The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01594645
First received: May 3, 2012
Last updated: May 13, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Infertility
Procedure: Sperm selection by conventional / polarized light microscopy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • fertilization rate [ Time Frame: 24-72 h ] [ Designated as safety issue: No ]
    Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.


Secondary Outcome Measures:
  • Clinical pregnancy [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    The occurrence of clinical pregnancies in both arms.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sperm selection, ICSI, polarized light

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594645

Contacts
Contact: Yoel Shufaro, MD PhD yoel.shufaro@gmail.com

Locations
Israel
Hadassah University Hospital Not yet recruiting
Jerusalem, Israel, 91120
Contact: Yoel Shufaro       yoel.shufaro@gmail.com   
Principal Investigator: Yoel Shufaro, MD PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoel Shufaro, MD PhD HMO
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01594645     History of Changes
Other Study ID Numbers: 013612- HMO-CTIL
Study First Received: May 3, 2012
Last Updated: May 13, 2012
Health Authority: Israel: Ministry of Health - Director General

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014