Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An exploratory study to investigate the effect of FE 999302 when given together with follitropin delta during controlled ovarian stimulation

This research is looking into a new medication called FE 999302. It's being tested alongside a fertility drug called follitropin delta, which is already used in treatments like IVF (In Vitro Fertilisation). The study is for women who are having trouble getting pregnant and are undergoing assisted reproductive technologies (ART). This is an early-stage study, meaning we're mostly checking how the new medicine acts in the body and if it's safe when used with follitropin delta. The main goal is to understand if combining these medications could help improve the chances of success for women trying to conceive.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Ferring Pharmaceuticals A/S

Enrolment target

600

Start

22 May 2024

Infertility in women undergoing assisted reproductive technologies (ART)

What is this study about?

This study is about exploring a new medication, FE 999302, and how it works when given at the same time as follitropin delta. Follitropin delta is a fertility drug often used in treatments like IVF to help a woman's body produce more eggs.

We're carrying out this research because we want to find new and potentially better ways to help women who are struggling to get pregnant. The study focuses on women who are going through assisted reproductive technologies (ART), which are treatments like IVF where medical help is used to improve the chances of conception.

This is an early phase of research, sometimes called 'Human Pharmacology' or 'Phase I'. This means we're primarily focused on understanding how the new medicine behaves in the human body, how much is needed, and if it's safe when combined with an existing treatment. This kind of study helps us decide if it's worth doing larger studies in the future.

Key takeaways

This study is testing a new medicine (FE 999302) for women having fertility treatment.
It's exploring how the new medicine works with a common fertility drug (follitropin delta).
Participation involves regular checks and medical assessments.
Potential benefits include access to a new treatment, but there are also potential risks.
You must be over 18 and undergoing assisted reproductive technologies (ART).

Who may be eligible?

This study is specifically looking for women to take part. You must be at least 18 years old.

Because the study is about fertility treatments, you would need to be a woman who is currently receiving or planning to receive assisted reproductive technologies (ART), such as IVF, to help you get pregnant.

There might be other specific health requirements or conditions that would make someone suitable or unsuitable for this study. These details would be discussed with you by the study team.

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 having or planning to have fertility treatment like IVF (ART)?
Are you able to attend clinic appointments as required by the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, FE 999302, at the same time as follitropin delta, which is the fertility drug you might already be taking or planning to take. You would have regular visits to the clinic for health checks, blood tests, and possibly scans to see how your body is responding to the treatment. These visits would allow the research team to monitor your health and the effects of the medicines closely. The total duration of your participation, including any follow-up, would be explained to you by the study team.

Potential risks and benefits

Participating in research may offer the potential benefit of trying a new treatment that isn't widely available. However, there's no guarantee it will help you, and there might be side effects or risks from the new medicine or the procedures involved. These will be fully explained to you before you decide to take part. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Norway
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Unverified
Spain
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Unverified
Denmark
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Unverified
Czechia
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Unverified
Belgium

Common questions

What is ART?

ART stands for Assisted Reproductive Technologies. These are medical treatments, like IVF, designed to help people have a baby.

Is FE 999302 a new drug?

Yes, it's a new medicine being studied to understand how it works and if it can help with fertility treatment.

Will I still receive my normal fertility treatment?

Yes, FE 999302 is given alongside follitropin delta, which is a standard part of fertility treatment for many women.

How long will the study last for me?

The study team will explain the exact duration, including how long you'll take the medicine and any follow-up visits.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.