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

Not Applicable

Completed

• Conditions: Assisted Reproductive Technology

• Registration Number: NCT05113238
• Lead Sponsor: Royal Fertility Center, Egypt

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-08
• Study Start: 2021-10-15
• Study First Submitted QC: 2021-11-07
• Study First Posted: 2021-11-09
• Primary Completion: 2021-12-25
• Study Completion: 2021-12-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of top quality day 3 embryos	3 days after ICSI procedure day	number of top quality embryos
Number of Top quality day 4 embryos	4 days after ICSI procedure	number of top quality embryos
Number of Top quality day 5 embryos	5 days after ICSI procedure	number of top quality embryos

Secondary Outcome Measures

Name	Time	Method
chemical pregnancy rate	15 days after embryo transfer procedure day	the number of positive pregnancy cases from overall cases

Trial Locations

Locations (1)

Royal Fertility Center; 🇪🇬 Mansoura, Daqahlya, Egypt