search
Back to results

Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Medium Supplemented with Chaetoglobosin A
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All ICSI participants agreed

Exclusion Criteria:

-

Sites / Locations

  • Banon Assiut
  • Qena Fertility Center
  • IbnSina IVF Center, IbnSina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Handling Medium Supplemented with Chaetoglobosin A

handling Medium as it is.

Arm Description

Outcomes

Primary Outcome Measures

Oocyte Survival after ICSI
Survived oocytes per MII injected

Secondary Outcome Measures

Fertilization rate
Rate of top-quality embryo
Rate of top-quality embryo per fertilized oocytes
blastocyst formation and quality
Number of formed blastocyst and high-quality blastocyst per fertilized oocytes
blastocyst utilization rate
Number of transferred and vitrified embryos per fertilized oocytes
clinical pregnancy rate
Number of pregnant women per recruited cycles
Implantation rate
sacs with a heartbeat per embryo transferred
Ongoing pregnancy rate

Full Information

First Posted
September 17, 2018
Last Updated
May 5, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Qena Fertility Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03678584
Brief Title
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
Official Title
Chaetoglobosin A Supplementation to ICSI Handling Medium
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Qena Fertility 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. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A 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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handling Medium Supplemented with Chaetoglobosin A
Arm Type
Experimental
Arm Title
handling Medium as it is.
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Medium Supplemented with Chaetoglobosin A
Intervention Description
A medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate
Primary Outcome Measure Information:
Title
Oocyte Survival after ICSI
Description
Survived oocytes per MII injected
Time Frame
two days
Secondary Outcome Measure Information:
Title
Fertilization rate
Time Frame
6 days of culture
Title
Rate of top-quality embryo
Description
Rate of top-quality embryo per fertilized oocytes
Time Frame
6 days of culture
Title
blastocyst formation and quality
Description
Number of formed blastocyst and high-quality blastocyst per fertilized oocytes
Time Frame
6 days of culture
Title
blastocyst utilization rate
Description
Number of transferred and vitrified embryos per fertilized oocytes
Time Frame
6 days of culture
Title
clinical pregnancy rate
Description
Number of pregnant women per recruited cycles
Time Frame
7 weeks
Title
Implantation rate
Description
sacs with a heartbeat per embryo transferred
Time Frame
7 weeks
Title
Ongoing pregnancy rate
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All ICSI participants agreed Exclusion Criteria: -
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)

We'll reach out to this number within 24 hrs