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

NCT05113238 | Completed DMC

• 1 other identifier: 003
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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

Conditions

Assisted Reproductive Technology

Keywords

Calcium ionophore; gamete activation; ICSI; male factor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• chemical pregnancy rate

  15 days after embryo transfer procedure day

Study Arms (2)

AGT-Initial

ACTIVE COMPARATOR

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

AGT-revised

EXPERIMENTAL

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

Interventions

Assisted gamete activation PROCEDURE

compare two different assisted gamete activation protocols to improve ICSI outcome

AGT-Initial; AGT-revised

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• age \>40 years
• BMI \>34
• aspirated oocytes \< 4
• Normozoospermia
• subfertile patients

Sponsors & Collaborators

• Royal Fertility Center, Egypt: lead
• Hawaa Fertility Center: collaborator

Study Sites (1)

Royal Fertility Center

Al Mansurah, Daqahlya, 35511, Egypt

Location

Study Officials

• Sahar SA Eissa, PHD

  research team leader

  STUDY DIRECTOR

• Engy EA Abdallah, M.sc

  investigator & researcher

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group of patients will be conducted into sibling-oocyte-split design

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 9, 2021
• Study Start: October 15, 2021
• Primary Completion: December 25, 2021
• Study Completion: December 30, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: two months

Locations

EG (1)