Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Daqahlya
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Mansoura, Daqahlya, Egypt, 35511
- Royal Fertility Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: DG-ICSI
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
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processing and selection of the sperm for ICSI in the same dish
|
|
Experimental: H pattern-ICSI
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
|
processing and selection of the sperm for ICSI in the same dish
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of top quality embryos
Time Frame: 4 or 5 days after ICSI procedure day
|
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
Time Frame: 2 days after ICSI procedure day
|
The early cleavage rate of oocytes from overall injected oocytes
|
2 days after ICSI procedure day
|
|
chemical pregnancy rate
Time Frame: 14 days after embryo transfer day
|
the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases
|
14 days after embryo transfer day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sahar SA Eissa, PHD, research team leader
- Study Chair: Engy EA Abdallah, MSC, investigator & researcher
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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