AuthorisedTherapeutic exploratory (Phase II)Interventional

A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multicenter Trial Evaluating the Effects of Two Dosing Regimens of Nolasiban on Uterine Contractility and Endocrine Parameters

This research is investigating a new medicine called Nolasiban for women who are undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI). The main goal is to find out if this medicine can help to reduce how much the womb contracts, which might make it easier for a pregnancy to happen. We're also checking how the medicine affects hormones in the body. Participants will receive either Nolasiban in one of two ways, or a dummy pill (placebo). This is a 'Phase II' study, which means it's an early stage but important step to see if the treatment works and is safe. The study is for women aged 18 and over who are already planning to have IVF or ICSI.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

ReproNovo ApS

Enrolment target

120

Start

06 May 2026

Women with an indication for IVF/ICSI

What is this study about?

This study is about a new medicine called Nolasiban, which we hope could help women going through fertility treatments like IVF or ICSI. When a fertilised egg is put back into the womb, it needs a good, calm environment to settle in. Sometimes, the womb can contract (tighten), which might make it harder for the egg to implant successfully.

The main idea behind this research is to see if Nolasiban can help make the womb quieter by reducing these contractions. If the womb is calmer, it might give the embryo a better chance to attach and grow. We're also looking closely at how the medicine might affect different hormone levels in your body, as these play a big part in pregnancy.

By comparing Nolasiban to a dummy pill (placebo) and trying two different ways of giving the medicine, we hope to find the best way to use it, if it proves to be helpful. This is an important step in developing new potential treatments to support women on their fertility journey.

Key takeaways

This study is testing a new medicine (Nolasiban) for women having IVF/ICSI.
It aims to make the womb calmer to help with embryo implantation.
Participants will get either Nolasiban (two ways) or a dummy pill.
This is an early-stage study (Phase II) to check effectiveness and safety.
You must be a woman aged 18 or older and planning fertility treatment.

Who may be eligible?

This study is looking for women who are already planning to have fertility treatments like IVF (In Vitro Fertilisation) or ICSI (Intracytoplasmic Sperm Injection).

You need to be at least 18 years old to take part, and there's no upper age limit, as long as you meet all the other health requirements.

Because this medicine is designed for women's reproductive health, only women can participate in this particular study.

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 planning to have IVF or ICSI treatment?
Are you willing to take a new medicine or a dummy pill as part of research?
Are you happy to have regular check-ups and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be given either the new medicine, Nolasiban, or a dummy pill (placebo). Neither you nor your study doctor will know which you are receiving – this is to make sure the results are as fair and accurate as possible. You would take the medication for a short period, starting a few days before your embryo transfer.

Throughout the study, you'd have regular appointments where doctors will check how your womb is behaving and take blood samples to measure hormone levels. They will closely monitor you to see how your body reacts to the medicine and to ensure your safety. All these visits and tests are designed to gather important information about the study drug. You are free to withdraw from the study at any time, for any reason.

Potential risks and benefits

Taking part in this study might benefit you by giving you access to a new medicine that could potentially improve your chances of pregnancy. However, it's important to remember that it is still being tested, so there's no guarantee the medicine will work for you, or even that it will be better than the dummy pill. Like all medicines, Nolasiban might have side effects, though these will be carefully monitored. The study team will explain any known potential risks both from the medicine and from the tests you'll have, such as blood draws. You have the right to leave the study at any time, without giving a reason, and this will not affect your usual 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 IVF/ICSI?

IVF (In Vitro Fertilisation) and ICSI (Intracytoplasmic Sperm Injection) are common fertility treatments where eggs and sperm are combined outside the body to create embryos, which are then placed back into the womb.

What does 'placebo' mean?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects accurately.

Why don't I know if I'm getting the medicine or the placebo?

This is called a 'blinded' study. It's done to prevent anyone's expectations from affecting the results, making the findings more reliable and scientific.

What is 'uterine contractility'?

Uterine contractility refers to the natural tightening and relaxing of the womb muscles. In this study, we're looking to see if the medicine can help reduce these contractions, particularly around the time of embryo transfer.

Will this study affect my usual IVF/ICSI treatment?

The study aims to work alongside your planned IVF/ICSI treatment. The study team will make sure to explain how it integrates with your existing care plan.