FertilizationNCT04523103
Artificial Assisted Activation Following in Fertilization Failure
A study testing Artificial Assisted Activation in people with Fertilization, run by Tang-Du Hospital at 1 site in China.
Trial summary
Fertilization failure is a common problem in assisted reproductive Technology (ART). The main reason for fertilization failure of conventional IVF fertilization is sperm penetration failure, and the main reason of ICSI is insufficient oocyte activation. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertilization
- What is being tested?
- Artificial Assisted Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Sep 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 8 ≤ Number of retrieved oocytes ≤ 20;
- 18.5< Body Mass Index (BMI) <25;
- The patients who suffered complete fertilization failure or low fertilization after performing standard ICSI/IVF cycle. Low fertilization was defined as less than 33% fertilization rate.
Who cannot join
- Normal fertilization IVF/ICSI cycle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Artificial Assisted Oocyte Activation Technique in IVF Fertilization Failure
Fertilization failure is a common problem in assisted reproductive Technology (ART). The main reason for fertilization failure of conventional IVF fertilization is sperm penetration failure, and the main reason of ICSI is insufficient oocyte activation. Artificial assisted activation may provide an effective technique to rescue fertilization failure. In this study, standard ICSI procedures were applied to save fertilization failure of unfertilized mature oocytes in IVF cycles. The unfertilized mature oocytes after ICSI were activated by calcium ion, or injected with calcium chloride/activated with mechanical stimulated and then transfer to calcium ion to improve fertilization. In this study, different artificial assisted activation methods were used to save the fertilization failure and assess its effective and subsequent embryo development potential.
Read the detailed description
A variety of mechanical, electrical, and chemical methods has been used to trigger the calcium oscillations to activate oocytes. Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation, which can mimic calcium oscillations saving fertilization failure.
Control group, a single spermatozoon was injected into the failed fertilization MII oocyte in conventional IVF cycle. What to do when ICSI fails? The investigators collected the unfertilized MII oocytes and divided them into 3 groups to perform different activation methods, including chemical calcium ionophore activation (experiment group 1), CaCl2 injected combined with calcium ionophore activation (experiment group 2), and mechanical stimulation combined with calcium ionophore activation (experiment group 3). Calcium ionophore A23187 (Sigma) was used for assisted activation. The final solution was 10 μmol/L. The oocytes were exposed to the calcium ionophore A23187 for 10 min at 37°C in 5% CO2. The oocytes were checked for pronucleus formation at 16-20 hours after activation. Fertilized oocytes were cultured in vitro for 3-5 days, the developmental potential of the activated embryos were observed.
This study want to explore the effective of different artificial assisted activation methods, to improve the fertilization outcome of unfertilized oocytes after ICSI or IVF.
- Conditions
- Fertilization
- Being tested
- Artificial Assisted Activation
- Keywords
- fertilization failure, oocyte activation, calcium ionophore
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Assisted ActivationBehavioural
Artificial assisted activation represents an effective technique to rescue the fertilization failure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard ICSI procedure. The MII oocytes that failed fertilization in IVF cycles were injected with activating sperm. |
| A1 assisted activation | Experimental | The MII oocytes that failed fertilization in ICSI cycles were activated in calcium ionophore A23187 activation solution for two times. Receives: Behavioral: Artificial Assisted Activation |
| A2 assisted activation | Experimental | Fertilization failure MII oocytes were collected in ICSI cycles. After CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 solution for two times. Receives: Behavioral: Artificial Assisted Activation |
| A3 assisted activation | Experimental | Fertilization failure MII oocytes were collected in ICSI cycles. Mechanical activation was done for the MII oocytes, and then the oocytes were transferred into the calcium ionophore A23187 solution for two times. Receives: Behavioral: Artificial Assisted Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the normal fertilization rate
Fertilization (2PN rate)
Measured: 12 months
Secondary outcomes (3)
the good-quality embryo rate
Embryo quality
Measured: 12 months
the blastocyst formation rate
Embryo quality
Measured: 12 months
the good quality blastocyst rate
Embryo quality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilizationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Bo, Doctor, Study chair, Reproductive Medicine Center, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523103
- Sponsor's protocol ID
- A0728
- Status last verified
- Sep 2020
- First submitted
- 19 Aug 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Artificial Assisted Oocyte Activation Technique in IVF Fertilization Failure
- ClinicalTrials.gov ID
- NCT04523103
- Acronym / sponsor ID
- A0728
- Conditions
- Fertilization
- Keywords
- fertilization failure, oocyte activation, calcium ionophore
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 21 Aug 2020 (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.
Fertilization failure is a common problem in assisted reproductive Technology (ART). The main reason for fertilization failure of conventional IVF fertilization is sperm penetration failure, and the main reason of ICSI is insufficient oocyte activation. Artificial assisted activation may provide an effective technique to rescue fertilization failure. In this study, standard ICSI procedures were applied to save fertilization failure of unfertilized mature oocytes in IVF cycles. The unfertilized mature oocytes after ICSI were activated by calcium ion, or injected with calcium chloride/activated with mechanical stimulated and then transfer to calcium ion to improve fertilization. In this study, different artificial assisted activation methods were used to save the fertilization failure and assess its effective and subsequent embryo development potential.
Detailed description
A variety of mechanical, electrical, and chemical methods has been used to trigger the calcium oscillations to activate oocytes. Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation, which can mimic calcium oscillations saving fertilization failure.
Control group, a single spermatozoon was injected into the failed fertilization MII oocyte in conventional IVF cycle. What to do when ICSI fails? The investigators collected the unfertilized MII oocytes and divided them into 3 groups to perform different activation methods, including chemical calcium ionophore activation (experiment group 1), CaCl2 injected combined with calcium ionophore activation (experiment group 2), and mechanical stimulation combined with calcium ionophore activation (experiment group 3). Calcium ionophore A23187 (Sigma) was used for assisted activation. The final solution was 10 μmol/L. The oocytes were exposed to the calcium ionophore A23187 for 10 min at 37°C in 5% CO2. The oocytes were checked for pronucleus formation at 16-20 hours after activation. Fertilized oocytes were cultured in vitro for 3-5 days, the developmental potential of the activated embryos were observed.
This study want to explore the effective of different artificial assisted activation methods, to improve the fertilization outcome of unfertilized oocytes after ICSI or IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard ICSI procedure. The MII oocytes that failed fertilization in IVF cycles were injected with activating sperm. |
| A1 assisted activation | Experimental | Behavioral: Artificial Assisted ActivationThe MII oocytes that failed fertilization in ICSI cycles were activated in calcium ionophore A23187 activation solution for two times. |
| A2 assisted activation | Experimental | Behavioral: Artificial Assisted ActivationFertilization failure MII oocytes were collected in ICSI cycles. After CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 solution for two times. |
| A3 assisted activation | Experimental | Behavioral: Artificial Assisted ActivationFertilization failure MII oocytes were collected in ICSI cycles. Mechanical activation was done for the MII oocytes, and then the oocytes were transferred into the calcium ionophore A23187 solution for two times. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 8 ≤ Number of retrieved oocytes ≤ 20;
- 18.5< Body Mass Index (BMI) <25;
- The patients who suffered complete fertilization failure or low fertilization after performing standard ICSI/IVF cycle. Low fertilization was defined as less than 33% fertilization rate.
Key exclusion criteria (1 listed)
- Normal fertilization IVF/ICSI cycle.
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 |
|---|---|---|
| Artificial Assisted ActivationArtificial assisted activation represents an effective technique to rescue the fertilization failure. | Behavioural | A1 assisted activation, A2 assisted activation, A3 assisted activation |
Primary outcome
the normal fertilization rate
Time frame: 12 months
Fertilization (2PN rate)
3 secondary outcomes
the good-quality embryo rate
Time frame: 12 months
the blastocyst formation rate
Time frame: 12 months
the good quality blastocyst rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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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.
Li Bo, Doctor study chair
Reproductive Medicine Center, Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Assisted Activation in people with Fertilization, run by Tang-Du Hospital at 1 site in China.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Sep 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Ming, Master (8613259809290, wangmingbio@snnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the normal fertilization rate (time frame: 12 months). 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 18 Sep 2020.