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

Fertilization Clinical Trial

— PBRBICSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913781
• Other study ID #: Hawaa-2
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• previous fertilization failure

• previous fertilization arrest

Exclusion Criteria:

• NO MII oocyte

• Refusal of the procedure by the couple

Related Conditions & MeSH terms

• Fertilization

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Banha University- Hawaa Fertility center	Banha	Qalyubiya

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fertilization rate of the zygotes	fertilization check is done under inverted microscopy by 2PN check	16-20 hours post ICSI
Secondary	division rate of the embryos by the number of the blastomeres.	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