FertilizationNCT04519918
Clinical Application of Artificial Oocyte Activation Technique (AOA) in ART
A study testing AOA in people with Fertilization, run by Tang-Du Hospital at 1 site in China.
Trial summary
Oocyte activation is an imperative stage in the initiation of embryo development during the fertilization. Indeed, the entrance of sperm into the oocyte causes sequences of calcium oscillations in its cytoplasm, regulating a series of molecular events called oocyte activation. Read more about this study
- Who is it for?
- Ages 22 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertilization
- What is being tested?
- AOA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Aug 2022
- 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 22 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients suffered at least one complete fertilization failure or low fertilization rate after performing standard ICSI in previous cycle. Low fertilization was defined as less than 33% fertilization rate.
- The patients suffered at least 2 cycles complete fertilization failure or low fertilization rate after performing IVF in previous cycle. Low fertilization was defined as less than 33% fertilization rate.
- The sperm of the patients has the following characteristics: globozoospermia, acrosomal deletion or small, severe head deformity, etc.
- Sperm of testicular origin and/or sperm that has been freeze-thawed.
- The sperm was PLC-ζ missing.
- The MII oocytes were IVM cultured and/or freeze-thawed.
- The patients suffered at least 2 cycles no available embryos, because of the embryo development block or fragmentation.
Who cannot join
- Normal fertilization IVF/ICSI cycles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Application of Artificial Oocyte Activation Technique (AOA) in Assisted Reproduction Technology
Oocyte activation is an imperative stage in the initiation of embryo development during the fertilization. Indeed, the entrance of sperm into the oocyte causes sequences of calcium oscillations in its cytoplasm, regulating a series of molecular events called oocyte activation. The intracytoplasmic sperm injection (ICSI) has allowed fertilization in couples with severe male factor infertility. But, there was still fertilization failure or low fertilization occurs in ICSI cycles. It has reported that insufficient of oocyte activation is the important cause of fertilization failure. Artificial oocyte activation (AOA) represents an effective technique, can restore the calcium oscillations to improve the fertilization. Here, the investigators explore the effective of different AOA methods including oocyte was injected CaCl2 or mechanical stimulated then treated with calcium ionophore.
Read the detailed description
The ICSI procedure improves fertilization rates in cases of male factor infertility. However, fertilization failure still occurs in 1-5% in ICSI cycles. The main cause of failed fertilization is failure to complete oocyte activation. Oocyte activation involves a multitude of molecular changes. The investigators use a variety of mechanical, electrical, and chemical methods to trigger the calcium oscillations necessary to activate oocytes. During mechanical activation of oocytes, oolemmas are pierced using a microneedle to trigger a calcium influx. Another method for mechanical oocyte activation is the direct microinjection of calcium into the oocyte to increase intracellular calcium. It has been described with the use of calcium ionophore A23187, which can mimic the natural pattern of calcium rise. Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation, can mimic calcium oscillations resulting in successful fertilization. AOA, a highly specialized fertilization technique that can be added to conventional ICSI to overcome fertilization failure in patients that had failed fertilization or poor quality embryos history.
When the number of retrieved oocytes was >10, sibling oocytes were divided into 3 groups to perform the standard ICSI procedure (control group), chemical AOA (A1 experiment group) or mechanical AOA (A2 experiment group). When the number of retrieved oocytes was 6-10, sibling oocytes were randomized 1:1 to perform the chemical AOA (A1 experiment group) or mechanical AOA (A2 experiment group). The number of retrieved oocytes was 1-5, all oocytes were perform the chemical AOA. Control group, a single spermatozoon was injected into the ooplasm, standard ICSI procedure. A1 experiment group, were treated by injecting CaCl2 concurrently with ICSI followed by sequential exposure of calcium ionophore A23187 activation solution for two times of post-ICSI AOA. A2 experiment group, mechanical stimulation was done before standard ICSI procedure, then the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA. The investigators want to establish the effective and safe of different AOA methods, to improve the fertilization outcome and embryo quality, and finally obtain healthy offspring.
- Conditions
- Fertilization
- Being tested
- AOA
- Keywords
- Fertilization failure, Artificial Oocyte Activation (AOA), Calcium ionophore, Fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOABehavioural
AOA represents an invasive non-physiological technique.
| Study group | Role | What they receive |
|---|---|---|
| Standard ICSI procedure | No intervention | a single spermatozoon was injected into the ooplasm. |
| Chemical oocyte activation | Experimental | After CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA. Receives: Behavioral: AOA |
| Mechanical oocyte activation | Experimental | Mechanical stimulation was done before standard ICSI procedure, then the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA. Receives: Behavioral: AOA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of AOA on fertilization
Assess the normal fertilization rate (2PN rate)
Measured: 12 months
Secondary outcomes (2)
Efficacy of AOA on embryo quality
Assess the good-quality embryo rate
Measured: 12 months
Efficacy of AOA on clinical outcome
Assess the live-birth rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2022 (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.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- 400 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
- NCT04519918
- Sponsor's protocol ID
- AOA
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 1 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 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Artificial Oocyte Activation Technique (AOA) in Assisted Reproduction Technology
- ClinicalTrials.gov ID
- NCT04519918
- Acronym / sponsor ID
- AOA
- Conditions
- Fertilization
- Keywords
- Fertilization failure, Artificial Oocyte Activation (AOA), Calcium ionophore, Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 20 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.
Oocyte activation is an imperative stage in the initiation of embryo development during the fertilization. Indeed, the entrance of sperm into the oocyte causes sequences of calcium oscillations in its cytoplasm, regulating a series of molecular events called oocyte activation. The intracytoplasmic sperm injection (ICSI) has allowed fertilization in couples with severe male factor infertility. But, there was still fertilization failure or low fertilization occurs in ICSI cycles. It has reported that insufficient of oocyte activation is the important cause of fertilization failure. Artificial oocyte activation (AOA) represents an effective technique, can restore the calcium oscillations to improve the fertilization. Here, the investigators explore the effective of different AOA methods including oocyte was injected CaCl2 or mechanical stimulated then treated with calcium ionophore.
Detailed description
The ICSI procedure improves fertilization rates in cases of male factor infertility. However, fertilization failure still occurs in 1-5% in ICSI cycles. The main cause of failed fertilization is failure to complete oocyte activation. Oocyte activation involves a multitude of molecular changes. The investigators use a variety of mechanical, electrical, and chemical methods to trigger the calcium oscillations necessary to activate oocytes. During mechanical activation of oocytes, oolemmas are pierced using a microneedle to trigger a calcium influx. Another method for mechanical oocyte activation is the direct microinjection of calcium into the oocyte to increase intracellular calcium. It has been described with the use of calcium ionophore A23187, which can mimic the natural pattern of calcium rise. Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation, can mimic calcium oscillations resulting in successful fertilization. AOA, a highly specialized fertilization technique that can be added to conventional ICSI to overcome fertilization failure in patients that had failed fertilization or poor quality embryos history.
When the number of retrieved oocytes was >10, sibling oocytes were divided into 3 groups to perform the standard ICSI procedure (control group), chemical AOA (A1 experiment group) or mechanical AOA (A2 experiment group). When the number of retrieved oocytes was 6-10, sibling oocytes were randomized 1:1 to perform the chemical AOA (A1 experiment group) or mechanical AOA (A2 experiment group). The number of retrieved oocytes was 1-5, all oocytes were perform the chemical AOA. Control group, a single spermatozoon was injected into the ooplasm, standard ICSI procedure. A1 experiment group, were treated by injecting CaCl2 concurrently with ICSI followed by sequential exposure of calcium ionophore A23187 activation solution for two times of post-ICSI AOA. A2 experiment group, mechanical stimulation was done before standard ICSI procedure, then the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA. The investigators want to establish the effective and safe of different AOA methods, to improve the fertilization outcome and embryo quality, and finally obtain healthy offspring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ICSI procedure | No intervention | –a single spermatozoon was injected into the ooplasm. |
| Chemical oocyte activation | Experimental | Behavioral: AOAAfter CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA. |
| Mechanical oocyte activation | Experimental | Behavioral: AOAMechanical stimulation was done before standard ICSI procedure, then the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patients suffered at least one complete fertilization failure or low fertilization rate after performing standard ICSI in previous cycle. Low fertilization was defined as less than 33% fertilization rate.
- The patients suffered at least 2 cycles complete fertilization failure or low fertilization rate after performing IVF in previous cycle. Low fertilization was defined as less than 33% fertilization rate.
- The sperm of the patients has the following characteristics: globozoospermia, acrosomal deletion or small, severe head deformity, etc.
- Sperm of testicular origin and/or sperm that has been freeze-thawed.
- The sperm was PLC-ζ missing.
Key exclusion criteria (1 listed)
- Normal fertilization IVF/ICSI cycles.
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 |
|---|---|---|
| AOAAOA represents an invasive non-physiological technique. | Behavioural | Chemical oocyte activation, Mechanical oocyte activation |
Primary outcome
Efficacy of AOA on fertilization
Time frame: 12 months
Assess the normal fertilization rate (2PN rate)
2 secondary outcomes
Efficacy of AOA on embryo quality
Time frame: 12 months
Efficacy of AOA on clinical outcome
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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 AOA 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 7 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 1 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?
Efficacy of AOA on fertilization (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 1 Sep 2020.