Not yet recruitingNAINTERVENTIONAL

Direct Warming Frozen Embryo Transfer Outcomes in Assisted Reproductive Technology

This research is looking into a new, faster way to thaw frozen embryos used in IVF treatment. It's called the 'direct warming' method, and it dramatically shortens the thawing time compared to the traditional approach. The main goal is to see if this new method can lead to more successful pregnancies and live births for women aged 18 to 45 who are having IVF. Researchers also want to find out if it's more affordable. Participants will have either the new quick thaw or the standard thaw, and then their pregnancy outcomes will be carefully checked. The aim is to make IVF embryo transfers simpler, quicker, and potentially more successful.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Chinese University of Hong Kong

Enrolment target

578

Start

01 Sep 2025

Estimated completion

31 Oct 2027

Frozen Embryo Transfer (FET)Assisted Reproductive Techniques In Vitro Fertilization (IVF)Cryopreservation of Embryos Pregnancy Outcome After in Vitro Fertilization (IVF)

What is this study about?

When you have IVF, sometimes embryos are frozen for later use. This study is all about improving how these frozen embryos are thawed before being put back into the womb. Usually, it's a multi-step process, but researchers have developed a new, much quicker way called the 'direct warming' method. They want to see if this new method works just as well, or even better, than the traditional one when it comes to helping women get pregnant and have healthy babies.

The main idea behind this new 'direct warming' method is to make the thawing process simpler and faster. The standard way can take about 20 minutes and involves several steps, sometimes using special liquids that protect the embryo but also need careful handling. The new method aims to thaw the embryo in just 3 minutes, using less complex steps and potentially fewer of these special liquids. The study will carefully compare both methods to see which one results in more successful pregnancies, pregnancies that continue, and ultimately, more babies being born.

Beyond just looking at pregnancy rates, the researchers are also interested in whether this new direct warming method could be more cost-effective. They'll be comparing the costs of materials and the time involved for both methods. By doing this, they hope to find a way to improve IVF treatment that is not only effective but also potentially more efficient and accessible for couples undergoing fertility treatment in the future.

Key takeaways

This study compares two ways to thaw frozen embryos for IVF.
It aims to see if a new 'direct warming' method is faster and just as good, or better, than the usual method.
The goal is improved pregnancy rates and live births for women using IVF.
It also looks at whether the new method is more cost-effective.
Participants will have routine pregnancy follow-ups.

Who may be eligible?

To be able to take part in this study, you need to be a woman between 18 and 45 years old. You must be planning to have a single embryo transferred to your womb during your frozen embryo transfer (FET) cycle, and there needs to be at least one good quality embryo available for this. It's also really important that you understand what the study involves and are happy to give your informed consent to participate.

You would not be able to join this study if you have had repeated failed IVF cycles or multiple miscarriages before. Also, if you have certain womb problems, like large fibroids or polyps, you wouldn't be eligible. Finally, if you're not able or willing to give your full consent to join, then this study wouldn't be right for you.

Quick self-check

Are you a woman aged between 18 and 45 years?
Are you planning to have just one embryo transferred for your frozen embryo cycle?
Do you have at least one good quality frozen embryo ready for transfer?
Are you willing and able to understand and agree to participate in the study?
Have you *not* had many failed IVF cycles or miscarriages before?
Do you *not* have certain womb problems, such as big fibroids or polyps?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly chosen to have your frozen embryo thawed using either the new 'direct warming' method or the standard multi-step method. This thawing procedure happens right before your embryo transfer. After the transfer, you would follow the usual care for pregnancy checks, which includes blood tests to confirm pregnancy and ultrasound scans to check on the baby's development. The study will follow your pregnancy outcomes until birth. The overall duration involves the lead-up to your embryo transfer, the transfer itself, and then routine follow-ups for your pregnancy, which typically run for about nine months.

Potential risks and benefits

Participating in this study might offer the benefit of receiving an embryo thaw method that could potentially improve your pregnancy success, though this is what the study aims to find out. There are no known additional risks beyond those usually associated with frozen embryo transfers, and both methods use established clinical practices for thawing. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
The CUHK Medical centre
Shatin,NT, Hong Kong
The Homerton Hospital
London, United Kingdom

Common questions

What is an 'embryo transfer'?

It's when an embryo (a fertilised egg) that has been grown in the lab is placed into a woman's womb, hoping it will lead to a pregnancy.

What's the difference between the two thawing methods?

One method is the standard, multi-step process that takes around 20 minutes. The new 'direct warming' method is much quicker, taking only 3 minutes, and aims to be simpler.

Will I know which method my embryo gets?

No, you will be randomly assigned to one method or the other, so neither you nor the doctors will choose which one you receive. This helps ensure fair results for the study.

What are 'live birth outcomes'?

This refers to whether the pregnancy results in a live baby being born, which is the ultimate goal of fertility treatment.

Does this study involve new medicines?

No, this study is comparing two ways of thawing embryos, not testing new medications. It uses methods already in clinical practice, just in a new comparison.

How to find out more

Yiu Leung D Chan, DPhil

drdcyl16@cuhk.edu.hk (852) 3505 3199 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.