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

Last updated: February 19, 2025
Sponsor: Inti Labs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Shingles

Herpes Simplex Infections

Chickenpox (Varicella Zoster Infection)

Treatment

N/A

Clinical Study ID

NCT06839495
CS2-23192
  • Ages < 38
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Women who have started the in vitro fertilization (IVF) treatment and relatedexaminations.

  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

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.

Study Design

Total Participants: 200
Study Start date:
July 31, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Lee Women's Hospital

    Taichung,
    Taiwan

    Active - Recruiting

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