RecruitingOBSERVATIONAL

Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment

This research is investigating if there's any difference in pregnancy success when an embryo is transferred into the womb on day 6 after IVF, compared to the usual day 5. Many IVF centres prefer day 5 transfers, but sometimes it's not possible to do them every day, for example, on a Sunday. Transferring on day 6 might offer more flexibility and could also help doctors pick the best embryo. The study wants to find out if moving the embryo on day 6 leads to the same number of pregnancies and miscarriages as moving it on day 5. Three fertility centres in Germany are taking part in this important study.

At a glance

Status

Recruiting

Sponsor

Infertility Treatment Center Dortmund

Enrolment target

2,400

Start

26 Jun 2024

Estimated completion

01 Mar 2028

Infertility Reproductive Issues

What is this study about?

This study is about a small but important part of IVF (In Vitro Fertilisation) treatment, specifically when the embryo is placed into the woman's womb. Usually, this happens on Day 5 after egg collection and fertilisation. However, some fertility clinics can't perform transfers every single day of the week, for example, on a Sunday, which can make a Day 5 transfer difficult to arrange for everyone.

Because of these scheduling challenges, some clinics might transfer the embryo on Day 4 or Day 6 instead. Previous research has already suggested that transferring on Day 4 is just as good as Day 5. Now, this new study aims to see if transferring the embryo on Day 6 is also just as effective. Day 6 transfers might offer some advantages, such as giving doctors more time to observe the embryo's development and pick the healthiest one, or simply providing more flexible timing for patients.

The main goal of the study is to compare the number of successful pregnancies (where a baby's sac is seen on a scan) between women who have a Day 5 transfer and those who have a Day 6 transfer. They will also look at how many pregnancies result in a miscarriage. The study is taking place in three fertility clinics in Germany and will help doctors understand the best time to transfer embryos for successful IVF treatment.

Key takeaways

Compares Day 5 vs. Day 6 embryo transfers in IVF.
Aims to see if Day 6 transfers are equally successful for pregnancy.
Could offer more flexibility for IVF patients and clinics.
Focuses on women having their first ICSI treatment with a single embryo transfer.
Measures pregnancy rates and miscarriage rates.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older patients could also be considered.

You must be having a specific type of IVF treatment called ICSI (Intracytoplasmic Sperm Injection), where a single embryo is transferred into your womb. Only your very first IVF cycle with these conditions will be considered for the study.

The study is only for women undergoing fertility treatment. There are no other criteria that would prevent you from joining, assuming you meet the above points.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a woman undergoing fertility treatment?
Are you having ICSI treatment?
Will you be having a single embryo transferred?
Is this your first IVF cycle (with ICSI and single embryo transfer)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be part of a group of women undergoing IVF treatment. Your treatment will be much like standard IVF, but the timing of your embryo transfer will be decided as either Day 5 or Day 6, depending on which group you're in. This won't change your visits or appointments compared to a standard IVF cycle. You will have regular follow-up scans to check for pregnancy and, if pregnancy occurs, to monitor for miscarriage. The study focuses on data collected during your IVF cycle and initial pregnancy, so the overall duration of your involvement will be similar to the length of a typical IVF journey.

Potential risks and benefits

The potential benefits of taking part could include contributing to a better understanding of IVF treatment, which might help future patients. For you personally, the treatment process will be very similar to a standard IVF cycle. There are no additional medical risks mentioned beyond those typically associated with IVF treatment, as the study is comparing two established embryo transfer timings. Remember, your participation is voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Infertility treatment center Dortmund
Verified postcode
Dortmund, Germany· Recruiting

Common questions

What is the main goal of this study?

The main goal is to find out if transferring an embryo on Day 6 is as effective as transferring it on Day 5 for getting pregnant using IVF.

Who can take part in this study?

Women aged 18 and over who are having their first ICSI treatment with a single embryo transfer can take part.

What is ICSI?

ICSI is a type of IVF where a single sperm is injected directly into an egg to help fertilisation.

Will my treatment be very different if I join?

Your IVF treatment will be largely the same as standard treatment, but the timing of your embryo transfer will be either Day 5 or Day 6 as part of the study.

Where is this study happening?

This study is running at three fertility centres in Germany: Dortmund, Essen, and Bad Münder.

How to find out more

Stefan Dieterle, MD

dieterle@kinderwunschzentrum.org 00492315575450 Official trial record

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