Assisted Reproductive TechnologyNCT05113238
Oocyte Activation: Revised or Initial AGT Technique, Which is Better?! A Sibling-oocytes-split Design
A study testing Assisted gamete activation in people with Assisted Reproductive Technology, run by Royal Fertility Center, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Assisted Reproductive Technology
- What is being tested?
- Assisted gamete activation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- age >40 years
- BMI >34
- aspirated oocytes < 4
- Normozoospermia
- subfertile patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Assisted Reproductive Technology
- Being tested
- Assisted gamete activation
- Keywords
- Calcium ionophore, gamete activation, ICSI, male factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted gamete activationProcedure or surgery
compare two different assisted gamete activation protocols to improve ICSI outcome
| Study group | Role | What they receive |
|---|---|---|
| AGT-Initial | Active comparator | 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. Receives: Procedure: Assisted gamete activation |
| AGT-revised | Experimental | 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. Receives: Procedure: Assisted gamete activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of top quality day 3 embryos
number of top quality embryos
Measured: 3 days after ICSI procedure day
Number of Top quality day 4 embryos
number of top quality embryos
Measured: 4 days after ICSI procedure
Number of Top quality day 5 embryos
number of top quality embryos
Measured: 5 days after ICSI procedure
Secondary outcomes (1)
chemical pregnancy rate
the number of positive pregnancy cases from overall cases
Measured: 15 days after embryo transfer procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Oct 2021
- Primary completion25 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- single group of patients will be conducted into sibling-oocyte-split design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Fertility Center, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Sponsor
- Investigators
- Sahar SA Eissa, PHD, Study director, research team leaderEngy EA Abdallah, M.sc, Study chair, investigator & researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113238
- Sponsor's protocol ID
- 003
- Status last verified
- Sep 2022
- First submitted
- 8 Oct 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and outcome
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05113238
- Acronym / sponsor ID
- 003
- Conditions
- Assisted Reproductive Technology
- Keywords
- Calcium ionophore, gamete activation, ICSI, male factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Royal Fertility Center, EgyptUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- single group of patients will be conducted into sibling-oocyte-split design
| Arm | Type | Receives |
|---|---|---|
| AGT-Initial | Active comparator | Procedure: Assisted gamete activationOocytes 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 | Experimental | Procedure: Assisted gamete activationejaculated 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- age >40 years
- BMI >34
- aspirated oocytes < 4
- Normozoospermia
- subfertile patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted gamete activationcompare two different assisted gamete activation protocols to improve ICSI outcome | Procedure or surgery | AGT-Initial, AGT-revised |
Primary outcome
Number of top quality day 3 embryos
Time frame: 3 days after ICSI procedure day
number of top quality embryos
Number of Top quality day 4 embryos
Time frame: 4 days after ICSI procedure
number of top quality embryos
Number of Top quality day 5 embryos
Time frame: 5 days after ICSI procedure
number of top quality embryos
1 secondary outcome
chemical pregnancy rate
Time frame: 15 days after embryo transfer procedure day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes. study protocol and outcome
Related trials for Assisted Reproductive Technology
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Not yet recruitingObservational study
Low TGF-β and Embryo Implantation in the Context of Assisted Reproductive Technology: Confirmation of a Biomarker Predictive of Success and Characterization of the Immune Microenvironment.
Infertility, Female, Pregnancy Related
Not yet recruitingObservational study
Association Between Serum Progesterone Levels on Embryo Transfer Day and Clinical Pregnancy in Frozen-thawed Embryo Transfer Cycles Using Hormone Replacement Therapy
Infertility Assisted Reproductive Technology
RecruitingObservational study
Machine-Learning Prediction of Pregnancy Outcomes After Assisted Reproductive Treatments
IVF Outcomes, Prediction Models
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar SA Eissa, PHD study director
research team leader
Engy EA Abdallah, M.sc study chair
investigator & researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted gamete activation in people with Assisted Reproductive Technology, run by Royal Fertility Center, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of top quality day 3 embryos (time frame: 3 days after ICSI procedure day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.