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

Not Applicable

Completed

• Conditions: Fertilization
• Interventions: Procedure: polar body removal using zona drilling by laser then suction by injecting pipette; Procedure: Classic ICSI

• Registration Number: NCT02913781
• Lead Sponsor: Benha University

Brief Summary

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

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-09-03
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-09
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• previous fertilization failure
• previous fertilization arrest

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
polar body removal	polar body removal using zona drilling by laser then suction by injecting pipette	polar body removal by zona drilling with laser then suction by injecting pipette then ICSI procedure is done
polar body removal	Classic ICSI	polar body removal by zona drilling with laser then suction by injecting pipette then ICSI procedure is done

Primary Outcome Measures

Name	Time	Method
fertilization rate of the zygotes	16-20 hours post ICSI	fertilization check is done under inverted microscopy by 2PN check

Secondary Outcome Measures

Name	Time	Method
division rate of the embryos by the number of the blastomeres.	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.

Trial Locations

Locations (1)

Banha University- Hawaa Fertility center; 🇪🇬 Banha, Qalyubiya, Egypt