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The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01594645
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
35
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sperm selection by conventional / polarized light microscopy
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. fertilization rate [24-72 h]

      Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.

    Secondary Outcome Measures

    1. Clinical pregnancy [up to 6 weeks]

      The occurrence of clinical pregnancies in both arms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah University Hospital Jerusalem Israel 91120

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: Yoel Shufaro, MD PhD, HMO

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT01594645
    Other Study ID Numbers:
    • 013612- HMO-CTIL
    First Posted:
    May 9, 2012
    Last Update Posted:
    Aug 20, 2015
    Last Verified:
    May 1, 2012
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Aug 20, 2015