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

Not Applicable

Completed

• Conditions: Assisted Reproductive Technology; Infertility
• Interventions: Procedure: Micro-swim up technique

• Registration Number: NCT05113225
• Lead Sponsor: Royal Fertility Center, Egypt

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

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-08
• Study Start: 2021-10-10
• Study First Submitted QC: 2021-11-07
• Study First Posted: 2021-11-09
• Primary Completion: 2021-12-25
• Study Completion: 2021-12-30
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DG-ICSI	Micro-swim up technique	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
H pattern-ICSI	Micro-swim up technique	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Early Cleavage rate	2 days after ICSI procedure day	The early cleavage rate of oocytes from overall injected oocytes

Trial Locations

Locations (1)

Royal Fertility Center; 🇪🇬 Mansoura, Daqahlya, Egypt