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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2021-12-30

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)

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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

Conditions

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Assisted Reproductive Technology Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Micro-swim up technique

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

Micro-swim up technique

Intervention Type PROCEDURE

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

Interventions

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Micro-swim up technique

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

Intervention Type PROCEDURE

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