Piezo-ICSI to Improve the Developmental Potential of Fertilized Oocytes in Aged Infertility Women With Assisted Reproductive Technology

NCT06459778 | Recruiting

• 1 other identifier: SZ-Piezo-1
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Infertility, Female; Intracytoplasmic Sperm Injections

Outcome Measures

Primary Outcomes (1)

• fertilization rate post intracytoplasmic sperm injection

  The primary outcome measure was the fertilization rate 16-18 hours post intracytoplasmic sperm injection

  16-18 hours post intracytoplasmic sperm injection

Study Arms (2)

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.

Device: Piezo-ICSI

Control group, Oocytes in this group will be fertilized with conventional ICSI

NO INTERVENTION

Interventions

Piezo-ICSI DEVICE

Participants had their oocytes cohort divided, where half were injected using conventional ICSI and the other half were injected using Piezo-ICSI.

Piezo-ICSI group, Oocytes in this group will be fertilized with Piezo-ICSI

Eligibility Criteria

• Age: 35 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years ≤ age ≤ 42 years;
• Number of IVF/ICSI cycles ≤ 2

You may not qualify if:

• Egg donor cycle
• Chromosome abnormality;
• Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
• Patients with repeated implantation failure

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Haixiang Sun, MD

CONTACT

025-83106666; haixiang_sun@nju.edu.cn

Jie D Mei, MD

CONTACT

meijie560@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseaerch fellow

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 14, 2024
• Study Start: November 20, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)