Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized controlled trial comparing sequential of two shots of CFA vs CFA + rFSH for Elective Fertility Preservation. The 2-shot protocol.

This important study, called the '2-shot protocol' trial, is looking at how women can best save their eggs for future fertility. Sometimes, women choose to preserve their fertility for various reasons, and this involves collecting eggs that can be used later. The trial is comparing two slightly different ways of using hormone medicines to get the ovaries to produce eggs. One method uses two injections of a specific hormone, while the other uses one injection followed by daily doses of a different hormone. Researchers will carefully check how many healthy eggs are collected with each method and look at other important factors like how patients feel and any side effects. This is a phase 3 trial, meaning it's a key step in confirming if these approaches are effective and safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Santiago Dexeus Font Fundacio Privada

Enrolment target

194

Start

26 Oct 2023

Infertility

What is this study about?

This study is about helping women who want to save their eggs for later, which is also known as elective fertility preservation. For many reasons, women might choose to do this – perhaps they want to focus on their career first, or they haven't found a partner yet, or they have a medical condition that might affect their future fertility. Retrieving healthy eggs is a crucial step in this process.

The main aim of this trial is to compare two different ways of stimulating the ovaries to produce eggs. Both methods use hormone medications. In one method, women will receive two doses of a long-acting hormone (CFA). In the other method, women will receive one dose of that same long-acting hormone, followed by daily injections of a different hormone (rFSH). Researchers want to see which approach helps them collect more mature, healthy eggs.

By comparing these two methods, the study hopes to find the most effective and gentle way to collect eggs for future use. They will also look at other important details, such as how the body reacts to the medicines, how many eggs are collected overall, whether there are any side effects like Ovarian Hyperstimulation Syndrome (OHSS), and how patients feel about their quality of life during the treatment. This research is a key part of making fertility preservation as effective and safe as possible for women.

Key takeaways

This study compares two ways of stimulating ovaries for egg collection.
It aims to find the best method for women choosing to preserve their fertility.
Researchers will check the number of healthy eggs collected and patient well-being.
You must be an adult woman seeking elective fertility preservation to participate.
Participation involves injections, scans, egg collection, and follow-up appointments.

Who may be eligible?

This study is looking for women who are considering preserving their fertility for non-medical reasons. This means you're healthy and choosing to freeze your eggs for future use, rather than needing to do so because of a specific illness currently affecting your fertility.

You would need to be an adult, aged 18 years or older, to take part. There is no upper age limit specified, but generally, fertility preservation is discussed with women who are still in their reproductive years. You will need to be well enough to undergo the medical procedures involved in egg collection.

Beyond being an adult woman looking to preserve her fertility, specific health checks and assessments would be carried out by the study doctors to make sure it's safe and appropriate for you to participate.

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.

Am I a woman considering saving my eggs for future use?
Am I 18 years old or older?
Am I generally healthy and able to undergo medical procedures?
Do I understand that this is a research study comparing different treatment methods?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a process similar to standard egg retrieval. You would receive hormone injections to stimulate your ovaries to produce multiple eggs. The study will decide whether you receive the two-shot method or the one-shot with daily injections method. You will have regular appointments for scans and blood tests to monitor how your ovaries are responding to the medication.

Throughout the stimulation period, which typically lasts around 10-14 days, you'll visit the clinic regularly. Once your eggs are ready, you'll have a procedure to collect them. After egg collection, there will be some follow-up appointments to check on your recovery and discuss the results. You'll also be asked to complete a quality of life questionnaire at certain points. The total duration of active participation, from starting medication to final follow-up, would likely be a few weeks.

Potential risks and benefits

Taking part in this study could potentially offer you access to a cutting-edge fertility preservation method, and your contribution will help improve care for women in the future. However, there are potential risks, similar to any fertility treatment, such as discomfort from injections, side effects from hormones, or a small risk of Ovarian Hyperstimulation Syndrome (OHSS). As with any medical procedure, there are also risks associated with egg retrieval. 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 fertility preservation?

Fertility preservation means collecting and storing eggs, sperm, or reproductive tissue to use later. For women, this usually involves collecting eggs that can be frozen.

What are MII oocytes?

MII oocytes are mature eggs that are ready to be fertilised. They are the type of eggs doctors look for when collecting them for fertility treatments or preservation.

What is OHSS?

OHSS stands for Ovarian Hyperstimulation Syndrome. It's a potential side effect of fertility treatments where the ovaries become swollen and painful due to hormone stimulation. Most cases are mild, but some can be more serious.

What does a '2-shot protocol' mean?

It refers to one of the methods being tested in this study, where a specific hormone medicine (CFA) is given in two separate injections instead of just one, aiming to stimulate the ovaries effectively.

Will I have to pay to be part of the study?

Generally, clinical trials cover the costs of the study treatments and procedures. However, specific details about costs or expenses would be fully explained by the study team.