AuthorisedTherapeutic use (Phase IV)Interventional

Intranasal nafarelin compared to subcutaneous triptorelin for triggering final oocyte maturation in ovarian stimulation: a non-inferiority randomised controlled clinical trial

This study, for women experiencing infertility, is comparing two different medications used in fertility treatment. It looks at Synarel, a nasal spray, and Decapeptyl, a daily injection. Both are used to help eggs mature fully before they are collected, which is a crucial step in treatments like IVF. Researchers want to know if the nasal spray works just as well as the injection in preparing eggs for collection. They will also be tracking the number of eggs collected, looking for any side effects, and checking the costs involved. This is a type of study that assesses medicines already in use to get more information about their effectiveness and safety in real-world settings.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Santiago Dexeus Font Fundacio Privada

Enrolment target

154

Start

09 Dec 2024

Infertility

What is this study about?

This clinical trial is designed for women who are going through fertility treatment because they are unable to get pregnant naturally. When undergoing fertility treatments like IVF, a key step is to encourage the ovaries to produce several eggs, and then to make sure these eggs fully mature so they can be collected and fertilised. This study is testing two different medicines that are used to trigger this final stage of egg maturation.

One medicine is Synarel, which is given as a nasal spray at a dose of 200 micrograms. The other medicine is Decapeptyl, which is given as a daily injection at a dose of 0.1 mg. Both of these drugs are already approved and widely used. The main goal of this particular study is to see if the nasal spray (Synarel) is just as effective as the daily injection (Decapeptyl) in helping to produce the right number of mature eggs, which are called MII oocytes.

Beyond simply counting the mature eggs, the study will also look at various other aspects. This includes the total number of eggs collected, if any participants develop a condition called Ovarian Hyperstimulation Syndrome (OHSS), and other possible side effects. Researchers will also be comparing the costs of using each medication. To understand how the medications work, they will measure hormone levels in the blood at different times. Importantly, they will also collect information on how participants feel about using each medication, including any pain, how easy it is to use, and which they prefer. This will help doctors and patients make more informed choices about fertility treatment options.

Key takeaways

This study compares two existing fertility drugs: Synarel nasal spray vs. Decapeptyl injection.
It aims to see which drug is better at helping eggs mature for IVF treatment.
The study measures mature eggs collected, side effects, costs, and patient experience.
Participation involves receiving one of the drugs and undergoing regular monitoring and follow-up.
It helps doctors understand more about fertility treatment options for women with infertility.

Who may be eligible?

To be able to join this study, you must be a woman aged 18 years or older who is experiencing infertility. Infertility means you've been trying to get pregnant without success.

It's important to remember that 'any' usually means there is no upper age limit for the study specifically, but individual fertility clinic guidelines and national regulations would still apply regarding age limits for fertility treatments. So, while the study itself doesn't have an upper age limit, a fertility specialist might not recommend treatment for someone over a certain age.

Beyond these basic requirements, there will be other specific health checks and criteria that a doctor or study nurse will discuss with you to make sure the study is a safe and suitable option for your unique situation.

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?
Are you 18 years old or older?
Are you currently experiencing infertility?
Are you undergoing fertility treatment where egg maturation is triggered?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. This would involve medical checks and discussions with the study team. Once enrolled, you would receive one of the two study medications, either the Synarel nasal spray or the Decapeptyl daily injection, as part of your regular fertility treatment.

Throughout the stimulation phase of your fertility cycle, you would have regular visits to the clinic for assessments. These will include blood tests to check your hormone levels and ultrasound scans to monitor your ovaries and the development of your eggs. You would also be asked about any side effects you experience and how you find using the medication.

After the eggs are collected, there would be follow-up assessments, including further blood tests. You will also be asked to share your thoughts on the pain experienced, how easy the medication was to use, and which medication you would prefer if given the choice. The total duration of your participation would cover one IVF cycle, from the start of medication until after egg collection and initial follow-up.

Potential risks and benefits

Taking part in this study could potentially offer benefits by allowing you to receive two commonly used and effective fertility medications as part of your treatment. The study aims to find the best ways to help people get pregnant, and your participation helps further this knowledge. However, as with any medical treatment, there are potential risks. These can include side effects associated with the fertility medications themselves, such as symptoms of Ovarian Hyperstimulation Syndrome (OHSS), which the study will monitor closely. You would also have additional clinic visits and blood tests compared to standard treatment. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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 the main purpose of this study?

The study aims to compare two fertility medications, a nasal spray (Synarel) and an injection (Decapeptyl), to see which is better at helping eggs mature for fertility treatment.

Who can take part in this study?

Women aged 18 or older who are experiencing infertility and are undergoing fertility treatment may be eligible.

What kind of medications will I be given?

You will be given either Synarel nasal spray or Decapeptyl as a daily injection, both used to trigger egg maturation.

Will I have extra appointments if I join?

Yes, you might have some additional clinic visits, blood tests, and scans to monitor your progress and collect study information.

Can I stop participating in the study at any point?

Yes, you are free to withdraw from the study at any time, and this will not affect your ongoing medical care.