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

Royal Fertility Center, Egypt

Status: Completed

Conditions: Assisted Reproductive Technology

Treatments: Procedure: Assisted gamete activation

Study type: Interventional

Funder types: Other

Identifiers

NCT05113238

003

Details and patient eligibility

About

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

Full 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.

Enrollment: 222 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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222 participants in 2 patient groups

AGT-Initial

Active Comparator group

Description:

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.

Treatment:

Procedure: Assisted gamete activation

AGT-revised

Experimental group

Description:

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.

Treatment:

Procedure: Assisted gamete activation