Improving fertilization and embryo development in older women with infertility
A Single-center Randomized Controlled Trial on Piezo-ICSI Improving Oocyte Fertilization and Embryo Development in Elderly Infertile Patients
This study is testing a new method called Piezo-ICSI to see if it can help older women with infertility have better fertilization and embryo development compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 35 Years to 42 Years |
| Sex | Female |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06459778 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Piezo-ICSI in enhancing the fertilization and embryo development of oocytes in elderly women facing infertility. Participants will undergo a randomized controlled approach where their oocytes will be split into two groups: one receiving Piezo-ICSI and the other receiving conventional ICSI. The study will assess whether the Piezo-ICSI method leads to better outcomes in terms of fertilization rates and embryo quality. All participants will be informed about the study and provide consent before participating.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged between 35 and 42 years who have undergone two or fewer IVF/ICSI cycles.
Not a fit: Patients who are egg donors, have chromosome abnormalities, or suffer from certain uterine diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the chances of successful pregnancies for older women undergoing assisted reproductive technology.
How similar studies have performed: While the specific approach of Piezo-ICSI is relatively novel, similar studies have shown promising results in improving fertilization outcomes with advanced ICSI techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Haixiang Sun, MD
- Email: haixiang_sun@nju.edu.cn
- Phone: 025-83106666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.