To Investigate the Relationship Between the Viscoelastic Properties of the Zona Pellucida of Human Oocyte and the Blastocyst Utilization Rate

NCT06839495 | Recruiting

• 1 other identifier: CS2-23192
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Oocyte; Zona Pellucida; Viscoelastic Property

Outcome Measures

Primary Outcomes (1)

• Usable blastocyst rates

  Usable blastocyst rates in each oocyte quality grading group.

  4 weeks

Secondary Outcomes (1)

• Pregnancy outcomes.

  12 months

Eligibility Criteria

• Age: Up to 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who have started the in vitro fertilization (IVF) treatment and related examinations.

You may qualify if:

• Women who have started the in vitro fertilization (IVF) treatment and related examinations.
• 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.
• Participants who consent to undergoing IVF with intracytoplasmic sperm injection (ICSI) and time-lapse embryo culture.

You may not qualify if:

• Women diagnosed with untreated uterine abnormalities as assessed by a physician.
• Participants with a body mass index (BMI) outside the range of 18.5-30 kg/m\^2.
• Patients undergoing IVF using sperm retrieved through surgical extraction.
• Patients undergoing IVF using donated oocytes or donated sperm.

Sponsors & Collaborators

• Inti Labs: lead

Study Sites (1)

Lee Women's Hospital

Taichung, Taiwan

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 21, 2025
• Study Start: July 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

TW (1)