Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)

Infertility Clinical Trial

Official title:

Latrunculin B Supplementation to ICSI Handling Medium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678597
• Other study ID #: IbnSinaIVF-ICSI-LB
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: May 2019
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Latrunculin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 30, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• All ICSI cycles

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Medium Supplemented with Latrunculin B
A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate

Locations

Country	Name	City	State
Egypt	Banon Assiut	Assiut
Egypt	Qena Fertility Center	Qena
Egypt	IbnSina IVF Center, IbnSina Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Ibn Sina Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oocyte survival rate after ICSI		6 days of culture
Secondary	Fertilisation rate		6 days of culture
Secondary	Rates of blastocyst formation and quality	Number of formed and high-quality blastocysts per fertilized oocytes	6 days of culture
Secondary	Clinical pregnancy rate		three months
Secondary	Implantation rate		7 weeks
Secondary	Ongoing pregnancy rate		12 weeks