Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design

Study Overview
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Brief Summary
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A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique)

Detailed Description
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In This study investigators compare a novel sperm processing and selection method which is (fast, cheap and safe) with the well known processing method of sperm Density gradient (DG) The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10 μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid with mineral oil. Control group : Oocytes will be injected using sperm after processing with DG and will be selected from control PVP microdroplets Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP microdroplets is prepared on H Pattern and will be selected from the far point from the deposition point and will be injected into the oocytes from the sample group All injected MII oocytes from both groups will then be cultured, with each group demarcated in separate place in the culture dish then according to the randomisation embryo transfer will be selected from one of both groups then the quality of the embryos will be reported and the pregnancy rate

Official Title
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Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)

Conditions
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Assisted Reproductive Technology, Infertility

Intervention / Treatment
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* Procedure: Micro-swim up technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The normal & high responders were selected according to : age: 18 - 40 years anti-Müllerian hormone (AMH): > 1.0 ng/ml number of aspirated oocytes:more than or equal 8 BMI < 34 Exclusion Criteria: Age > 40 years; AMH < 1.0 ng/mL; aspirated oocytes < 8. severe male factor Testicular aspirated sperm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

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: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single group of patients will be recruited in the study and each patient's oocytes will be divided into two groups and each group of patients will be injected with sperm processed by normal DG or H pattern micro- swim up technique. The PVP was used to produce the H pattern (length of about 2 cm from one side of the plate to the middle of the disk, total volume 10 μL). A small amount of semen (3 μL) was placed on one side of the H, and some time was allowed for it to migrate to the other side where the sperm was then collected. The dishes were incubated for three minutes allowing sperm migration along the outer perimeter of the H. After the completion of sperm migration, the plate was turned before the upload to avoid the contamination of the injection pipette by the sample.The injection pipette was introduced into the H-ICSI™ and used to immobilize a single sperm by crushing the membrane of its tail.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DG-ICSI<br>Oocytes of this arm will be injected using sperm previously processed by DG method and located in the commonly used ICSI dishes with the common PVP microdroplets | Procedure: Micro-swim up technique<br>* processing and selection of the sperm for ICSI in the same dish<br>|
| Experimental: H pattern-ICSI<br>Oocytes of this arm will be injected using sperm that directly located in a specific H pattern PVP droplets in a commonly used ICSI dishes without pre-processing of the semen | Procedure: Micro-swim up technique<br>* processing and selection of the sperm for ICSI in the same dish<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of top quality embryos | the number of best embryos in each arm in Day 4 or Day 5 | 4 or 5 days after ICSI procedure day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Cleavage rate | The early cleavage rate of oocytes from overall injected oocytes | 2 days after ICSI procedure day | 
| chemical pregnancy rate | the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases | 14 days after embryo transfer day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sperm, micro-swim up, ICSI, Semen processing, density gradient