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

NCT ID: NCT02306499

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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ICSI AZOOSPERMIA VARICOCELE

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ICSI

Intervention Type PROCEDURE

Intracytoplasmic Sperm Injection

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

Group Type EXPERIMENTAL

ICSI

Intervention Type PROCEDURE

Intracytoplasmic Sperm Injection

Interventions

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ICSI

Intracytoplasmic Sperm Injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Al-Hussini Jad Abdel-latif, M.B.B.Ch.

Egypt - Sohag - Nasser City - Sohag University - Faculty Of Medicine - Dermatology, Venereology and Andrology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramadan Saleh, MD

Role: STUDY_DIRECTOR

Sohag University

Reham Ezz-Eldawla, MD

Role: STUDY_DIRECTOR

Sohag University

Mohamed Yahya, MD

Role: STUDY_DIRECTOR

Sohag University

Muhammed Fawzy

Role: STUDY_DIRECTOR

Ibn Sina Hospital

Locations

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Ajyal Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Alhussini, M.B.B.Ch.

Role: CONTACT

[email protected]
00201005817574

Ramadan Saleh, MD

Role: CONTACT

[email protected]
00201005423054

Facility Contacts

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Ramadan Saleh, MD

Role: primary

[email protected]
01005423054

Other Identifiers

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729/259/2014

Identifier Type: OTHER

Identifier Source: secondary_id

729/2014

Identifier Type: -

Identifier Source: org_study_id