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Completed

NCT Number: NCT02913781

Polar Body Removal Before ICSI for 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

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Key information

Conditions

Fertilization

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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:

  • Polar body removal.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previous fertilization failure
  • previous fertilization arrest

Exclusion criteria

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

Treatment and study plan

polar body removal using zona drilling by laser then suction by injecting pipette

Procedure

zona drilling with laser followed by polar body removal then ICSI procedure

Classic ICSI

Procedure

Classic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position.

Primary outcomes

  1. fertilization rate of the zygotes

    Time frame: 16-20 hours post ICSI

    fertilization check is done under inverted microscopy by 2PN check

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Hawaa Fertility Center

Registry information

Official study title

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

Acronym: PBRBICSI

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 26, 2016
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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