ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa

ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men

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.

Study Overview

• Status: Completed
• Conditions: Intracytoplasmic Sperm Injection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 430

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infertile couples

Description

Inclusion Criteria:

• Couples seeking ICSI.

Exclusion Criteria:

• Couples not seeking ICSI.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracytoplasmic sperm injection outcome	Pregnancy rate.	three years

Collaborators and Investigators

• Sponsor: Adam International Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: January 21, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No