Eggcell trial
Research type
Research Study
Full title
A trial of egg recovery rates for IVF using a collection chamber that provides environmental control: Eggcell Trial.
IRAS ID
194709
Contact name
Alison Murdoch
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
About 1 in 7 couples have difficulty conceiving and infertility is recognised to be one of the most life-changing events in healthy young adults. In most cases, IVF is the only option that will improve their chance of a family.
Routine IVF treatment involves collecting eggs by inserting a needle through the vagina into follicles in the ovary. Each follicle contains an egg. The eggs are then taken to the laboratory to be mixed with sperm to create an embryo. The embryo is transferred to the womb about 3-5 days later.
During this procedure eggs and embryos are outside the protective environment of the body and are susceptible to environmental stress. There is robust evidence to show that the stage of development of eggs at the time of aspiration is exquisitely sensitive to temperature and pH changes (Wang et al., 2001; Swain and Pool, 2009), pH needing to be optimal for good fertilisation. Furthermore there is evidence that the genetic processes that are occurring during that final maturation of the egg are highly susceptible to such changes. Therefore it is routine practice within clinical embryology to aim for stable temperature and pH conditions but we have shown that significant fluctuations occur during routine practice.
We have developed "Eggcell", a medical device that enables collection of the fluid into an enclosed, warm environment. This protects the eggs from the environmental variations that occur in the standard test tube procedures. Eggcell use may improve the chance of eggs developing normally.
The chance of recovering the egg from each follicle is ~68%. An important indicator of successful treatment is the number of eggs collected per woman. It is essential that we demonstrate Eggcell does not compromise the recovery rate. This proposal is to carry out a clinical trial to compare the recovery rate of eggs aspirated from the ovary using Eggcell with the current test tube method. Additional endpoints include fertilisation rates and embryo quality. Although the aim of this proposal is to develop this product for launch into the market, the first step is to ensure that we have robust evidence of efficacy, efficiency and benefit.
We propose a multi-centre randomised clinical trial comparing egg recovery rates using Eggcell compared to current technology.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0330
Date of REC Opinion
31 Oct 2016
REC opinion
Favourable Opinion