The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

NCT ID: NCT01594645

Last Updated: 2015-08-20

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-08-31

Brief Summary

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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

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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spermatozoa election using a polscope

AR+ spermatozoa are selected for ICSI using a polscope

Group Type EXPERIMENTAL

Sperm selection by conventional / polarized light microscopy

Intervention Type PROCEDURE

Selecting spermatozoa for ICSI using conventional and polarized light microscopy

Control

Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy

Group Type ACTIVE_COMPARATOR

Sperm selection by conventional / polarized light microscopy

Intervention Type PROCEDURE

Selecting spermatozoa for ICSI using conventional and polarized light microscopy

Interventions

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Sperm selection by conventional / polarized light microscopy

Selecting spermatozoa for ICSI using conventional and polarized light microscopy

Intervention Type PROCEDURE

Other Intervention Names

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Sperm selection, ICSI, polarized light

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoel Shufaro, MD PhD

Role: PRINCIPAL_INVESTIGATOR

HMO

Locations

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Hadassah University Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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013612- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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