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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05113238

Enrollment

222

Registered

2021-11-09

Start date

2021-10-15

Completion date

2021-12-30

Last updated

2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assisted Reproductive Technology

Keywords

Calcium ionophore, gamete activation, ICSI, male factor

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.

Interventions

PROCEDUREAssisted gamete activation

compare two different assisted gamete activation protocols to improve ICSI outcome

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026