FertilizationPBRBICSINCT02913781
Polar Body Removal Before ICSI for Oocyte Activation in Previous Fertilization Failure Cases
A study testing polar body removal using zona drilling by laser then suction by injecting pipette and Classic ICSI in people with Fertilization, run by Benha University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertilization
- What is being tested?
- polar body removal using zona drilling by laser then suction by injecting pipette and Classic ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- previous fertilization failure
- previous fertilization arrest
Who cannot join
- NO MII oocyte
- Refusal of the procedure by the couple
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Banha University- Hawaa Fertility center
Banhā, Qalyubia Governorate, 13512
About this study
Official title: Polar Body Removal Before ICSI as a Method of 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
Read the 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:
- 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.
- Conditions
- Fertilization
- Being tested
- polar body removal using zona drilling by laser then suction by injecting pipette, Classic ICSI
- Keywords
- Polar body removal, ICSI, Fertilization failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polar body removal using zona drilling by laser then suction by injecting pipetteProcedure or surgery
zona drilling with laser followed by polar body removal then ICSI procedure
Classic ICSIProcedure or surgery
Classic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position.
| Study group | Role | What they receive |
|---|---|---|
| polar body removal | Experimental | polar body removal by zona drilling with laser then suction by injecting pipette then ICSI procedure is done Receives: Procedure: polar body removal using zona drilling by laser then suction by injecting pipette; Procedure: Classic ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate of the zygotes
fertilization check is done under inverted microscopy by 2PN check
Measured: 16-20 hours post ICSI
Secondary outcomes (1)
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.
Measured: Day 2 & 3 & 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilizationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Principal investigator, Ahmed Saad, Benha University
- Investigators
- Ahmed Saad, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913781
- Sponsor's protocol ID
- Hawaa-2
- Acronym
- PBRBICSI
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polar Body Removal Before ICSI as a Method of Oocyte Activation in Previous Fertilization Failure Cases
- ClinicalTrials.gov ID
- NCT02913781
- Acronym / sponsor ID
- PBRBICSI / Hawaa-2
- Conditions
- Fertilization
- Keywords
- Polar body removal, ICSI, Fertilization failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polar body removal | Experimental | Procedure: polar body removal using zona drilling by laser then suction by injecting pipette, Procedure: Classic ICSIpolar body removal by zona drilling with laser then suction by injecting pipette then ICSI procedure is done |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- previous fertilization failure
- previous fertilization arrest
Key exclusion criteria (2 listed)
- NO MII oocyte
- Refusal of the procedure by the couple
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polar body removal using zona drilling by laser then suction by injecting pipettezona drilling with laser followed by polar body removal then ICSI procedure | Procedure or surgery | polar body removal |
| Classic ICSIClassic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position. | Procedure or surgery | polar body removal |
Primary outcome
fertilization rate of the zygotes
Time frame: 16-20 hours post ICSI
fertilization check is done under inverted microscopy by 2PN check
1 secondary outcome
division rate of the embryos by the number of the blastomeres.
Time frame: Day 2 & 3 & 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Saad study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polar body removal using zona drilling by laser then suction by injecting pipette and Classic ICSI in people with Fertilization, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertilization rate of the zygotes (time frame: 16-20 hours post ICSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.