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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cytochalasin B use in ICSI handling medium
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All ICSI candidates patients

Exclusion Criteria:

  • No exclusion

Sites / Locations

  • IbnSina IVF Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Handling Medium Supplemented with Cytochalasin B

Handling Medium as it is.

Arm Description

Outcomes

Primary Outcome Measures

oocyte survival rate
number of survived oocyte after intracytoplasmic sperm injection

Secondary Outcome Measures

fertilization rate
number of fertilized oocytes per metaphase II injected
blastocyst formation rate
number of formed blastocyst per fertilized oocyte
embryo utilization rate
number of embryo transferred added to number of those cryopreserved per fertilized oocyte
clinical pregnancy rate
number of women with a heartbeat at week 4 or more after embryo transfer
ongoing pregnancy rate
number of women with continued pregnancy after twelve weeks of gestation

Full Information

First Posted
September 6, 2018
Last Updated
August 5, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center
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1. Study Identification

Unique Protocol Identification Number
NCT03663634
Brief Title
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B
Acronym
ICSI-CB
Official Title
Cytochalasin B Supplementation to ICSI Handling Medium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 16, 2018 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
987 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handling Medium Supplemented with Cytochalasin B
Arm Type
Experimental
Arm Title
Handling Medium as it is.
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cytochalasin B use in ICSI handling medium
Intervention Description
A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate
Primary Outcome Measure Information:
Title
oocyte survival rate
Description
number of survived oocyte after intracytoplasmic sperm injection
Time Frame
6 days of culture
Secondary Outcome Measure Information:
Title
fertilization rate
Description
number of fertilized oocytes per metaphase II injected
Time Frame
6 days of culture
Title
blastocyst formation rate
Description
number of formed blastocyst per fertilized oocyte
Time Frame
6 days of culture
Title
embryo utilization rate
Description
number of embryo transferred added to number of those cryopreserved per fertilized oocyte
Time Frame
6 days of culture
Title
clinical pregnancy rate
Description
number of women with a heartbeat at week 4 or more after embryo transfer
Time Frame
three months
Title
ongoing pregnancy rate
Description
number of women with continued pregnancy after twelve weeks of gestation
Time Frame
four months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All ICSI candidates patients Exclusion Criteria: No exclusion
Facility Information:
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B

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