Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The impact of the intensity of ovarian stimulation on embryo quality in predicted suboptimal responders. A randomized controlled trial.

This research is for women who are trying to get pregnant but are finding it difficult. It focuses on women who don't respond as well to standard fertility treatments. The study aims to compare different doses of fertility medications to see which approach works best for creating high-quality embryos. These embryos are then used in IVF (In Vitro Fertilisation) to help women get pregnant. By finding the best way to help these women, we hope to increase their chances of having a baby. The main thing we're looking at is the number of good-quality embryos that develop.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Santiago Dexeus Font Fundacio Privada

Enrolment target

110

Start

09 Sep 2024

infertility

What is this study about?

This study is about helping women who are struggling to become pregnant, particularly those who may not react as strongly to the usual fertility medications. When women go through IVF, they typically take medicines to help their ovaries produce several eggs. These eggs are then collected and fertilised in a laboratory to create embryos. The quality of these embryos is very important for a successful pregnancy.

The researchers want to see if using different amounts of fertility drugs can lead to more good-quality embryos for these women. They will compare different treatment plans to understand which one is most effective. The main goal is to find out if certain drug doses can help create more embryos that look healthy and have a better chance of developing into a baby.

Ultimately, the aim of this research is to improve fertility treatments for women who need a bit more tailored support. By understanding how different medicine strengths affect embryo quality, doctors can offer more effective options and increase the likelihood of a successful pregnancy for these women.

Key takeaways

This study helps women who find it harder to get pregnant.
It compares different amounts of fertility medicines.
The main goal is to create more good-quality embryos for IVF.
Participation involves medicines, injections, and regular checks.
You can stop participating at any time.
The aim is to improve success rates for fertility treatment.

Who may be eligible?

This study is looking for women who are at least 18 years old and are experiencing infertility. You would need to be in good general health, and your doctors would determine if you fit the specific criteria for not responding as well to fertility treatments as expected.

Your fertility specialist or a study doctor would check your medical records and ask you some questions to make sure the study is a good fit for you. They would also explain all the details of what it means to be part of this research.

It's important that you understand all the requirements before deciding to take part. This study specifically welcomes female participants.

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 female?
Are you 18 years old or older?
Are you experiencing infertility?
Has your doctor suggested you might not respond well to standard fertility treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be given one of several types of fertility medications, and the amount you receive might vary. These medications are given as injections, and some are capsules to be used vaginally. You will also take some tablet medicines.

Throughout the study, you'll have regular hospital visits for appointments and tests. These will likely include blood tests and ultrasound scans to monitor how your ovaries are responding and to check the development of your eggs. The doctors will also carefully watch how your embryos grow in the lab after fertilisation.

Your participation would involve attending all scheduled appointments and taking your medicines exactly as instructed. The total duration of your involvement would depend on your individual treatment cycle and follow-up, but the study team will let you know an estimated timeframe.

Potential risks and benefits

Taking part in this study might offer the potential benefit of finding a more effective way to create high-quality embryos for your fertility treatment, potentially increasing your chances of pregnancy. However, like all medical treatments, there are potential risks associated with fertility medications, such as side effects like discomfort, bloating, or, in rare cases, a condition called Ovarian Hyperstimulation Syndrome (OHSS). The doctors will monitor you closely for any side effects. You are always free to change your mind and withdraw from the study at any time without giving a reason, and this will not affect your future 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 does 'infertility' mean in this study?

It means you've been trying to get pregnant for a while without success, and doctors are looking for ways to improve your chances.

What are 'embryos' and why is their quality important?

Embryos are early-stage babies created when an egg and sperm join. Good quality embryos have a better chance of implanting and leading to a successful pregnancy.

Will I know which treatment I'm getting?

Because this is a 'randomized controlled trial', you might be assigned to different treatment groups, and sometimes neither you nor your doctor will know which specific treatment you are receiving until after the study is over, to keep the results fair.

What are 'fertility medications' used for?

These medicines help your ovaries produce eggs mature enough to be collected for IVF.

Is this a new type of treatment?

This is a Phase IV study, which means the medicines themselves are already approved. This study is looking at different ways of using them in specific situations.