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The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

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

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01594645
Enrollment
0
Registered
2012-05-09
Start date
2012-09-30
Completion date
2015-08-31
Last updated
2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

PROCEDURESperm selection by conventional / polarized light microscopy

Selecting spermatozoa for ICSI using conventional and polarized light microscopy

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fertilization rate24-72 hDetermine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.

Secondary

MeasureTime frameDescription
Clinical pregnancyup to 6 weeksThe occurrence of clinical pregnancies in both arms.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026