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Completed

NCT Number: NCT05113225

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

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Fertility Center

Al Mansurah, Daqahlya, 35511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micro-swim up technique

Procedure

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

Primary outcomes

  1. Number of top quality embryos

    Time frame: 4 or 5 days after ICSI procedure day

    the number of best embryos in each arm in Day 4 or Day 5

Secondary outcomes

  1. Early Cleavage rate

    Time frame: 2 days after ICSI procedure day

    The early cleavage rate of oocytes from overall injected oocytes

  2. chemical pregnancy rate

    Time frame: 14 days after embryo transfer day

    the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases

Sponsors and collaborators

Lead sponsor

Royal Fertility Center, Egypt

Other

Collaborators

  • Hawaa Fertility Center

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2021
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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