Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
Primary Purpose
Assisted Reproductive Technology, Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Micro-swim up technique
Sponsored by
About this trial
This is an interventional treatment trial for Assisted Reproductive Technology focused on measuring Sperm, micro-swim up, ICSI, Semen processing, density gradient
Eligibility Criteria
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
Sites / Locations
- Royal Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
DG-ICSI
H pattern-ICSI
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of top quality embryos
the number of best embryos in each arm in Day 4 or Day 5
Secondary Outcome Measures
Early Cleavage rate
The early cleavage rate of oocytes from overall injected oocytes
chemical pregnancy rate
the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases
Full Information
NCT ID
NCT05113225
First Posted
October 8, 2021
Last Updated
June 22, 2022
Sponsor
Royal Fertility Center, Egypt
Collaborators
Hawaa Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT05113225
Brief Title
Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
Official Title
Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
December 25, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Fertility Center, Egypt
Collaborators
Hawaa Fertility Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assisted Reproductive Technology, Infertility
Keywords
Sperm, micro-swim up, ICSI, Semen processing, density gradient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
ParticipantCare Provider
Masking Description
the oocytes of each patient will be randomly divided before denudation and will be distributed in the ICSI dishes of different previously described PVP pattern and sperm processing
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DG-ICSI
Arm Type
Active Comparator
Arm Description
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
Arm Title
H pattern-ICSI
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Micro-swim up technique
Intervention Description
processing and selection of the sperm for ICSI in the same dish
Primary Outcome Measure Information:
Title
Number of top quality embryos
Description
the number of best embryos in each arm in Day 4 or Day 5
Time Frame
4 or 5 days after ICSI procedure day
Secondary Outcome Measure Information:
Title
Early Cleavage rate
Description
The early cleavage rate of oocytes from overall injected oocytes
Time Frame
2 days after ICSI procedure day
Title
chemical pregnancy rate
Description
the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases
Time Frame
14 days after embryo transfer day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar SA Eissa, PHD
Organizational Affiliation
research team leader
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Engy EA Abdallah, MSC
Organizational Affiliation
investigator & researcher
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Fertility Center
City
Mansoura
State/Province
Daqahlya
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study protocols and outcome
Learn more about this trial
Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
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