Infertility, FemaleNCT06459778
Piezo-ICSI to Improve the Developmental Potential of Fertilized Oocytes in Aged Infertility Women With Assisted Reproductive Technology
A study testing Piezo-ICSI in people with Infertility, Female and Intracytoplasmic Sperm Injections, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection (ICSI). The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility, Female, Intracytoplasmic Sperm Injections
- What is being tested?
- Piezo-ICSI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to May 2026
- 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 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 35 years ≤ age ≤ 42 years;
- Number of IVF/ICSI cycles ≤ 2
Who cannot join
- Egg donor cycle
- Chromosome abnormality;
- Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
- Patients with repeated implantation failure
Trial locations and contacts
1 site in 1 country.
Jie D Mei, MD contact
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Haixiang Sun, 025-83107188, stevensunz@163.com
About this study
Official title: A Single-center Randomized Controlled Trial on Piezo-ICSI Improving Oocyte Fertilization and Embryo Development in Elderly Infertile Patients
The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection (ICSI). The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development. Participants requested ICSI are asked to randomly culture equal numbers of oocyte and embryo with or without Piezo-ICSI. At the time of injection, two or more mature oocytes were split into two groups (i) conventional ICSI and (ii) Piezo-ICSI (50:50 split).
Read the detailed description
After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study compare different ICSI methods on the fertilization and embryo development. Sibling oocytes were randomly divided into test group (Piezo-ICSI) and control group (conventional ICSI).
Specific method of randomization: all the oocytes of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were fertilized with Piezo-ICSI, while the control oocytes were fertilized with conventional ICSI.
Thus, half of the oocytes from each elderly infertile patient were treated with Piezo-ICSI.
- Being tested
- Piezo-ICSI
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezo-ICSIDevice
Participants had their oocytes cohort divided, where half were injected using conventional ICSI and the other half were injected using Piezo-ICSI.
| Study group | Role | What they receive |
|---|---|---|
| Piezo-ICSI group, Oocytes in this group will be fertilized with Piezo-ICSI | Experimental | The Piezo-ICSI technique involves the use a piezoelectric actuator to create high speed movement of the injection pipette. These fine movements allow precise microdrilling of the zona and smooth penetration of injection pipette into the cytoplasm and a single Piezo pulse facilitates breakage of the membrane, with the spermatozoa deposited into the cytoplasm without the need for cytoplasmic aspiration or agitation. Since the initial reports of the use of Piezo-ICSI in human oocytes, there have been notable improvements made to the technique, including a change in the operating fluid, leading to a safe and effective technique suitable for clinical use. In addition, when this technology was utilized in patients with poor outcomes, including low fertilization, high degeneration or low utilization in previous cycles, it resulted in improved fertilization, degeneration, embryo utilization and pregnancy rates compared with conventional ICSI. Receives: Device: Piezo-ICSI |
| Control group, Oocytes in this group will be fertilized with conventional ICSI | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate post intracytoplasmic sperm injection
The primary outcome measure was the fertilization rate 16-18 hours post intracytoplasmic sperm injection
Measured: 16-18 hours post intracytoplasmic sperm injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 Nov 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shanshan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459778
- Sponsor's protocol ID
- SZ-Piezo-1
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Trial on Piezo-ICSI Improving Oocyte Fertilization and Embryo Development in Elderly Infertile Patients
- ClinicalTrials.gov ID
- NCT06459778
- Acronym / sponsor ID
- SZ-Piezo-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 14 Jun 2024 (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.
The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection (ICSI). The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development. Participants requested ICSI are asked to randomly culture equal numbers of oocyte and embryo with or without Piezo-ICSI. At the time of injection, two or more mature oocytes were split into two groups (i) conventional ICSI and (ii) Piezo-ICSI (50:50 split).
Detailed description
After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study compare different ICSI methods on the fertilization and embryo development. Sibling oocytes were randomly divided into test group (Piezo-ICSI) and control group (conventional ICSI).
Specific method of randomization: all the oocytes of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were fertilized with Piezo-ICSI, while the control oocytes were fertilized with conventional ICSI.
Thus, half of the oocytes from each elderly infertile patient were treated with Piezo-ICSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezo-ICSI group, Oocytes in this group will be fertilized with Piezo-ICSI | Experimental | Device: Piezo-ICSIThe Piezo-ICSI technique involves the use a piezoelectric actuator to create high speed movement of the injection pipette. These fine movements allow precise microdrilling of the zona and smooth penetration of injection pipette into the cytoplasm and a single Piezo pulse facilitates breakage of the membrane, with the spermatozoa deposited into the cytoplasm without the need for cytoplasmic aspiration or agitation. Since the initial reports of the use of Piezo-ICSI in human oocytes, there have been notable improvements made to the technique, including a change in the operating fluid, leading to a safe and effective technique suitable for clinical use. In addition, when this technology was utilized in patients with poor outcomes, including low fertilization, high degeneration or low utilization in previous cycles, it resulted in improved fertilization, degeneration, embryo utilization and pregnancy rates compared with conventional ICSI. |
| Control group, Oocytes in this group will be fertilized with conventional ICSI | No intervention | – |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 35 years ≤ age ≤ 42 years;
- Number of IVF/ICSI cycles ≤ 2
Key exclusion criteria (4 listed)
- Egg donor cycle
- Chromosome abnormality;
- Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
- Patients with repeated implantation failure
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 |
|---|---|---|
| Piezo-ICSIParticipants had their oocytes cohort divided, where half were injected using conventional ICSI and the other half were injected using Piezo-ICSI. | Device | Piezo-ICSI group, Oocytes in this group will be fertilized with Piezo-ICSI |
Primary outcome
fertilization rate post intracytoplasmic sperm injection
Time frame: 16-18 hours post intracytoplasmic sperm injection
The primary outcome measure was the fertilization rate 16-18 hours post intracytoplasmic sperm injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Jie D Mei, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezo-ICSI in people with Infertility, Female and Intracytoplasmic Sperm Injections, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 2 inclusion and 4 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 14 Jun 2024. 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 Haixiang Sun, MD (025-83106666, haixiang_sun@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertilization rate post intracytoplasmic sperm injection (time frame: 16-18 hours post intracytoplasmic sperm injection). 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 14 Jun 2024.