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

Sperm Micro-swim up; a Novel Technique to 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)

Study Overview

• Status: Completed
• Conditions: Infertility; Assisted Reproductive Technology
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Daqahlya
    • Mansoura, Daqahlya, Egypt, 35511
      • Royal Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Micro-swim up technique; processing and selection of the sperm for ICSI in the same dish
Experimental: 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	Procedure: Micro-swim up technique; processing and selection of the sperm for ICSI in the same dish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Cleavage rate	The early cleavage rate of oocytes from overall injected oocytes	2 days after ICSI procedure day
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

Collaborators and Investigators

• Sponsor: Royal Fertility Center, Egypt
• Collaborators: Hawaa Fertility Center
• Investigators: Study Director: Sahar SA Eissa, PHD, research team leader; Study Chair: Engy EA Abdallah, MSC, investigator & researcher

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Sperm; ICSI; Semen processing; micro-swim up; density gradient
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocols and outcome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No