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Physiological intracytoplasmic sperm injection (PICSI)

Treatment add-on with limited evidence

For most patients, having a routine cycle of proven fertility treatment is effective without using any treatment add-ons.

Red traffic light

Red

PICSI is rated red because there is no evidence from randomised controlled trials (RCTs) to show that it is effective at improving the chances of having a baby for most fertility patients.

What does this traffic light rating mean?

Our traffic-light rated list of add-ons consists of three colours that indicate whether the evidence, in the form of high-quality RCTs, shows that a treatment add-on is effective at improving the chances of having a baby for most fertility patients.  

We give a red symbol for an add-on where there is no evidence from RCTs to show that it is effective at improving your chances of having a baby for most fertility patients.

The January 2019 consensus statement (PDF) between the HFEA and ten other professional and patient bodies agreed that treatments that have no strong 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.

For specific patient groups there may be reasons for the use of a treatment add-on other than improving your chances of having a baby. 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.

Our traffic light ratings only indicate the effectiveness of a treatment add-on, at improving your chances of having a baby. Specific safety concerns about a treatment add-on are included under the dedicated section ‘Is this treatment add-on safe?’.

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.

What’s the evidence for PICSI?

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.

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 are available on the SCAAC webpage.

This Cochrane review has further information on the evidence for PICSI.

Is this treatment add-on safe?

PICSI is a non-invasive test performed on a semen sample as an additional step in the ICSI process. The risks associated with the use of ICSI also apply to PICSI. However, PICSI does not carry any additional known risks for the person undergoing fertility treatment or the child born as a result of fertility treatment.

If you have any questions about the safety and risks, your clinic will be able to discuss whether a treatment add-on would be safe for you to use considering your specific medical history and circumstances.

Find out more about ICSI

What are treatment add-ons?

  • optional additional treatments, also referred to as ‘supplementary’, ‘adjuvants’ or ‘embryology treatments’.
  • often claim to be effective at improving the chances of having a baby (live birth rate) but the evidence to support this for most fertility patients is usually missing or not very reliable.
  • likely to involve an additional cost on top of the cost of a routine cycle of proven fertility treatment. Some treatment add-ons can cost hundreds or thousands of pounds each.

It is important to keep in mind that for most patients, having a routine cycle of proven fertility treatment is effective without using any treatment add-ons. If you are paying directly for your own treatment, you may want to think about whether it might be more effective and/or affordable to pay for multiple routine proven treatment cycles, rather than spending large sums of money on a single treatment cycle with treatment add-ons that haven’t been proven to be effective at increasing the likelihood of you having a baby.

We aim to publish clear and reliable information about some of the treatment add-ons that don’t have enough evidence, from high-quality randomised control trials (RCTs), to show that they are effective at improving your chances of having a baby.

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

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Review date: 19 April 2023

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