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

Last updated: June 13, 2024
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Piezo-ICSI

Clinical Study ID

NCT06459778
SZ-Piezo-1
  • Ages 35-42
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. 35 years ≤ age ≤ 42 years;

  2. Number of IVF/ICSI cycles ≤ 2

Exclusion

Exclusion Criteria:

  1. Egg donor cycle

  2. Chromosome abnormality;

  3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterinediseases;

  4. Patients with repeated implantation failure

Study Design

Total Participants: 147
Treatment Group(s): 1
Primary Treatment: Piezo-ICSI
Phase:
Study Start date:
November 20, 2023
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

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

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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