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Higher pregnancy success with device that mimics natural sperm migration

Artificial insemination treatment for couples unable to conceive has a high failure rate. But an EU-funded project has shown that a device that more closely mimics the natural time frame of conception results in more pregnancies.

Health

Infertility affects around one in six couples globally. Currently, the most common but expensive and invasive treatment for assisting reproduction technology is in vitro fertilisation (IVF). But before going through this risky procedure of removing eggs from the ovaries, mixing them with sperm to create a pre-embryo which is put back into the uterus, some three to six attempts of simpler intrauterine insemination (IUI) are carried out injecting sperm directly into the uterus via a designated balloon catheter using a syringe. “Unfortunately the success rate of IUI is not very high, ranging between 6 % and 12 %, depending on the age of the patient,” says project coordinator Amnon Weichselbaum, co-founder and scientific director of Fertiligent, a company in Israel that developed a new insemination device with the help of EU funding for the project EVIE 2.0. Previous research found that it normally takes about 4 hours for sperm to travel up the uterine cavity via the fallopian tubes to the waiting ovum. “Instead of bombarding the uterus with sperm, we thought we could increase the success rate with a simple treatment of IUI with our slow release concept,” Weichselbaum adds. “Our concept was to put the sperm as close as possible to the waiting ovum and emulate the natural 4-hour time frame it takes for sperm to migrate through the cervix and enter the uterine cavity by releasing the sperm gradually over that period,” he explains. Pregnancy rates using the simple first-generation device developed by the team are 2.5 times higher compared to regular IUI, saving on expensive repeated cycles of IVF. “Crucially that success is attributed in large part to increasing the number of sperm reaching the fallopian tubes,” says Weichselbaum. Clinical trials showed slow-release insemination is superior to the so-called bolus technique of injecting the sperm in one shot.

More streamlined device

The first-generation device known as EVIE 1.0 uses a syringe inside a smart pump that slowly releases the sperm in a linear mode directly through a designated catheter to the uterus, Weichselbaum explains. The second-generation EVIE 2.0 device developed with EU funding is smaller and easier to use, as well as being more streamlined and robust compared to the earlier version. It uses a more advanced balloon catheter that can direct the sperm into the openings of the fallopian tubes, shortening the distance between the sperm and the waiting ovum. “The new catheter will be able to improve the success rate,” Weichselbaum explains. It also bypasses the cervix where sperm can get stuck in cervical mucus unable to complete their migration. This increases the chance of egg fertilisation.

Simple kit

“It’s a single-use kit – the pump itself with a sterile syringe that is used for regular IUI, and our designated balloon catheter,” Weichselbaum adds. “The beauty is in its simplicity. All the gynaecologist has to do is insert the catheter into the uterus, inflate the balloon, attach the device by strap to the patient’s leg and press the button, then everything is done automatically.” The single slow-release EVIE 2.0 device performed well in laboratory tests. “We found that the linear mode of sperm release in exactly 4 hours is much more exact and reliable than with EVIE 1.0” Weichselbaum notes. While the earlier mechanical device comprised 20 different parts and components, the new version has only four components making it simpler and cheaper to produce. The advanced prototype will be used for clinical studies to fine-tune it before bringing it to the market.

Keywords

EVIE 2.0, EVIE 1.0, fertility, insemination, IUI, conception, IVF, uterus, ovary, fallopian tubes, sperm, catheter

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9 October 2020