The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01594645
• Other study ID #: 013612- HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1
• First received: May 3, 2012
• Last updated: August 19, 2015
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: May 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health - Director General
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Sperm selection by conventional / polarized light microscopy
Selecting spermatozoa for ICSI using conventional and polarized light microscopy

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fertilization rate	Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.	24-72 h	No
Secondary	Clinical pregnancy	The occurrence of clinical pregnancies in both arms.	up to 6 weeks	No