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

Royal Fertility Center, Egypt

Status: Completed

Conditions: Infertility; Assisted Reproductive Technology

Treatments: Procedure: Micro-swim up technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05113225

002

Details and patient eligibility

About

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)

Full 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

Enrollment: 156 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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156 participants in 2 patient groups

DG-ICSI

Active Comparator group

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

Treatment:

Procedure: Micro-swim up technique

H pattern-ICSI

Experimental group

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

Treatment:

Procedure: Micro-swim up technique