A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI 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. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)

Conditions
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Infertility

Intervention / Treatment
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* Device: ICSI petri dish
* Device: PICSI petri dish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged 18-60 Females aged 18-35 Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle Males with normozoospermia with at least 2 unexplained failed IVF cycles Females with normal FSH and normal AMH values Females who have retrieved in previous cycles at least 6 oocytes 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 using a standard ICSI petri dish. | Device: ICSI petri dish<br>* Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.<br>|
| Active Comparator: PICSI Procedure<br>The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom. | Device: PICSI petri dish<br>* Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.<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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 PICSI methods will be compared. | Three years |