Oocyte Activation: Revised or Initial AGT Technique, Which is Better?! A Sibling-oocytes-split Design
- Conditions
- Assisted Reproductive Technology
- Interventions
- Procedure: Assisted gamete activation
- Registration Number
- NCT05113238
- Lead Sponsor
- Royal Fertility Center, Egypt
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- 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
- age >40 years
- BMI >34
- aspirated oocytes < 4
- Normozoospermia
- subfertile patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AGT-Initial Assisted gamete activation 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. AGT-revised Assisted gamete activation 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method chemical pregnancy rate 15 days after embryo transfer procedure day the number of positive pregnancy cases from overall cases
Trial Locations
- Locations (1)
Royal Fertility Center
🇪🇬Mansoura, Daqahlya, Egypt