The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

NCT01594645 | Withdrawn Phase 1

• 1 other identifier: 013612- HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• fertilization rate

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

  24-72 h

Secondary Outcomes (1)

• Clinical pregnancy

  up to 6 weeks

Study Arms (2)

Spermatozoa election using a polscope

EXPERIMENTAL

AR+ spermatozoa are selected for ICSI using a polscope

Procedure: Sperm selection by conventional / polarized light microscopy

Control

ACTIVE COMPARATOR

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

Procedure: Sperm selection by conventional / polarized light microscopy

Interventions

Sperm selection by conventional / polarized light microscopy PROCEDURE

Selecting spermatozoa for ICSI using conventional and polarized light microscopy

Also known as: Sperm selection, ICSI, polarized light

Control; Spermatozoa election using a polscope

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female: normal uterine cavity and ovarian reserve. Male: TMC \< 1000000 cells.

You may not qualify if:

• Female: Abnormal uterine anatomy, low ovarian reserve, contributing egg factor, PGD.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

Microscopy, Polarization; Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics

Study Officials

• Yoel Shufaro, MD PhD

  HMO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 9, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2012-05

Locations

IL (1)