The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Study Overview
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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.

Official Title
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The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Sperm selection by conventional / polarized light microscopy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spermatozoa election using a polscope<br>AR+ spermatozoa are selected for ICSI using a polscope | Procedure: Sperm selection by conventional / polarized light microscopy<br>* Selecting spermatozoa for ICSI using conventional and polarized light microscopy<br>* Other names: Sperm selection, ICSI, polarized light;|
| Active Comparator: Control<br>Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy | Procedure: Sperm selection by conventional / polarized light microscopy<br>* Selecting spermatozoa for ICSI using conventional and polarized light microscopy<br>* Other names: Sperm selection, ICSI, polarized light;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate | Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development. | 24-72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | The occurrence of clinical pregnancies in both arms. | up to 6 weeks |