Clinical trial NCT05113238: Oocyte Activation: Revised or Initial AGT Technique, Which is Better?! A Sibling-oocytes-split Design
Official title: Oocyte Activation: Revised or Initial Activated Gamete Treatment (AGT) Technique, Which is Better?! A Sibling-oocytes-split Design and Case Series of Chemical Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assisted Reproductive Technology
Keywords: Calcium ionophore
gamete activation
ICSI
male factor
Lead sponsor: Royal Fertility Center, Egypt
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2021-11-09
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: single group of patients will be conducted into sibling-oocyte-split design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of top quality day 3 embryos
timeFrame: 3 days after ICSI procedure day
measure: Number of Top quality day 4 embryos
timeFrame: 4 days after ICSI procedure
measure: Number of Top quality day 5 embryos
timeFrame: 5 days after ICSI procedure
Secondary outcomes:
measure: chemical pregnancy rate
timeFrame: 15 days after embryo transfer procedure day
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Royal Fertility Center
state: Daqahlya
Study officials:
affiliation: research team leader
name: Sahar SA Eissa, PHD
role: STUDY_DIRECTOR
affiliation: investigator & researcher
name: Engy EA Abdallah, M.sc
role: STUDY_CHAIR
References: