NCT02913781

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

September 3, 2016

Last Update Submit

September 9, 2018

Conditions

Fertilization

Keywords

Polar body removalICSIFertilization failure

Outcome Measures

Primary Outcomes (1)

  • fertilization rate of the zygotes

    fertilization check is done under inverted microscopy by 2PN check

    16-20 hours post ICSI

Secondary Outcomes (1)

  • division rate of the embryos by the number of the blastomeres.

    Day 2 & 3 & 5

Study Arms (1)

polar body removal

EXPERIMENTAL

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 pipetteProcedure: Classic ICSI

Interventions

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

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

polar body removal
Classic ICSIPROCEDURE

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

polar body removal

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • previous fertilization failure
  • previous fertilization arrest

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Study Officials

  • Ahmed Saad

    Benha University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ob.&Gyn.

Study Record Dates

First Submitted

September 3, 2016

First Posted

September 26, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

EG(1)