The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Hadassah Medical Center

Status and phase: Withdrawn; Phase 1

Conditions: Infertility

Treatments: Procedure: Sperm selection by conventional / polarized light microscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01594645

013612- HMO-CTIL

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Spermatozoa election using a polscope

Experimental group

Description:

AR+ spermatozoa are selected for ICSI using a polscope

Treatment:

Procedure: Sperm selection by conventional / polarized light microscopy

Control

Active Comparator group

Description:

Spermatozoa for ICSI are selected based on morphology and motion under conventional light microscopy

Treatment:

Procedure: Sperm selection by conventional / polarized light microscopy