The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

August 19, 2015 updated by: Hadassah Medical Organization

The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spermatozoa election using a polscope
AR+ spermatozoa are selected for ICSI using a polscope
Procedure: Sperm selection by conventional / polarized light microscopy
Selecting spermatozoa for ICSI using conventional and polarized light microscopy
Other Names:
  • Sperm selection, ICSI, polarized light
Active Comparator: Control
Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy
Procedure: Sperm selection by conventional / polarized light microscopy
Selecting spermatozoa for ICSI using conventional and polarized light microscopy
Other Names:
  • Sperm selection, ICSI, polarized light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fertilization rate
Time Frame: 24-72 h
Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.
24-72 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: up to 6 weeks
The occurrence of clinical pregnancies in both arms.
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Yoel Shufaro, MD PhD, HMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 9, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013612- HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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