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The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Phase 1
Withdrawn
Conditions
Infertility
Registration Number
NCT01594645
Lead Sponsor
Hadassah Medical Organization
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
fertilization rate24-72 h

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

Secondary Outcome Measures
NameTimeMethod
Clinical pregnancyup to 6 weeks

The occurrence of clinical pregnancies in both arms.

Trial Locations

Locations (1)

Hadassah University Hospital

🇮🇱

Jerusalem, Israel

Hadassah University Hospital
🇮🇱Jerusalem, Israel

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