Infertility
Conditions
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.
Interventions
OTHERIMSI Procedure
Injection of sperm that has been selected by the MSOME method into oocytes
OTHERStandard ICSI procedure for sperm injection into oocyte
The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes
DEVICEMSOME
Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of fertilization rate | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 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. |
| Pregnancy rate | 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. |
| Miscarriage rate | 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. |
| Live birth rate | 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. |
Countries
Israel
Contacts
Primary ContactMedeia Michaeli, PhD
Outcome results
None listed