Polar Body Removal Before ICSI for Oocyte Activation in Previous Fertilization Failure Cases (PBRBICSI)

September 9, 2018 updated by: Ahmed Saad, Benha University

Polar Body Removal Before ICSI as a Method of Oocyte Activation in Previous Fertilization Failure Cases

Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle with removal of the polar body just before the ICSI procedure and sperm injection at the site of polar body removal. This study group will be evaluated with another group with the classic ICSI procedure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with previous fertilization failure will be divided into 2 groups:

Group 1 (control): Will undergo classic ICSI procedure in half the MII oocyte of the same case.

Group 2 (study group): The other half of the MII oocyte of the same case will undergo:

  1. Polar body removal.
  2. ICSI procedure with injection of the spermatozoon in the same zona opening (done by laser for polar body removal).

Results: Will be collected with evaluation of number of 2PN zygotes, Day 1, Day 2, Day 3, Day 5 embryos in all the cases.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubiya
      • Banha, Qalyubiya, Egypt, 13512
        • Banha University- Hawaa Fertility center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • previous fertilization failure
  • previous fertilization arrest

Exclusion Criteria:

  • NO MII oocyte
  • Refusal of the procedure by the couple

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: polar body removal
polar body removal by zona drilling with laser then suction by injecting pipette then ICSI procedure is done
Procedure: polar body removal using zona drilling by laser then suction by injecting pipette
zona drilling with laser followed by polar body removal then ICSI procedure
Procedure: Classic ICSI
Classic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fertilization rate of the zygotes
Time Frame: 16-20 hours post ICSI
fertilization check is done under inverted microscopy by 2PN check
16-20 hours post ICSI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
division rate of the embryos by the number of the blastomeres.
Time Frame: Day 2 & 3 & 5
Detection of the number of the blastomeres and quality of the embryos under inverted microscopy. At day 5, detection of the rate of the blastocyst formation and quality of the embryos.
Day 2 & 3 & 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Collaborators

Hawaa Fertility Center

Investigators

  • Study Chair: Ahmed Saad, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 3, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 9, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hawaa-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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