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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113225
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2021
• Source: Royal Fertility Center, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 30, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Assisted Reproductive Technology
• Infertility

Intervention

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

Locations

Country	Name	City	State
Egypt	Royal Fertility Center	Mansoura	Daqahlya

Sponsors (2)

Lead Sponsor	Collaborator
Royal Fertility Center, Egypt	Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of top quality embryos	the number of best embryos in each arm in Day 4 or Day 5	4 or 5 days after ICSI procedure day
Secondary	Early Cleavage rate	The early cleavage rate of oocytes from overall injected oocytes	2 days after ICSI procedure day
Secondary	chemical pregnancy rate	the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases	14 days after embryo transfer day