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NCT Number: NCT06839495

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

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.

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Key information

Age range

Up to 38 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Usable blastocyst rates

    Time frame: 4 weeks

    Usable blastocyst rates in each oocyte quality grading group.

Secondary outcomes

  1. Pregnancy outcomes.

    Time frame: 12 months

    The correlation between oocyte quality grading groups and pregnancy outcomes.

Sponsors and collaborators

Lead sponsor

Inti Labs

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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