Actively Recruiting

Age: 0 - 38Years
FEMALE
Healthy Volunteers
NCT06839495

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

Led by Inti Labs · Updated on 2025-02-21

200

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0 - 38Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women who have started in vitro fertilization (IVF) treatment and related examinations
  • Female participants aged 38 years or younger with an anti-Müllerian hormone (AMH) concentration greater than 1.1 ng/mL
  • Participants with a collected oocyte count of more than 10
  • Participants who consent to undergo IVF with intracytoplasmic sperm injection (ICSI) and time-lapse embryo culture
Not Eligible

You will not qualify if you...

  • 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/m²
  • Patients undergoing IVF using sperm retrieved through surgical extraction
  • Patients undergoing IVF using donated oocytes or donated sperm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lee Women's Hospital

Taichung, Taiwan

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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