AuthorisedPhase III and phase IV (Integrated)Interventional

A randomised, controlled, assessor-blind, parallel groups, multicentre, multinational trial comparing the ovarian response after controlled ovarian stimulation with mixed protocols of follitropin delta (REKOVELLE) and highly purified human menopausal gonadotropin (MENOPUR) in women undergoing an assisted reproductive technology programme

This research is comparing two common hormone medicines, Rekovelle and Menopur, that are used in fertility treatments such as IVF (In Vitro Fertilisation) or ICSI (Intracytoplasmic Sperm Injection). When women go through these treatments, they need to take medicines to encourage their ovaries to produce several eggs. This study wants to find out which of these two medicines is more effective at helping women produce the right number of good-quality fertilised eggs. The main goal is to understand if one medicine leads to a better chance of success in fertility treatment for women who are having trouble conceiving.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Ferring Pharmaceuticals A/S

Enrolment target

115

Start

08 Nov 2022

Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle

What is this study about?

This research study is about helping women who are undergoing fertility treatments like IVF or ICSI. When a woman has IVF, doctors retrieve eggs from her ovaries to be fertilised in a lab. To increase the chances of success, women usually take hormone injections to stimulate their ovaries to produce many eggs.

This study is comparing two specific hormone medicines called Rekovelle and Menopur. Both are already used in fertility clinics. Researchers want to see if one of these medicines helps create more fertilised eggs (which are the first step towards a pregnancy) compared to the other. They'll be looking closely at how many eggs are successfully fertilised about a day after they've been collected.

By comparing these two treatments, the study aims to find the best way to help women produce good quality eggs, which could ultimately improve their chances of having a baby through fertility treatments. This is important work because it helps doctors understand how to give their patients the most effective care.

Key takeaways

This study compares two common IVF medicines: Rekovelle and Menopur.
It aims to find out which medicine helps produce more successfully fertilised eggs.
Participation involves your regular IVF/ICSI treatment with one of the study medicines.
It's for women aged 18 and over undergoing fertility treatment.
Results could help improve fertility treatment success rates in the future.

Who may be eligible?

This study is looking for women who are having fertility treatment. You would need to be at least 18 years old to take part. There isn't an upper age limit mentioned, but typically fertility clinics have their own age guidelines that would also apply.

This study is specifically for women who are going through assisted reproductive technologies (ART) like IVF (In Vitro Fertilization) or ICSI (Intracytoplasmic Sperm Injection). These are common types of fertility treatments where eggs and sperm are brought together outside the body.

Other specific medical details would be checked by the study doctors to make sure it's safe and appropriate for you to join. This helps ensure the study results are accurate and applies to people who are similar to 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 undergoing IVF or ICSI treatment?
Are you at least 18 years old?
Are you willing for the doctors to decide which of two medicines you receive?
Are you able to attend all required clinic appointments during your treatment cycle?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be following your usual fertility treatment plan, but with one of the two study medicines (Rekovelle or Menopur) given to you. You won't get to choose which one you receive; it will be decided by chance, like flipping a coin, to keep the study fair.

The study involves regular visits to your clinic, just as you would for standard IVF or ICSI treatment. These visits will include checks like blood tests and ultrasound scans to monitor your ovaries and egg development. You'll also receive other standard medications needed during fertility treatment, such as Fyremadel, Decapeptyl, and Ovitrelle, which help control and trigger egg release.

The most important measurement for the study will be checking how many of your eggs are successfully fertilised about 19 hours after the insemination process. The total duration of your participation would be for the length of one complete fertility treatment cycle, from starting the stimulation medicines through to egg collection and fertilisation assessment.

Potential risks and benefits

Taking part in this study could potentially benefit you by providing close monitoring and access to a well-established fertility treatment. You might also help advance medical understanding, which could improve fertility care for other women in the future. However, there's always a possibility that the treatment you receive might not work for you, just like with any fertility treatment. Potential risks are generally those already associated with IVF/ICSI treatment, such as discomfort from injections, the small risk of ovarian hyperstimulation syndrome (OHSS), or risks related to egg collection procedures. You are always free to leave the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (2)

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

—
Unverified
Italy
—
Unverified
Spain

Common questions

What is IVF/ICSI?

IVF (In Vitro Fertilisation) and ICSI (Intracytoplasmic Sperm Injection) are medical procedures to help people have a baby. Eggs are collected from the woman and fertilised with sperm outside the body, then the embryo is placed back into the womb.

What are Rekovelle and Menopur?

These are hormone medicines used in IVF/ICSI. They encourage your ovaries to produce several eggs, which increases the chances of collecting enough eggs for fertilisation.

Will I know which medicine I'm getting?

No, you won't know which medicine you're receiving. This is done by chance to make sure the study is fair and accurate, similar to how many clinical trials work.

What does 'fertilised oocytes' mean?

This refers to the eggs that have successfully joined with sperm. Doctors count these a day after fertilisation to see how well the process worked.

How long will I be in the study?

You'll be part of the study for one complete cycle of your fertility treatment, from when you start the hormone injections up until the doctors check how many of your eggs have fertilised.