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CRO Service for NICS to Assist IVF Technology Development

2023-07-18

Recently, the clinical trial of Non-invasive Capacity Screening (NICS) developed by Yikon Genomics, an enterprise dedicated to the development and application of single-cell whole-genome amplification and sequencing technologies and provides precision medical detection technology, is conducted orderly and Quarkmed is to provide CRO service of the whole process for that.

 

Figures from National Health Commission show that the infertility rate of childbearing couples in China rises from 2.5%-3% 20 years ago to 12%-15% nowadays and more than 50 million people are of infertility. Some further studies show that the infertility rate in China could rise to 18.2% in 2023 due to the increased average age of first childbearing, unhealthy life style and environmental factors. Therefore, more and more families may choose to use assisted reproductive technology (ART).

 

The families entering into ART procedure is increasing progressively year by year, however, the number of pregnancy and live birth via ART are still low. At present, preimplantation genetic testing (PGT), widely used worldwide is an invasive technology with many potential risks. Under such circumstances, studies on NICS is imperative.

 

As is known to all, Quarkmed is to provide CRO service for this NICS clinical trial, including initial meeting, subject selection, EDC input/inspection/modification, data statistics and summary and others. In the process of subject selection, our CRC team members made communication with subject actively and patiently, specific to their instable emotion, to ensure dropout rate. This project is of long follow-up duration and large time span, CRC is required to notice the follow-up points and CRA to timely determine the follow-up points are within the time window specified or not, which needs a tacit cooperation and teamwork. For this time, the number of subjects of 3 centers under Quarkmed, Peking University Third Hospital, Hebei Maternity Hospital and 301 Hospital, is nearly 50% of the total subjects for the trial, with a quick enrollment and smooth promotion.

 

The joint collaboration of Yikon Genomics and Quarkmed will further prove the advantages of NICS technology in clinical application and assist IVF technology reaching a new level.

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