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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913781
Other study ID # Hawaa-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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