm Description

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 cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele

Outcomes

Primary Outcome Measures

Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.

Secondary Outcome Measures

Fertilization Rate: percentage of fertilized oocyte.

Embryo Quality: morphological assessment of the developing embryo.

Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.

Full Information

NCT ID

NCT02306499

First Posted

November 22, 2014

Last Updated

November 30, 2014

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT02306499

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

June 2014 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ICSI AZOOSPERMIA VARICOCELE

Keywords

VARICOCELE-AZOOSPERMIA-ICSI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE

Arm Type

Experimental

Arm Description

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

Arm Title

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

ICSI

Intervention Description

Intracytoplasmic Sperm Injection

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Fertilization Rate: percentage of fertilized oocyte.

Time Frame

6/2014 up to one year.

Title

Embryo Quality: morphological assessment of the developing embryo.

Time Frame

6/2014 up to one year.

Title

Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.

Time Frame

6/2014 up to one year.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Alhussini, M.B.B.Ch.

Phone

00201005817574

drhussini@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ramadan Saleh, MD

Phone

00201005423054

salehr2010@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramadan Saleh, MD

Organizational Affiliation

Sohag University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Reham Ezz-Eldawla, MD

Organizational Affiliation

Sohag University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed Yahya, MD

Organizational Affiliation

Sohag University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Muhammed Fawzy

Organizational Affiliation

Ibn Sina Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Ajyal Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramadan Saleh, MD

Phone

01005423054

salehr2010@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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