The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Phase 1

Withdrawn

• Conditions: Infertility
• Interventions: Procedure: Sperm selection by conventional / polarized light microscopy

• Registration Number: NCT01594645
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Presently spermatozoa for ICSI are selected based on morphology and motion, without determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be an indicator of better spermatozoon quality and implantation potential, especially in severe OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using polarized light microscopy due to different bifriengance.

In this study the investigators seek to determine, by a prospective RCT, if selecting only acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the entire IVF process.

Detailed Description

A prospective RCT to determine the effect of polscope based spermatozoa selection for ICSI.

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Study Start: 2012-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Female: normal uterine cavity and ovarian reserve. Male: TMC < 1000000 cells.

Exclusion Criteria

• Female: Abnormal uterine anatomy, low ovarian reserve, contributing egg factor, PGD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sperm selection by conventional / polarized light microscopy	Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy
Spermatozoa election using a polscope	Sperm selection by conventional / polarized light microscopy	AR+ spermatozoa are selected for ICSI using a polscope

Primary Outcome Measures

Name	Time	Method
fertilization rate	24-72 h	Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	up to 6 weeks	The occurrence of clinical pregnancies in both arms.

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel