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)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Comparison of fertilization rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ICSI Procedure
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte
Intervention: Standard ICSI procedure for sperm injection into oocyte (Other)
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)
Intervention: MSOME (Device)
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)
Intervention: IMSI Procedure (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Pregnancy rate(Three years)
- Implantation rate(Three years)
- Miscarriage rate(Three years)
- Live birth rate(Three years)