Piezo-ICSI to Improve the Developmental Potential of Fertilized Oocytes in Aged Infertility Women With Assisted Reproductive Technology
NCT ID: NCT06459778
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
147 participants
INTERVENTIONAL
2023-11-20
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Piezo-ICSI group, Oocytes in this group will be fertilized with Piezo-ICSI
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.
Piezo-ICSI
Participants had their oocytes cohort divided, where half were injected using conventional ICSI and the other half were injected using Piezo-ICSI.
Control group, Oocytes in this group will be fertilized with conventional ICSI
No interventions assigned to this group
Interventions
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Piezo-ICSI
Participants had their oocytes cohort divided, where half were injected using conventional ICSI and the other half were injected using Piezo-ICSI.
Eligibility Criteria
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Inclusion Criteria
2. Number of IVF/ICSI cycles ≤ 2
Exclusion Criteria
2. Chromosome abnormality;
3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
4. Patients with repeated implantation failure
35 Years
42 Years
FEMALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Wang Shanshan
Reseaerch fellow
Locations
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Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SZ-Piezo-1
Identifier Type: -
Identifier Source: org_study_id
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