Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B (ICSI-CB)

Cytochalasin B Supplementation to ICSI Handling Medium

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Cytochalasin B use in ICSI handling medium

• Study Type: Interventional
• Enrollment (Actual): 987
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • IbnSina IVF 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:

• All ICSI candidates patients

Exclusion Criteria:

• No exclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Handling Medium Supplemented with Cytochalasin B	Other: Cytochalasin B use in ICSI handling medium; A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate
No Intervention: Handling Medium as it is.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oocyte survival rate	number of survived oocyte after intracytoplasmic sperm injection	6 days of culture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fertilization rate	number of fertilized oocytes per metaphase II injected	6 days of culture
blastocyst formation rate	number of formed blastocyst per fertilized oocyte	6 days of culture
embryo utilization rate	number of embryo transferred added to number of those cryopreserved per fertilized oocyte	6 days of culture
clinical pregnancy rate	number of women with a heartbeat at week 4 or more after embryo transfer	three months
ongoing pregnancy rate	number of women with continued pregnancy after twelve weeks of gestation	four months

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Collaborators: Banoon IVF Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2018
• Primary Completion (Actual): July 20, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IbnSinaIVF-ICSI-CB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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