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

Not Applicable

Recruiting

• Conditions: Infertility, Female; Intracytoplasmic Sperm Injections
• Interventions: Device: Piezo-ICSI

• Registration Number: NCT06459778
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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).

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 Timeline

• Study Start: 2023-11-20
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 147

Inclusion Criteria

1. 35 years ≤ age ≤ 42 years;
2. Number of IVF/ICSI cycles ≤ 2

Exclusion Criteria

1. Egg donor cycle
2. Chromosome abnormality;
3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
4. Patients with repeated implantation failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piezo-ICSI group, Oocytes in this group will be fertilized with Piezo-ICSI	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China