Title: Protecting the egg: new technology to improve the method of egg collection for IVF
Funder: Department of Health (England)

Abstract: CHUMP, currently a functional R&D prototype (Suppl. Fig 4), would progress with this funding to a CE marked device for clinical use. An application will be submitted to the NICE Medical and Technology Evaluation programme to facilitate incorporation into the NHS. Development of this CLASS IIa Medical Device is planned over 2 years/3 milestones defined by advanced prototype development, product manufacture and pilot clinical study leading to commercial progression with appropriate regulatory compliance and IP protection. CHUMP1 will be a sterile pack containing the aspiration needle, chamber and connecting tubing, all disposable at completion of the clinical procedure. CHUMP2 is a non-disposable pump and heating system. The role of the partners/suppliers are: CHUMP1: The needle and modified tubing will be supplied by Casmed, an ISO13485 certified company. The chamber design and prototype manufacture will be contracted to Nanofactory who have expertise in medical device design and is an ISO9001 registered manufacturing facility. Testing of CHUMP1 will be performed to GLP at Newcastle University. CHUMP2: Will be developed by Labman. Work Package 1: Advanced prototype Design, Manufacture & Test: Design of CHUMP1 focuses on: Composition : Materials for manufacture will already be used in standard IVF practice. Sterilisation : The prototype will be manufactured at laboratory scale and the feasibility of sterilisation (steam and gamma sterilisation) will be tested by spike/recovery. Following sterilisation the product will be tested for toxicology. Manufacture : To ensure the practicality of attachment ports, the compatibility with current practice and the security of the oocytes. CHUMP2 development will define the pump and heating mechanism. The functionality e.g. temperature control and flow rates will be tested using a mock procedure to ensure compatibility with CHUMP1. CHUMP1/CHUMP2 combined will be tested in a mock procedure and compared with the existing procedure for temperature, pH profiling, air tightness of the system, clinical utility and oocyte recovery. The results will be encompassed in a design review, completing Milestone ( MS)1. UK priority filing will be made based on this specification and a marketing partner secured. Work Package 2: Manufacture of CHUMP1 and CHUMP2 and CE mark: Three batches of CHUMP1 will be manufactured to ISO13485 (Medical Devices). These will be assembled with needle and tubing into CHUMP1 by Labman and sterilisation validation conducted. Toxicity testing will be completed including human sperm toxicity tests and the mouse embryo assay used routinely by providers of products to the IVF industry. Three prototypes of CHUMP2 will be manufactured to ISO13485 and ISO60601 (Medical Electrical Equipment) and tested. A regulatory file will be compiled for the CHUMP1 and CHUMP2 and an application for CE marking to a notifiable body will define MS2 . Work Package 3: Pilot study for device validation: Comparative tests will be performed on women donating oocytes for other research. After amendment of ethical approval, CHUMP will be used to collect oocytes from one ovary and the conventional system to collect from the contralateral ovary. The proportion of oocytes that have normal spindles and fertilise following IVF/ICSI will be compared between systems Embryo development and grading will be performed at regular intervals from the time of fertilisation to blastocyst development. We will perform comparative immunohistochemistry and fluorescent based experiments on these blastocysts to ensure expression of key developmental proteins as well as to compare the proportion of apoptotic cells. We currently have a database of >60 blastocysts using the conventional system (Suppl. Fig 5-7). A patent application will be filed via the Patent Cooperation Treaty and a paper will be submitted for peer reviewed publication. Submission to the NICE Medical Technology Evaluation Programme will be filed. This completes MS3 .


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH