CLINICAL STUDIES
Our clinical studies are conducted with a stringent set of protocols and ethical standards to ensure insightful and unbiased results. Here are our ongoing clinical studies
GLOBAL RANDOMIZED CONTROLLED TRIAL (RCT) FOR VALIDATION OF ORA
Description: This study aims to validate ORA, a non-invasive endometrial receptivity test utilizing microRNA biomarkers in the blood. ORA accurately identifies a patient’s window of implantation, informing the timing of personalized embryo transfer.
Status: Ongoing
Study Objective
Our primary objective is to demonstrate the clinical benefit of ORA™ in enhancing implantation success rates in eligible patients with a history of failed implantation.
Patient Criteria
- History of at least one implantation failure with a low mosaic/euploid embryo
- Patients aged between 28-45 years
- At least one euploid embryo available for transfer
- BMI less than 30
Trial Design
- Patient Recruitment and Enrollment: We recruit and enroll patients based on the above criteria.
- Randomization: All subjects are randomized into two sub-groups:
- Receptivity-Timed Group: Frozen embryo transfer is performed based on receptivity timing results of ORA™.
- Standard Group: Frozen embryo transfer is performed based on the standard cycle. A blood draw taken on the same day as the embryo transfer is later analyzed by ORA™ to validate receptivity window.
Clinical Impact
By leveraging ORA™’s advanced technology, we strive to enhance ART success rates and improve patient outcomes. The results of the trial will be published, with authorship order based on the contribution of individual sites. In addition to sponsoring the ORA™ tests, we are providing additional incentives to patients, principal investigators, and sites to support the trial.
CLINICAL STUDY TO VALIDATE PERFORMANCE OF OPAL
This clinical study evaluates OPAL, a device specifically designed to assess the quality of human oocytes and how they impact the fertilization rate, blastocyst formation rate, implantation rate, clinical pregnancy rate and live birth rate.
Inti Labs has partnered with Lee Women’s Hospital to conduct this study.
Study Objectives
- Enhancing Fertilization Rates: We are investigating whether higher-graded eggs evaluated by OPAL correlate with improved fertilization rates.
- Embryo Grading and Quality: By analyzing embryo development, we are investigating whether higher-grade eggs evaluated by OPAL lead to higher-quality embryos. This part of the study will also compare OPAL’s grading against Gardner’s grading system and time-lapse AI scores.
- Euploidy and Implantation Potential: We are examining whether higher-graded eggs evaluated by OPAL result in more euploid embryos, which play a crucial role in successful implantation.
Methodology
- Patient Recruitment: We recruit patients and select mature oocytes (MII) for evaluation.
- OPAL Grading: Selected MII oocytes undergo precise grading using OPAL device.
- Evaluation: We assess fertilization rates, Day 3 embryo development, and Day 5 blastocyst formation.
- Correlations: We correlate OPAL’s grading with various parameters, including implantation rates and clinical pregnancy outcomes.
Clinical Impact
Our study contributes to evidence-based fertility treatments, empowering clinicians and patients with data-driven decisions. By leveraging OPAL’s advanced technology, we aim to enhance ART success rates and improve patient outcomes.
PUBLICATIONS
Our research findings are disseminated through peer-reviewed publications, contributing to the scientific understanding of IVF. Here are some of our notable publications:
A novel platform for discovery of differentially expressed microRNAs in patients with repeated implantation failure
Description: Our results demonstrate the potential of utilizing specific endometrial miRNAs as diagnostic biomarkers for predicting repeated implantation failure due to displaced window of implantation. The reproductive disease-related PanelChip we developed exhibited an accuracy exceeding 90% in predicting patients’ displaced window of implantation.
Published: April, 2021
A novel platform for discovery of differentially expressed microRNAs in patients with repeated implantation failure
Description: Our results demonstrate the potential of utilizing specific endometrial miRNAs as diagnostic biomarkers for predicting repeated implantation failure due to displaced window of implantation. The reproductive disease-related PanelChip we developed exhibited an accuracy exceeding 90% in predicting patients’ displaced window of implantation.
Published: April, 2021
Development of a Predictive Model for Optimization of Embryo Transfer Timing Using Blood-Based microRNA Expression Profile
Description: MicroRNA expression profiles from blood samples offer a non-invasive means to distinguish the three endometrial receptivity statuses. Our model from this study achieved an overall prediction accuracy of 95.9% in this regard.
Published: December, 2023
Development of a Predictive Model for Optimization of Embryo Transfer Timing Using Blood-Based microRNA Expression Profile
Description: MicroRNA expression profiles from blood samples offer a non-invasive means to distinguish the three endometrial receptivity statuses. Our model from this study achieved an overall prediction accuracy of 95.9% in this regard.
Published: December, 2023
Development of a Novel Endometrial Signature Based on Endometrial microRNA for Determining the Optimal Timing for Embryo Transfer
Description: The reproductive-related PanelChip® that analyses microRNA expression profiles could identify the optimal timing for embryo transfer with an accuracy of 93.9%, a sensitivity of 85.3%, and a specificity of 92.4%, showing a high promise of utilizing miRNA-based platform in precisely identifying the optimal timing for embryo transfer in endometrial tissue samples.
Published: March, 2024
Development of a Novel Endometrial Signature Based on Endometrial microRNA for Determining the Optimal Timing for Embryo Transfer
Description: The reproductive-related PanelChip® that analyses microRNA expression profiles could identify the optimal timing for embryo transfer with an accuracy of 93.9%, a sensitivity of 85.3%, and a specificity of 92.4%, showing a high promise of utilizing miRNA-based platform in precisely identifying the optimal timing for embryo transfer in endometrial tissue samples.
Published: March, 2024
Development and evaluation of a usable blastocyst predictive model using the biomechanical properties of human oocytes
Description: This study proposes a method to predict viable blastocysts from oocytes using biomechanical properties, surpassing traditional morphological and maternal factors. Results suggest potential for improving embryo selection with minimal impact on culture outcomes.
Accepted: March, 2024
Development and evaluation of a usable blastocyst predictive model using the biomechanical properties of human oocytes
Description: This study proposes a method to predict viable blastocysts from oocytes using biomechanical properties, surpassing traditional morphological and maternal factors. Results suggest potential for improving embryo selection with minimal impact on culture outcomes.
Accepted: March, 2024
CONTACT US
Our commitment to clinical evidence underscores our dedication to providing innovative solutions that improve outcomes in IVF treatment. For inquiries about our research or collaborations