NCT06839495 To Investigate the Relationship Between the Viscoelastic Properties of the Zona Pellucida of Human Oocyte and the Blastocyst Utilization Rate
| NCT ID | NCT06839495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inti Labs |
| Condition | Oocyte |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-07-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In in vitro fertilization (IVF) treatment, oocyte quality is one of the key factors influencing the success rate of fertilization. The zona pellucida (ZP) is a spherical structure that surrounds the human oocyte and, together with cumulus cells, forms the cumulus-oocyte complex (COC). These two components engage in bidirectional communication and metabolic regulation to support oocyte growth and maturation. Additionally, the physical rigidity of the zona pellucida plays an important role in the fertilization process. OPAL X1 is a non-invasive and highly safe device specifically designed to measure the viscoelastic properties of the zona pellucida. This system consists of an ultra-precise pressure control mechanism and analytical software to assess oocyte quality before fertilization. OPAL X1 applies pressure through a micropipette while simultaneously recording the movement of the zona pellucida within the micropipette. An algorithm then analyzes the recorded motion images and classifies the oocytes into different quality grades (Grade A, B, C). This study aims to investigate the correlation between oocyte classification results obtained from the OPAL X1 grading system and oocyte quality. By integrating spindle-view and time-lapse technology, the study seeks to identify the optimal parameters for oocyte quality assessment. Furthermore, these findings will be applied to predict the success rate of intracytoplasmic sperm injection (ICSI), the likelihood of blastocyst formation, and pregnancy outcomes after embryo transfer. Ultimately, this study aims to provide more efficient and timely embryo development information before IVF, assisting clinicians in formulating and optimizing IVF treatment strategies.
Eligibility Criteria
Inclusion Criteria: 1. Women who have started the in vitro fertilization (IVF) treatment and related examinations. 2. Female participants aged ≤38 years with an anti-Müllerian hormone (AMH) concentration greater than 1.1 ng/mL and a collected oocyte count of more than 10. 3. Participants who consent to undergoing IVF with intracytoplasmic sperm injection (ICSI) and time-lapse embryo culture. Exclusion Criteria: 1. Women diagnosed with untreated uterine abnormalities as assessed by a physician. 2. Participants with a body mass index (BMI) outside the range of 18.5-30 kg/m\^2. 3. Patients undergoing IVF using sperm retrieved through surgical extraction. 4. Patients undergoing IVF using donated oocytes or donated sperm.
Frequently Asked Questions
Who can join the NCT06839495 clinical trial?
This trial is open to female participants only, up to 38 Years, studying Oocyte. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839495 currently recruiting?
Yes, NCT06839495 is actively recruiting participants. Visit ClinicalTrials.gov or contact Inti Labs to inquire about joining.
Where is the NCT06839495 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06839495 clinical trial?
NCT06839495 is sponsored by Inti Labs. The trial plans to enroll 200 participants.