Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An exploratory study to investigate the effect of FE 999302 when given during different time periods to women undergoing controlled ovarian stimulation with follitropin delta

This study is exploring a new medicine, FE 999302, for women undergoing certain fertility treatments. These treatments often involve stimulating the ovaries to produce eggs, and women in this study will also be taking a known fertility drug called follitropin delta. The main goal is to understand if giving FE 999302 at different times during the fertility treatment process has a different effect. Researchers want to learn more about how this new medicine works and if it could potentially help women who are trying to conceive with assisted reproductive technologies (ART). This is an early-stage study, meaning it's one of the first times it's being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Ferring Pharmaceuticals A/S

Enrolment target

201

Start

17 Jun 2024

Infertility in women undergoing assisted reproductive technologies (ART)

What is this study about?

This research study is about helping women who are having fertility treatment to get pregnant. Sometimes, women need extra help to encourage their ovaries to produce eggs for procedures like IVF (In Vitro Fertilisation). This is known as 'controlled ovarian stimulation'. Women in this study will already be taking a medication called follitropin delta, which is a common fertility drug used to stimulate egg production.

The study is looking at a new, experimental medicine called FE 999302. The main goal is to understand how this new medicine works in the body and if giving it at different stages of the fertility treatment makes a difference. Researchers want to see if changing the timing of FE 999302 could potentially improve the chances for women undergoing these treatments. It's important to remember that this is an early stage (Phase I) study, which means it's one of the first times this specific medicine is being tested in people to learn about its safety and how it behaves.

By taking part, you would be helping doctors and scientists learn more about how new medicines can support fertility treatments. The information gathered from this study could help future patients who are trying to get pregnant using assisted reproductive technologies.

Key takeaways

This study explores a new medicine (FE 999302) for women having fertility treatment.
It's an early-stage study, focusing on how the medicine works and its safety.
Participants will also be taking a standard fertility drug (follitropin delta).
The study looks at treating at different times to see the effect.
You must be a woman aged 18 or over and undergoing specific fertility treatment.
Participation involves extra clinic visits and monitoring.

Who may be eligible?

This study is specifically looking for women who are at least 18 years old and are currently undergoing certain types of fertility treatment. You must be undergoing 'controlled ovarian stimulation' with a particular fertility drug called follitropin delta.

Because this study is in an early phase, there will be strict guidelines about who can and cannot take part to ensure safety. For example, you would not be able to participate if you have certain medical conditions or are taking specific medications that might interfere with the study medicine. More detailed information on eligibility would be provided by the study team.

Before you can join, the study team will ask you questions about your health and medical history to make sure the study is a safe and suitable option 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.

Are you a woman?
Are you 18 years old or older?
Are you currently having fertility treatment involving 'controlled ovarian stimulation'?
Are you taking the fertility drug called follitropin delta as part of your treatment?
Are you open to having more clinic visits and monitoring than usual?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the experimental medicine, FE 999302, at specific times during your fertility treatment. You would continue to take your follitropin delta as prescribed by your doctor. The study would involve several visits to the clinic, which might be more frequent than your usual fertility treatment appointments. During these visits, you would have medical checks, blood tests, and possibly scans to monitor your health and how the treatment is progressing.

The research team would carefully explain the exact schedule of visits, tests, and when you would take the study medicine. They would also follow up with you for a period after your main treatment ends to ensure your well-being. The total duration of your participation in the study would depend on your specific fertility treatment cycle and follow-up requirements, which would be clearly outlined to you beforehand.

Potential risks and benefits

Taking part in a clinical trial might offer you access to a new medicine that isn't widely available yet, which could potentially help your fertility treatment. However, as with any new medicine, there might be side effects or risks that are not fully known at this early stage. The research team will carefully monitor you for any problems. It's also important to remember that the new medicine may not work for everyone, or it might not work better than existing treatments. You can 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
Denmark
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Unverified
Czechia
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Unverified
Spain
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Unverified
Belgium
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Unverified
Norway

Common questions

What is 'controlled ovarian stimulation'?

It's a part of fertility treatment where medicines are given to encourage your ovaries to produce several eggs at once, instead of just one.

What is follitropin delta?

It's a common medicine used in fertility treatments to help stimulate your ovaries to develop eggs.

Is FE 999302 a proven treatment?

No, it's a new, experimental medicine being tested in an early-stage study to see how it works and if it's safe.

Will I know if I'm getting the new medicine or something else?

Because this is an early-stage study, everyone in this particular study usually receives the new medicine, but timing may differ. The researchers will explain this to you fully.

Will this study guarantee I'll get pregnant?

No, clinical trials cannot guarantee pregnancy. The aim is to gather information about the new medicine to potentially help future fertility treatments.