RecruitingNot ApplicableNCT06459778

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

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


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

147 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 35 YearsMax Age: 42 Years

Inclusion Criteria2

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

Exclusion Criteria4

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

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Interventions

DEVICEPiezo-ICSI

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


Locations(1)

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

Nanjing, Jiangsu, China

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NCT06459778


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