Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03677492
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site: 150
• Patients Per Site Per Month: 21

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Medium Supplemented with Cytochalasin D	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: Cytochalasin D Supplementation to ICSI Handling Medium
• Actual Study Start Date: Sep 25, 2018
• Actual Primary Completion Date: Apr 25, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Oocyte survival rate [6 days of culture]

Secondary Outcome Measures

1. Fertilization rate [6 days of culture]

2. Blastocyst formation rate [6 days of culture]

3. Embryo utilization rate [6 days of culture]

4. Clinical pregnancy rate [three months]

5. Implantation rate [7 weeks]

6. Ongoing pregnancy rate [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ICSI indicated participants

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon Assiut	Assiut		Egypt
2	IbnSina IVF Center, IbnSina Hospital	Sohag		Egypt	12345

Sponsors and Collaborators

• Ibn Sina Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT03677492
• Other Study ID Numbers: IbnSinaIVF-ICSI-CD
• First Posted: Sep 19, 2018
• Last Update Posted: May 7, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Cytochalasin D

Study Results

No Results Posted as of May 7, 2019