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

Sponsor

Royal Fertility Center, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT05113225

Collaborator

Hawaa Fertility Center (Other)

156

Enrollment

Location

Arms

2.7

Actual Duration (Months)

58.6

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Assisted Reproductive Technology Infertility	Procedure: Micro-swim up technique	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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 (Participant, Care 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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2021

Actual Primary Completion Date :

Dec 25, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

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	Procedure: Micro-swim up technique 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	Procedure: Micro-swim up technique processing and selection of the sperm for ICSI in the same dish

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

Procedure: Micro-swim up technique

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

Procedure: Micro-swim up technique

processing and selection of the sperm for ICSI in the same dish

Outcome Measures

Primary Outcome Measures

Number of top quality embryos [4 or 5 days after ICSI procedure day]
the number of best embryos in each arm in Day 4 or Day 5

Secondary Outcome Measures

Early Cleavage rate [2 days after ICSI procedure day]
The early cleavage rate of oocytes from overall injected oocytes
chemical pregnancy rate [14 days after embryo transfer day]
the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Fertility Center	Mansoura	Daqahlya	Egypt	35511

Sponsors and Collaborators

Royal Fertility Center, Egypt
Hawaa Fertility Center

Investigators

Study Director: Sahar SA Eissa, PHD, research team leader
Study Chair: Engy EA Abdallah, MSC, investigator & researcher

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Fertility Center, Egypt

ClinicalTrials.gov Identifier:

NCT05113225

Other Study ID Numbers:

First Posted:

Nov 9, 2021

Last Update Posted:

Jun 23, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Royal Fertility Center, Egypt

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jun 23, 2022