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Physiological intracytoplasmic sperm injection (PICSI)

Treatment add-on

PICSI is rated red

PICSI is rated red

Red

What does this traffic light rating mean?

The traffic light rating system consists of three colours that indicate whether the evidence, in the form of high-quality randomised control trials (RCTs), shows that a treatment add-on can safely improve the live birth rate for someone undergoing fertility treatment.

We give a red symbol for an add-on where there is no evidence to show that it can improve live birth rates. We also give a red symbol for an add-on where there is evidence to show that the add-on is unsafe.

The January 2019 consensus statement between the HFEA and 10 other professional and patient bodies agreed that treatments that have no robust evidence of their safety and/or effectiveness should only be offered in a research setting. Patients should not be charged extra to take part in research, including clinical trials, and should not be charged to use red-rated treatment add-ons if the reason for its use is to improve live birth rates.

For specific patient groups there may be reasons for the use of a treatment add-on other than to increase live birth rate, for example to reduce your chances of having a miscarriage. In these situations it may be appropriate for you to be offered a treatment add-on as part of your treatment and not in a research setting.

What is PICSI?

Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select sperm to use in Intracytoplasmic sperm injection (ICSI) treatment. It involves placing sperm with hyaluronic acid (HA), a natural compound found in the body. PICSI identifies sperm that can bind to HA and these sperm are selected for use in treatment.

Are there any risks?

PICSI is a non-invasive procedure performed on a semen sample as an additional step in the ICSI process. Risks associated with the use of ICSI also apply to PICSI; there are no significant additional risks to the patient or embryo.

Find out more about ICSI

What’s the evidence for PICSI?

At the October 2019 Scientific and Clinical Advances Advisory Committee (SCAAC) meeting the Committee evaluated the evidence base for PICSI. Minutes of this discussion and the evidence used to inform this discussion is available here.

There have been several studies comparing PICSI with standard ICSI, but there is very little evidence to suggest any benefit of using it. A large RCT was recently carried out which showed that using PICSI did not increase the chances of having a baby.

The results of this large RCT did suggest that PICSI may be beneficial in relation to a potential reduction in miscarriage. It is important to keep in mind that this evidence was the secondary outcome, that is, it was not the aim of this research. This means that the study was not designed to investigate the effect of PICSI on miscarriage rate, making these secondary results less reliable. For this reason it is important to discuss your individual circumstances with your doctor.

What are treatment add-ons?

Treatment add-ons are optional additional treatments that you may be offered on top of your routine fertility treatment, often at an additional cost. Some clinics may refer to treatments add-ons as ‘supplementary’ or ‘embryology treatments’. There are a wide range of treatment add-ons on offer including tests, drugs, equipment, holistic or alternative therapies, and surgical interventions.

However, all treatment add-ons share one common characteristic: they claim to improve the chances of having a baby (live birth rate). Evidence on whether some treatment add-ons are safe or effective is often missing or absent. These claims can attract a lot of attention with many patients opting for a treatment add-on thinking that it may be the best option for them despite there being little or no evidence to prove it is.

Treatment add-ons have varying levels of scientific evidence to support their effectiveness and safety and, at times, this evidence can be contradictory. It is important to keep in mind that for most patients, routine fertility treatment is an effective option on its own.

We aim to publish clear and reliable information about some of the treatment add-ons that lack sufficient evidence to show that they are effective and/or safe. This allows patients to make an informed decision about whether using a treatment add-on as part of their treatment is the best option for them.

To make it easier to understand the scientific evidence for each treatment add-on we have developed the HFEA’s traffic-light rated list of add-ons.

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Review date: 25 August 2022

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