Back to resultsSuccessful Pregnancy and Delivery After AOA
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Calcium ionophore
Strontium chloride (SrCl2)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Fertilization failure, calcium ionophore, SrCl2
Eligibility Criteria
Inclusion Criteria:
- Fertilization rate was less than 30% after conventional ICSI.
- Fertilization rate was less than 50% after ICSI with calcium ionophore.
- Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles
Exclusion Criteria:
- Fertilization rate was more than 30% after conventional ICSI
- Fertilization rate was more than 50% after ICSI with calcium ionophore.
- Successful pregnancy and delivery after ICSI in previous cycles
Sites / Locations
- Maria Fertility Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional ICSI
Convention ICSI
Arm Description
The couple showed complete fertilization failure after ICSI.
The couple showed a low fertilization rates after ICSI.
Outcomes
Primary Outcome Measures
Fertilization rate
Secondary Outcome Measures
Embryo quality
Pregnancy and Implantation rates
Assessment of Infant health care
This assessment is according to the standard set by the National Health Insurance Service (NHIS) in Korea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01595815
Brief Title
Successful Pregnancy and Delivery After AOA
Official Title
Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Fertility Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Fertilization failure, calcium ionophore, SrCl2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional ICSI
Arm Type
Active Comparator
Arm Description
The couple showed complete fertilization failure after ICSI.
Arm Title
Convention ICSI
Arm Type
Active Comparator
Arm Description
The couple showed a low fertilization rates after ICSI.
Intervention Type
Other
Intervention Name(s)
Calcium ionophore
Intervention Description
Oocytes were activated with calcium ionophore after ICSI
Intervention Type
Other
Intervention Name(s)
Strontium chloride (SrCl2)
Intervention Description
Oocytes were activated with strontium chloride after ICSI
Primary Outcome Measure Information:
Title
Fertilization rate
Time Frame
18 hours
Secondary Outcome Measure Information:
Title
Embryo quality
Time Frame
3 Days
Title
Pregnancy and Implantation rates
Time Frame
2 months
Title
Assessment of Infant health care
Description
This assessment is according to the standard set by the National Health Insurance Service (NHIS) in Korea.
Time Frame
birth and at 3, 6, 12, 24, 36, 60, and 72 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fertilization rate was less than 30% after conventional ICSI.
Fertilization rate was less than 50% after ICSI with calcium ionophore.
Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles
Exclusion Criteria:
Fertilization rate was more than 30% after conventional ICSI
Fertilization rate was more than 50% after ICSI with calcium ionophore.
Successful pregnancy and delivery after ICSI in previous cycles
Facility Information:
Facility Name
Maria Fertility Hospital
City
Seoul
ZIP/Postal Code
138-160
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25592974
Citation
Kim JW, Yang SH, Yoon SH, Kim SD, Jung JH, Lim JH. Successful pregnancy and delivery after ICSI with artificial oocyte activation by calcium ionophore in in-vitro matured oocytes: a case report. Reprod Biomed Online. 2015 Apr;30(4):373-7. doi: 10.1016/j.rbmo.2014.11.014. Epub 2014 Dec 11.
Results Reference
derived
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Successful Pregnancy and Delivery After AOA
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