Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Exploratory study on the impact of different doses and route of administration of exogenous progesterone in artificial endometrial preparation cycles on endometrial structure and function

This study is investigating different ways to give women who are having fertility treatment a hormone called progesterone. Progesterone is really important for preparing the womb lining for a pregnancy. Researchers are exploring various doses and methods of giving this medication. They want to understand how these different approaches affect the womb lining, looking at its structure and how genes respond. The main goal is to find out which methods might be most effective in helping women who are struggling to get pregnant. This is an early-stage study, meaning it's about exploring and gathering information to guide future research.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ivi Valencia S.L., Ivi Valencia S.L.

Enrolment target

108

Start

22 Jul 2024

Female Infertility

What is this study about?

This research study is focused on a really important hormone called progesterone, especially for women who are trying to get pregnant with the help of fertility treatments. When a woman undergoes fertility treatment, her womb lining needs to be perfectly ready to accept a pregnancy. Progesterone is the hormone that helps to prepare this lining properly.

The study is looking at different ways that progesterone can be given. This includes varying the amount (dose) of the medication and how it's given, for example, by injection or as a capsule. Researchers want to see if one method works better than another in getting the womb lining just right. They are also looking very closely at how the body's genes respond to these different treatments, which can give them clues about what's happening at a very detailed level within the womb lining.

The main aim of this study is to gain a better understanding of how different progesterone treatments affect the womb lining and the body's genetic response. The hope is that by learning more, doctors can eventually improve fertility treatments and increase the chances of a successful pregnancy for women who are experiencing infertility.

Key takeaways

This study investigates different ways to give progesterone during fertility treatment.
It aims to understand how these methods affect the womb lining and genetic responses.
The goal is to improve future fertility treatment success for women with infertility.
It's a Phase II study, meaning it's an early exploration to gather information.
Participation involves receiving specific progesterone treatments and having additional tests.

Who may be eligible?

This study is designed for women who are experiencing fertility problems and are undergoing certain types of fertility treatment. You would need to be at least 18 years old to take part, and there's no upper age limit mentioned.

To be considered for this study, you would likely be a woman who is about to start a specific type of fertility treatment where your womb lining is prepared artificially, rather than through your natural cycle. Your fertility doctor can confirm if this applies to you.

There may be other specific medical requirements or exclusions that your doctor would need to check against your medical history to ensure the study is safe and suitable for you.

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.

I am a woman experiencing fertility problems.
I am at least 18 years old.
I am considering or undergoing fertility treatment using artificial womb lining preparation.
I am comfortable with the possibility of injections or specific medication dosages.
I am willing to attend additional appointments and assessments.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve receiving progesterone medication in one of the ways the researchers are testing, such as injections or capsules. This would happen as part of your planned fertility treatment cycle. You would have regular appointments for checks and assessments, including scans and possibly taking small tissue samples from your womb lining, similar to what might happen in a standard fertility work-up. Researchers would also collect blood samples. The study team would carefully explain what to do and when to take your medication. The total time you would be involved in the study would depend on your individual fertility treatment cycle and follow-up, but it's generally focused around the preparation of your womb lining.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to a better understanding of fertility treatments, which could eventually help improve success rates for women trying to get pregnant. You would also receive close medical attention during the study. Potential risks are generally associated with the procedures involved, such as discomfort from injections or biopsies, although these are common in fertility treatments. You might also experience side effects from the progesterone medication, although these are usually mild and your doctor can discuss them with you. It's very important to remember that you can decide to stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is progesterone and why is it important for fertility?

Progesterone is a natural hormone that helps prepare the womb lining for a pregnancy. In fertility treatment, it's often given to make sure the womb is ready to accept an embryo.

Will taking part in this study affect my chances of getting pregnant?

This study is designed to explore ways to improve fertility treatments. Researchers hope to learn which progesterone treatments are most effective, which could ultimately help improve your chances.

What does a 'womb lining biopsy' involve?

A womb lining biopsy is a procedure where a very small sample of the lining inside your womb is taken. It can cause some mild discomfort, similar to period cramps, but is generally quick.

Are there any extra appointments if I join the study?

There may be some additional appointments or tests compared to a standard fertility cycle, allowing the researchers to collect the necessary information for the study.

What happens after the study ends?

After your participation in the study phase finishes, your fertility treatment would continue as planned by your medical team and what is best for you.