Back to resultsThe Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI
Primary Purpose
Infertility
Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Sperm selection by conventional / polarized light microscopy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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.
Sites / Locations
- Hadassah University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spermatozoa election using a polscope
Control
Arm Description
AR+ spermatozoa are selected for ICSI using a polscope
Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy
Outcomes
Primary Outcome Measures
fertilization rate
Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.
Secondary Outcome Measures
Clinical pregnancy
The occurrence of clinical pregnancies in both arms.
Full Information
NCT ID
NCT01594645
First Posted
May 3, 2012
Last Updated
August 19, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01594645
Brief Title
The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI
Official Title
The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Why Stopped
PI moved from Hadassah
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
A prospective RCT to determine the effect of polscope based spermatozoa selection for ICSI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spermatozoa election using a polscope
Arm Type
Experimental
Arm Description
AR+ spermatozoa are selected for ICSI using a polscope
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy
Intervention Type
Procedure
Intervention Name(s)
Sperm selection by conventional / polarized light microscopy
Other Intervention Name(s)
Sperm selection, ICSI, polarized light
Intervention Description
Selecting spermatozoa for ICSI using conventional and polarized light microscopy
Primary Outcome Measure Information:
Title
fertilization rate
Description
Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.
Time Frame
24-72 h
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
The occurrence of clinical pregnancies in both arms.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoel Shufaro, MD PhD
Organizational Affiliation
HMO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI
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