RecruitingPHASE2INTERVENTIONAL

Menopur And Rekovelle Combination Study Version 2.0

This research is trying to find the best way to give fertility medicines (REKOVELLE and MENOPUR) to women having IVF. Usually, these medicines are dosed based on a hormone called AMH and weight. This study is testing if using a woman's age and weight instead can give similar good results. If successful, this could make IVF treatment more accessible, especially where AMH tests aren't routinely used. Researchers want to see if this new approach is safe and effective in helping women produce enough eggs for IVF. Over 200 women will take part, receiving personalized doses and having regular check-ups.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Clinique Ovo

Enrolment target

200

Start

04 Jul 2025

Estimated completion

01 Aug 2027

IVF Controlled Ovarian Simulation Fertility Disorders

What is this study about?

When women have In Vitro Fertilisation (IVF) to help them get pregnant, they often need special medicines to encourage their ovaries to produce several healthy eggs. This process is called 'ovarian stimulation'. Currently, doctors decide how much medicine to give based on a hormone in the blood called Anti-Müllerian Hormone (AMH) and the woman's weight. However, AMH tests aren't always available, which can make it harder for some women to access personalised IVF treatment.

This study, called 'Menopur And Rekovelle Combination Study Version 2.0', wants to see if using a woman's age and weight alone can be just as good for deciding the medicine dose. The medicines being used are REKOVELLE and MENOPUR, which are commonly used in IVF. Researchers will compare the results of this new age- and weight-based dosing method with previous findings where AMH and weight were used. The main goal is to check if this alternative dosing strategy is safe and works just as well in helping women produce enough eggs for IVF.

Ultimately, if this new way of dosing works, it could make personalised IVF treatment available to more women. This means working towards helping more people have the best chance of building their families. This study will carefully monitor participants to ensure their safety and track how well the treatment is working.

Key takeaways

Tests a new way to dose fertility medicines (REKOVELLE and MENOPUR) for IVF.
Aims to see if dosing by age and weight works as well as current methods (AMH and weight).
Could make personalised IVF treatment more accessible.
Involves regular monitoring like ultrasound scans and blood tests.
Only for women having their first IVF cycle and meeting specific criteria.
You can stop participating at any time.

Who may be eligible?

This study is looking for women aged between 18 and 40 who are having their very first IVF treatment. You might be suitable if you've been diagnosed with certain fertility issues like unexplained infertility, blocked fallopian tubes, stage I/II endometriosis, or male factor infertility. You should have regular monthly periods and both ovaries present. Also, your recent blood tests for a hormone called FSH should be within a normal range.

There are also some reasons why you wouldn't be able to join. For example, if you're planning to use donor eggs, have more severe endometriosis (stage III/IV), or a very high risk of a condition called Ovarian Hyperstimulation Syndrome (OHSS). You also can't take part if your Body Mass Index (BMI) is over 40, you've had three or more miscarriages in a row, or have certain health problems like kidney/liver issues, specific cancers, or a history of blood clots. If you're allergic to the study medicines or are in another medical research study, you wouldn't be able to join either.

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 aged between 18 and 40 years old?
Is this your very first IVF cycle?
Do you have regular monthly periods and both ovaries?
Have you been diagnosed with unexplained, tubal, early endometriosis, or male factor infertility?
Is your Body Mass Index (BMI) not over 40?
Do you have any current or past history of certain serious health conditions (e.g., specific cancers, severe endometriosis, kidney/liver issues)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a personalised dose of two fertility medicines (REKOVELLE and MENOPUR). This dose will be chosen specifically for you based on your age and weight. During your treatment, you'll have regular check-ups which include ultrasound scans to see how your ovaries are responding and blood tests to measure your hormone levels. These appointments are similar to what you'd expect during standard IVF.

Following the stimulation, you will undergo the usual IVF procedures. This includes the egg retrieval procedure where eggs are collected from your ovaries, and then the assessment of these eggs and any resulting embryos in the lab. The study will likely follow the normal timeline for an IVF cycle, which typically lasts a few weeks from the start of medication until egg retrieval and potentially embryo transfer. The duration of the study participation for each individual would be until the end of their IVF cycle.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it might help improve how personalised IVF care is given, especially for women where AMH tests aren't easily available. This could lead to more effective treatment for you and others in the future. As with all IVF treatments, there are general risks such as Ovarian Hyperstimulation Syndrome (OHSS), mild discomfort from injections, and the procedures involved. The study medicines themselves also have known side effects, which your doctor will discuss with you. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (2)

Ottawa fertility centre
Verified postcode
Ottawa, Canada· Recruiting
Clinique ovo
Verified postcode
Montreal, Canada· Recruiting

Common questions

What fertility medicines are used in this study?

The study uses a combination of two fertility medicines called REKOVELLE and MENOPUR to stimulate the ovaries.

Why is this study important?

It's trying to find a simpler way to decide the dose of fertility medicines for IVF, potentially making personalised treatment easier to access for more women.

Will my treatment be different from standard IVF?

The main difference is how your medicine dose is decided (based on age and weight). The rest of your IVF process, like monitoring and egg retrieval, will be standard.

What is the age range for participants?

Women aged between 18 and 40 years old can take part in this study.

Will I have to pay to be in the study?

The study will cover the costs associated with the specific research procedures and medicines related to the trial, but you should discuss any standard IVF costs with your clinic.

How to find out more

Marya Far

m.far@cliniqueovo.com 514-798-2000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.