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ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033563
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmad Raef Sadek, Adam International Hospital

Brief Summary:
The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.

Condition or disease Intervention/treatment
Intracytoplasmic Sperm Injection Procedure: Intracytoplasmic sperm injection

Detailed Description:

The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in this study.

First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if no motile sperm was available. For failed cases a second cycle was repeated using either testicular sperm or ejaculated sperm.

Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.

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Study Type : Observational
Actual Enrollment : 430 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : December 1, 2014
Actual Study Completion Date : December 31, 2014

Group/Cohort Intervention/treatment
Testicular tissue versus ejaculate
Evaluation of ICSI outcome.
Procedure: Intracytoplasmic sperm injection
Intracytoplasmic sperm injection




Primary Outcome Measures :
  1. Intracytoplasmic sperm injection outcome [ Time Frame: three years ]
    Pregnancy rate.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infertile couples
Criteria

Inclusion Criteria:

  • Couples seeking ICSI.

Exclusion Criteria:

  • Couples not seeking ICSI.
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Responsible Party: Ahmad Raef Sadek, Dr. Ahmad Raef, Adam International Hospital
ClinicalTrials.gov Identifier: NCT03033563    
Other Study ID Numbers: 2017
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No