Back to resultsA Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Standard ICSI procedure for sperm injection into oocyte
MSOME
IMSI Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Males aged 18-60
- Females aged 18-35
- Males defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
- Patients with 0.5- 7% normal sperm according to MSOME analysis
- Females with normal FSH and AMH values
- Females who have retrieved at least 6 oocytes in previous cycles
- Couples who have had at least 2 failed IVF-ICSI cycles
Exclusion Criteria:
- Couples who have been exposed to heavy smoking, drugs and chronic diseases
- Males who have undergone testicular surgery (TESE) or defined as severe OTA
- Females with egg factor infertility
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ICSI Procedure
IMSI Procedure
Arm Description
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte
The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
Outcomes
Primary Outcome Measures
Comparison of fertilization rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and IMSI methods will be compared.
Comparison of embryo quality
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and IMSI methods will be compared.
Secondary Outcome Measures
Implantation rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and IMSI methods will be compared.
Pregnancy rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and IMSI methods will be compared.
Miscarriage rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and IMSI methods will be compared.
Live birth rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and IMSI methods will be compared.
Full Information
NCT ID
NCT03240276
First Posted
July 31, 2017
Last Updated
August 2, 2017
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03240276
Brief Title
A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method
Official Title
A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. an Ultra Morphology Section Method - Intracytoplasmic Morphology Selected Sperm Injection (IMSI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICSI Procedure
Arm Type
Active Comparator
Arm Description
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte
Arm Title
IMSI Procedure
Arm Type
Active Comparator
Arm Description
The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
Intervention Type
Other
Intervention Name(s)
Standard ICSI procedure for sperm injection into oocyte
Intervention Description
The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes
Intervention Type
Device
Intervention Name(s)
MSOME
Other Intervention Name(s)
Motile Sperm Organelle Morphology Examination
Intervention Description
Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification
Intervention Type
Other
Intervention Name(s)
IMSI Procedure
Intervention Description
Injection of sperm that has been selected by the MSOME method into oocytes
Primary Outcome Measure Information:
Title
Comparison of fertilization rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and IMSI methods will be compared.
Time Frame
Three years
Title
Comparison of embryo quality
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and IMSI methods will be compared.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Implantation rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and IMSI methods will be compared.
Time Frame
Three years
Title
Pregnancy rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and IMSI methods will be compared.
Time Frame
Three years
Title
Miscarriage rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and IMSI methods will be compared.
Time Frame
Three years
Title
Live birth rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and IMSI methods will be compared.
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males aged 18-60
Females aged 18-35
Males defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
Patients with 0.5- 7% normal sperm according to MSOME analysis
Females with normal FSH and AMH values
Females who have retrieved at least 6 oocytes in previous cycles
Couples who have had at least 2 failed IVF-ICSI cycles
Exclusion Criteria:
Couples who have been exposed to heavy smoking, drugs and chronic diseases
Males who have undergone testicular surgery (TESE) or defined as severe OTA
Females with egg factor infertility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medeia Michaeli, PhD
Phone
972-50-6246885
Email
medeia.michaeli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Shalom Paz, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Medeia Michaeli, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
H̱adera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medeia Michaeli, PhD
Phone
972-50-6246885
Email
medeia.michaeli@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method
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