Back to resultsNovel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor (CISC)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Oocyte double chemical activation
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- poor sperm
- poor quality Oocytes
- previous failed fertilization
- previous poor embryogenesis
Exclusion Criteria:
- normal patient
- previous successful outcome
Sites / Locations
- Al Barka fertility center
- Banon fertility center
- IbnSina IVF unit, IbnSina Hospital, El Areef Square
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Double activation
Control arm
Arm Description
The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.
The Oocytes will undergo Intracytoplasmic sperm injection only
Outcomes
Primary Outcome Measures
Clinical Pregnancy rate ( % )
To predict percentage of pregnant women from those will undergo Embryo transfer
Secondary Outcome Measures
Blastocyst rate ( % )
Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection
Full Information
NCT ID
NCT02418416
First Posted
April 6, 2015
Last Updated
September 25, 2018
Sponsor
Ibn Sina Hospital
Collaborators
Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT02418416
Brief Title
Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor
Acronym
CISC
Official Title
Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 6, 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.
Detailed Description
In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.
We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double activation
Arm Type
Experimental
Arm Description
The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
The Oocytes will undergo Intracytoplasmic sperm injection only
Intervention Type
Other
Intervention Name(s)
Oocyte double chemical activation
Intervention Description
Oocyte double chemical activation
Primary Outcome Measure Information:
Title
Clinical Pregnancy rate ( % )
Description
To predict percentage of pregnant women from those will undergo Embryo transfer
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blastocyst rate ( % )
Description
Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
poor sperm
poor quality Oocytes
previous failed fertilization
previous poor embryogenesis
Exclusion Criteria:
normal patient
previous successful outcome
Facility Information:
Facility Name
Al Barka fertility center
City
Bahrain
Country
Bahrain
Facility Name
Banon fertility center
City
Assiut
Country
Egypt
Facility Name
IbnSina IVF unit, IbnSina Hospital, El Areef Square
City
Sohag
ZIP/Postal Code
12345
Country
Egypt
12. IPD Sharing Statement
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Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor
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