Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial (CERTIFY)
This research, called the CERTIFY study, is for women who have had trouble getting pregnant because their embryos haven't settled properly in the womb after fertility treatment, a problem known as recurrent implantation failure. The study is testing a drug called Cimzia (certolizumab) to see if it can improve the chances of a successful pregnancy compared to a dummy treatment (sodium chloride). Doctors will be looking at whether women get pregnant and if the baby's heart is beating on a scan. They will also track if babies are born successfully, if miscarriages happen, and any side effects. This is a Phase III study, meaning it's a key step to see if the medicine works and is safe for wider use.
At a glance
What is this study about?
This study is called CERTIFY, and it's looking for adult women who have experienced something called recurrent implantation failure. This simply means that despite having fertility treatments like IVF, embryos haven't successfully settled and grown in the womb on multiple occasions. It can be a very frustrating and difficult experience for couples trying to have a baby.
The main aim of this study is to see if a medication named Cimzia helps to improve the chances of a successful pregnancy for these women. Half of the women in the study will receive Cimzia, and the other half will receive a 'dummy' treatment, which looks the same but contains only salt water (sodium chloride). This is called a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are getting. This helps us ensure the results are as fair and accurate as possible.
Researchers will closely follow the women in the study to see if they become pregnant and if the baby's heart can be seen beating on an ultrasound scan — this is considered a 'clinical pregnancy'. They will also be tracking other important things, like whether a baby is born successfully, if there are any miscarriages, and any side effects or problems that might occur during the pregnancy, such as multiple pregnancies, early births, or any health concerns for the baby. By comparing the results between the two groups, doctors hope to understand if Cimzia truly makes a difference.
Key takeaways
- This study is for women who have had trouble getting pregnant after fertility treatments.
- It tests if a medicine called Cimzia can help embryos successfully implant and grow.
- Half of participants will get Cimzia, and half will get a dummy treatment.
- Researchers will track pregnancies, live births, and any health concerns.
- You will receive injections and have regular check-ups.
- You can stop participating at any time.
Who may be eligible?
This study is specifically designed for women aged 18 or older. You must be female to take part.
The key requirement is that you have a history of recurrent implantation failure. This means you’ve had several attempts at getting pregnant through fertility treatments where embryos were transferred into your womb, but they didn't successfully implant and grow.
While the exact number of failed attempts or the type of fertility treatment isn't fully detailed here, your doctor will be able to tell you if your individual medical history matches the study's specific criteria.
- Are you female?
- Are you 18 years old or older?
- Have you experienced several failed attempts at getting pregnant after fertility treatments?
- Are you currently trying to get pregnant with fertility treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will receive either Cimzia or a dummy treatment given as an injection. These injections come in pre-filled syringes. You will have regular visits to the clinic for medical check-ups, blood tests, and ultrasound scans to monitor your health and any pregnancy development.
The main thing doctors will be looking for is if you become pregnant and if a heartbeat can be seen on an ultrasound scan around 5 weeks after the embryo would have implanted. They will continue to follow your pregnancy until delivery, tracking the baby's health at birth. They will also monitor for any miscarriages or other health events throughout the study.
The total duration of your participation would involve the treatment period, monitoring for pregnancy, and follow-up until delivery and potentially for a short period after. The exact number of visits and tests will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is 'recurrent implantation failure'?
It means that after several attempts at fertility treatments like IVF, the embryos haven't successfully settled and grown in the womb.
What is Cimzia?
Cimzia is a medicine that will be given as an injection, and the study is seeing if it helps women with recurrent implantation failure get pregnant.
What is a 'double-blind' study?
It means neither you nor your doctors will know if you're getting the actual medicine or a dummy treatment, which helps make the results fair.
Will I get pregnant if I join this study?
The study aims to see if the medicine *increases* the chance of pregnancy, but it cannot guarantee you will get pregnant.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.