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

Infertility, Female Clinical Trial

Official title:

A Single-center Randomized Controlled Trial on Piezo-ICSI Improving Oocyte Fertilization and Embryo Development in Elderly Infertile Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459778
• Other study ID #: SZ-Piezo-1
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Haixiang Sun, MD
• Phone: 025-83106666
• Email: haixiang_sun[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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