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Clinical Cohort Study on the Endocrinology and Vaginal/Endometrial Microbiome of the Luteal Phase in Assisted Reproduction

This study is for women undergoing fertility treatment who become pregnant after transferring frozen embryos. Researchers are investigating two main things: Firstly, they want to understand when the placenta, which nourishes the baby, takes over the job of producing the important pregnancy hormone, progesterone. Currently, this exact timing is not well understood. Secondly, the study will look at the tiny germs (microbes) found in the vagina and womb. Recent research suggests these microbes might affect a woman's chances of getting and staying pregnant. By studying blood samples and swabs, the team hopes to find out how hormones and these microbes might be connected and how they influence the success and health of a pregnancy. This could help improve fertility treatments in the future.

At a glance

Status
Recruiting
Sponsor
University of Luebeck
Enrolment target
1,200
Start
02 May 2018
Estimated completion
30 Jun 2028

What is this study about?

This study focuses on an important hormone called progesterone, which is essential for a healthy pregnancy. In the early stages of pregnancy, a temporary structure called the corpus luteum, formed after ovulation, produces this hormone. However, at some point, the placenta – the organ that develops during pregnancy to feed and protect the baby – takes over the role of producing progesterone. Scientists call this switch the 'luteoplacental shift', but they don't know exactly when this happens. Understanding this timing better could help doctors support pregnancies more effectively.

The research also looks at the tiny living things, like bacteria, that naturally live in your vagina and womb. Studies are starting to show that the balance of these microbes might affect whether someone can get pregnant and stay pregnant. This study wants to see if there's a link between your hormones and these microbes, and how they both might influence how well a pregnancy progresses. By gathering this information, researchers hope to learn more about how to give pregnancies the best possible start after fertility treatments.

Ultimately, this study aims to improve our understanding of early pregnancy. It could help us identify new ways to predict how a pregnancy might develop and potentially lead to better care for women undergoing IVF or similar fertility treatments. It's an observational study, which means researchers will be carefully watching and collecting information from participants, rather than trying out new treatments.

Key takeaways

  • Researchers are studying important hormones and tiny vaginal germs.
  • This study focuses on women undergoing frozen embryo transfer.
  • It aims to understand healthy pregnancy progression after fertility treatment.
  • Participation involves routine blood and swab samples.
  • The study could help improve future fertility care.

Who may be eligible?

This study is looking for women aged between 18 and 45 years old.

You might be able to take part if you are having fertility treatment and are planning to have a frozen embryo transferred into your womb.

You would not be able to join this study if you are having a fresh embryo transfer right after an IVF cycle, or if scans show you have recently ovulated. Also, if you have any problems with the shape of your womb or other known issues with the lining of your womb, you would not be eligible to participate.

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.

  1. Are you between 18 and 45 years old?
  2. Are you having a frozen embryo transfer (not a fresh one)?
  3. Have you *not* recently ovulated (checked by scan or blood test)?
  4. Do you have a healthy womb (no known problems with its shape or lining)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would need to provide some blood samples. You would also have some simple swab tests taken from your vagina and possibly from your womb. These procedures are generally quick and, while blood draws involve a needle, they are usually well-tolerated. The researchers will be looking at your hormone levels from the blood samples and the types of germs present in the swabs.

There are no specific medications given as part of this study, as it's an observational study designed to collect information. You would continue with your usual fertility treatment plan as advised by your doctors. The researchers will collect data at the start and then during the early stages of your pregnancy, if you become pregnant. The total duration of your participation would depend on how your pregnancy progresses, but it would primarily involve a few visits for sample collection during the luteal phase and early pregnancy. You would be told exactly what would be involved at each step.

Potential risks and benefits

Taking part in this study could help scientists understand more about early pregnancy and fertility treatments, potentially leading to better care for women in the future. There are no direct medical benefits to you personally from taking part. The main risks are mild discomfort from blood sampling and vaginal/endometrial swabs, which are routine procedures. As with any study, you are free to change your mind and withdraw at any time without affecting your medical care.

Locations (5)

  • IVF-SAAR
    Verified postcode
    Saarbrücken, Germany· Recruiting
  • Universitäres Kinderwunschzentrum Lübeck
    Verified postcode
    Lübeck, Germany· Recruiting
  • Universitätsklinikum Düsseldorf,UniKiD
    Verified postcode
    Düsseldorf, Germany· Recruiting
  • Universitäres Kinderwunschzentrum
    Verified postcode
    Kiel, Germany· Recruiting
  • University of Luebeck
    Verified postcode
    Lübeck, Germany· Recruiting

Common questions

What is the main goal of this study?

The study aims to understand when the placenta takes over hormone production in early pregnancy and if vaginal germs affect pregnancy success after frozen embryo transfer.

Will I receive any new treatments?

No, this is an observational study. You will not receive any new or experimental treatments; you will continue with your usual fertility care.

What kind of samples will be taken?

You will be asked to provide blood samples and have gentle swab tests from your vagina and possibly your womb.

How long will I be in the study?

Your participation would involve a few visits for sample collection during the luteal phase and early pregnancy, if you become pregnant, following your usual treatment timeline.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care or relationship with your doctors.

How to find out more

Georg Griesinger, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Clinical Cohort Study on the Endocrinology and Vaginal/Endom…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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