A Single-center Randomized Controlled Trial on Piezo-ICSI Improving Oocyte Fertilization and Embryo Development in Elderly Infertile Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 42
Healthy Volunteers: f
View:
• 35 years ≤ age ≤ 42 years;
• Number of IVF/ICSI cycles ≤ 2
Locations
Other Locations
China
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Contact Information
Primary
Haixiang Sun, MD
haixiang_sun@nju.edu.cn
025-83106666
Backup
Jie D Mei, MD
meijie560@163.com
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2026-05
Participants
Target number of participants: 147
Treatments
Experimental: 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.
No_intervention: Control group, Oocytes in this group will be fertilized with conventional ICSI
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School