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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2021-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Assisted Reproductive Technology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Assisted gamete activation

Intervention Type PROCEDURE

compare two different assisted gamete activation protocols to improve ICSI outcome

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.

Group Type EXPERIMENTAL

Assisted gamete activation

Intervention Type PROCEDURE

compare two different assisted gamete activation protocols to improve ICSI outcome

Interventions

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Assisted gamete activation

compare two different assisted gamete activation protocols to improve ICSI outcome

Intervention Type PROCEDURE

Eligibility Criteria

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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