Not yet recruitingOBSERVATIONAL

Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study

This study explores if a special check of the womb, called uterine immune profiling, can improve the chances of having a baby for women undergoing fertility treatments like IVF. Researchers are comparing women who had this check before a single embryo transfer with those who didn't. They want to see if this profiling leads to more successful live births. The study focuses on women who received a single, day-5 embryo. They are carefully matching women based on their age, previous fertility treatment history, and the type and quality of embryo used. By doing this, they hope to understand if a personalised approach to preparing the womb can boost pregnancy success rates and reduce miscarriages.

At a glance

Status

Not yet recruiting

Sponsor

Matricelab Innove

Enrolment target

340

Start

15 Jan 2025

Estimated completion

30 May 2025

Infertility Success Rate of Assisted Reproductive Therapy Single Embryo Transfer Pregnancy Outcomes Immunological Tolerance Immune System

What is this study about?

Many couples need help to have a baby, and fertility treatments like IVF (In Vitro Fertilisation) are common. Sometimes, even with a healthy embryo, getting pregnant can be difficult. Recent research suggests that the inside lining of the womb, where the embryo needs to implant, plays a very important role. This lining has its own 'immune system' – a network of cells that can affect whether an embryo is accepted or rejected.

This study aims to find out if understanding and checking this immune system in the womb, a process called 'uterine immune profiling', can help more women have a healthy baby after fertility treatment. Because previous studies sometimes used different types of embryos or transfers, making it hard to get clear answers, this research is very specific. It focuses only on women who had a single embryo transferred when it was five days old (a 'Day 5 blastocyst').

Researchers will compare two groups of women: those who had their womb checked with immune profiling before their embryo transfer, and a carefully matched group of women who did not have this check. They will then look at how many women in each group successfully had a baby. They will also look at how many became pregnant and how many had miscarriages. This will help them understand if checking the womb's immune system can improve the overall success of fertility treatment.

Key takeaways

Study examines if a special womb check improves IVF success.
Compares women who had womb immune profiling with those who didn't.
Focuses on single Day 5 embryo transfers.
Aims to improve future fertility treatment outcomes.
Uses existing medical records, no new procedures for participants.

Who may be eligible?

You might be able to take part in this study if you are a woman between 18 and 41 years old who has had fertility treatment. Specifically, the study is looking at women who had a single embryo transferred when it was five days old after January 2018 at one of the participating fertility clinics.

One group in the study includes women who had a special check of their womb (uterine immune profiling) within nine months before their embryo transfer between January 2020 and June 2023. The other group is made up of women who had a similar single embryo transfer but did not have this womb check within the year before their transfer, between January 2018 and June 2023.

It’s important that your medical history, like your age, the number of eggs collected before, and previous embryo transfers, matches someone in the other group. Also, the type of fertility treatment you had (like IVF or frozen embryo transfer) and the quality of the embryo transferred must be similar.

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 a woman aged between 18 and 41?
Did you undergo a single Day 5 embryo transfer between 2018 and March 2024?
Did you have uterine immune profiling within nine months before your embryo transfer (if in the study group)?
Was your past fertility treatment history similar to others in the study?
Did you receive treatment at Bluets or Diaconnesse reproductive centres?

Answer every question to see your result.

What does participation involve?

This is a study that looks back at existing medical records, so you won't need to attend extra appointments, take any new medication, or undergo additional tests. Researchers will be reviewing your past treatment information from fertility clinics that took part in the study. Therefore, there are no specific visits, assessments, or follow-up actions required from you as a participant. Your overall participation duration is effectively the time it takes for researchers to gather and analyse your anonymised data. There are no direct personal implications for you once the study begins data extraction.

Potential risks and benefits

This study is reviewing existing patient data, which means there are no direct physical risks to you. Your personal information will be kept confidential and anonymised for research purposes. The potential benefit of this research is helping us understand if a special womb check can improve success rates for future fertility treatments, which could lead to better care for other women trying to conceive. As this study uses existing data, you are implicitly participating by having provided your data to the relevant clinics, but there is no active participation or withdrawal process for you.

Locations (2)

Hopital des Bluets- centre d'assistance medicale à la procreation
Verified postcode
Paris, France
Hopital des diaconnesse- Centre d'assistance medicale a la procreation
Verified postcode
Paris, France

Common questions

What is 'uterine immune profiling'?

It's a special check of the womb's lining to understand its immune system, which can affect whether an embryo implants successfully.

Why is this study only looking at 'Day 5 embryos'?

Focusing on Day 5 embryos (also called blastocysts) helps researchers get clearer results by making sure all the embryos being studied are at the same stage of development.

What does 'matched controlled study' mean?

It means researchers are carefully pairing women who had the womb check with women who didn't. They match them on key things like age and previous treatments so they can fairly compare the results.

Will I know the results of the study?

Individual results won't be shared with participants as it's a review of past records. However, the overall findings of the study will likely be published to benefit the wider medical community.

Is my personal information safe?

Yes, your medical information will be kept strictly confidential and anonymous throughout the study, meaning your name or any identifying details will not be used.

How to find out more

Nathalie Lédée, MD, PhD

nathalie.ledee@matricelabinnove.com 33681560394 Official trial record

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