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

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

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

Study Overview

• Status: Completed
• Conditions: Assisted Reproductive Technology
• Intervention / Treatment: Procedure: Assisted gamete activation

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 Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Daqahlya
    • Mansoura, Daqahlya, Egypt, 35511
      • Royal Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AGT-Initial; Oocytes will be injected with spermatozoa and 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.	Procedure: Assisted gamete activation; compare two different assisted gamete activation protocols to improve ICSI outcome
Experimental: AGT-revised; 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 PVP drop. Next, approximately 0.4 pL of calcium ionophore will be aspirated into the micropipette and injected into the oocyte with the spermatozoa. Post-ICSI oocytes will be then exposed to 50 mM calcium ionophore for 10 minutes at 37C, and then will be washed and placed in culture medium.	Procedure: Assisted gamete activation; compare two different assisted gamete activation protocols to improve ICSI outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of top quality day 3 embryos	number of top quality embryos	3 days after ICSI procedure day
Number of Top quality day 4 embryos	number of top quality embryos	4 days after ICSI procedure
Number of Top quality day 5 embryos	number of top quality embryos	5 days after ICSI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical pregnancy rate	the number of positive pregnancy cases from overall cases	15 days after embryo transfer procedure day

Collaborators and Investigators

• Sponsor: Royal Fertility Center, Egypt
• Collaborators: Hawaa Fertility Center
• Investigators: Study Director: Sahar SA Eissa, PHD, research team leader; Study Chair: Engy EA Abdallah, M.sc, investigator & researcher

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Calcium ionophore; ICSI; male factor; gamete activation
• Other Study ID Numbers: 003 (033)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol and outcome
• IPD Sharing Time Frame: two months
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No