- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03240276
A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method
August 2, 2017 updated by: Hillel Yaffe Medical Center
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)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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H̱adera, Israel, 38100
- Hillel Yaffe Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ICSI Procedure
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte
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The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes
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ACTIVE_COMPARATOR: IMSI Procedure
The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
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Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification
Other Names:
Injection of sperm that has been selected by the MSOME method into oocytes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of fertilization rate
Time Frame: Three years
|
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.
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Three years
|
Comparison of embryo quality
Time Frame: Three years
|
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.
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implantation rate
Time Frame: Three years
|
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.
|
Three years
|
Pregnancy rate
Time Frame: Three years
|
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.
|
Three years
|
Miscarriage rate
Time Frame: Three years
|
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.
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Three years
|
Live birth rate
Time Frame: Three years
|
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.
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medeia Michaeli, PhD, Hillel Yaffe Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2017
Primary Completion (ANTICIPATED)
September 1, 2020
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
July 31, 2017
First Submitted That Met QC Criteria
August 2, 2017
First Posted (ACTUAL)
August 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 7, 2017
Last Update Submitted That Met QC Criteria
August 2, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYMC-0070-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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