A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Infertility

Intervention / Treatment
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* Other: Standard ICSI procedure for sperm injection into oocyte
* Device: MSOME
* Other: IMSI Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICSI Procedure<br>The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte | Other: Standard ICSI procedure for sperm injection into oocyte<br>* The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes<br>|
| Active Comparator: IMSI Procedure<br>The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME) | Device: MSOME<br>* Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification<br>* Other names: Motile Sperm Organelle Morphology Examination;Other: IMSI Procedure<br>* Injection of sperm that has been selected by the MSOME method into oocytes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three years | 
| 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. | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three years | 
| 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. | Three years | 
| 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. | Three years | 
| 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. | Three years |