Oocyte Activation: Revised or Initial AGT Technique, Which is Better?! A Sibling-oocytes-split Design

Assisted Reproductive Technology Clinical Trial

Official title:

Oocyte Activation: Revised or Initial Activated Gamete Treatment (AGT) Technique, Which is Better?! A Sibling-oocytes-split Design and Case Series of Chemical Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113238
• Other study ID #: 003
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2022
• Source: Royal Fertility Center, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to compare two different Assisted Gamete treatment (AGT) with oocyte-sibling-split design control group : AGT- initial protocol for activating oocytes by culturing oocytes in calcium ionophore after injection for two rounds of 10 minutes at 37 C, 30 minutes after injection.

sample group : AGT-revised protocol oocytes will be injected by sperm previously cultured in Ca ionophore and 0.4 pL of calcium ionophore then will be cultured in calcium ionophore after injection for 10 minutes

Description:

investigators performed ICSI then with one of two activation protocols added : AGT-initial or AGT-revised For the AGT initial protocol, Oocytes will be injected then will be incubated in 10 mM calcium ionophore (Sigma-Aldrich) for two rounds of 10 minutes at 37 C, 30 minutes after ICSI injection, and then will be rinsed and transferred into culture medium.

For the AGT-revised protocol, ejaculated spermatozoa will be exposed to calcium ionophore in a drop on the ICSI dish before injection. During the ICSI procedure, spermatozoa will be aspirated individually from the drop containing calcium ionophore and immobilized in a separate polyvinylpyrrolidone drop. Next, approximately 0.4 pL of calcium ionophore will be aspirated into the micropipette and will be injected into the oocyte with the spermatozoa. Post-ICSI oocytes will be then exposed to 50 mM calcium ionophore for 10 minutes at 37 C, and then will be washed and placed in culture medium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 30, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• couples presented with an extremely poor fertilization (<10%)

• couples with previous complete fertilization failure after undergoing ICSI cycles

• At least 4 MII oocytes

• Severe oligoasthinozoospermia

• Teratozoospermia

• testicular aspirated sperm

Exclusion Criteria:

• age >40 years

• BMI >34

• aspirated oocytes < 4

• Normozoospermia

• subfertile patients

Related Conditions & MeSH terms

• Assisted Reproductive Technology

Intervention

Procedure:
• Assisted gamete activation
compare two different assisted gamete activation protocols to improve ICSI outcome

Locations

Country	Name	City	State
Egypt	Royal Fertility Center	Mansoura	Daqahlya

Sponsors (2)

Lead Sponsor	Collaborator
Royal Fertility Center, Egypt	Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of top quality day 3 embryos	number of top quality embryos	3 days after ICSI procedure day
Primary	Number of Top quality day 4 embryos	number of top quality embryos	4 days after ICSI procedure
Primary	Number of Top quality day 5 embryos	number of top quality embryos	5 days after ICSI procedure
Secondary	chemical pregnancy rate	the number of positive pregnancy cases from overall cases	15 days after embryo transfer procedure day