AuthorisedTherapeutic confirmatory (Phase III)Interventional

Transdermal testosterone pretreatment in poor responders with androgen receptor polymorphism undergoing ICSI: A Randomized Clinical Investigation.

This research trial is investigating a new approach for women who are having trouble getting pregnant and are undergoing In Vitro Fertilisation (IVF). Specifically, it's for women who have fewer eggs available (called 'low ovarian reserve') and also have a particular genetic factor that affects how their body might respond to certain hormones. The study aims to find out if using a special testosterone gel on the skin for a short time before starting IVF treatment can lead to more mature eggs being collected. More eggs might mean a better chance of successful fertilisation and pregnancy. This is a phase 3 study, meaning it's a key step to confirm if this treatment works and is safe for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Instituto Bernabeu S.L.

Enrolment target

100

Start

06 Oct 2025

low ovarian reserve according to Bologna criteria and carriers of androgen receptor polymorphism

What is this study about?

This study is designed for women who are hoping to have a baby through In Vitro Fertilisation (IVF) but are facing some specific challenges. Firstly, it focuses on women who have what's called 'low ovarian reserve'. This means that when doctors check, it seems like they have fewer eggs available than might be expected for their age. This can make stimulating the ovaries to produce eggs during IVF more difficult.

Secondly, the study is also for women who have a particular genetic difference, or 'polymorphism', in something called the androgen receptor. Androgens are male hormones, like testosterone, but they also play an important role in women's bodies, especially for egg development. How a woman's body responds to these hormones can be affected by this genetic difference, which might influence their response to IVF treatment.

The main purpose of this research is to see if applying a testosterone gel to the skin for a short period before starting IVF can help. The scientists wonder if this might 'prime' the ovaries, leading to more eggs being collected during the IVF process. Ultimately, getting more eggs could potentially improve the chances of a successful pregnancy for these women. By carefully comparing this approach to a standard treatment, the study aims to confirm if this pre-treatment is effective and safe.

Key takeaways

This study is for women with low ovarian reserve and a specific genetic factor undergoing IVF.
It tests if a testosterone gel used before IVF can increase the number of eggs collected.
You might receive the active gel or a dummy gel, decided by chance.
The study aims to improve success rates for difficult IVF cases.
Participation involves applying a gel and typical IVF monitoring.

Who may be eligible?

This study is looking for women who are at least 18 years old. There's no upper age limit, meaning older women can also take part if they meet the other requirements.

You would be considered for this study if you have been diagnosed with 'low ovarian reserve'. This is a medical term that means you have fewer eggs available in your ovaries than is typical. Your doctor would assess this using specific criteria.

Finally, to be eligible, you also need to have a specific genetic variation, called an 'androgen receptor polymorphism'. Your doctor would be able to check for this and determine if you meet this requirement for the 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 aged 18 or older?
Has your doctor told you that you have 'low ovarian reserve'?
Have you been identified as having a specific 'androgen receptor polymorphism'?
Are you planning to undergo IVF treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive the testosterone gel or a 'dummy' gel (which looks and feels the same but contains no active ingredient).

You would apply the gel to your skin as instructed for a set period before you start your IVF treatment. During your IVF cycle, you would receive standard medications to stimulate your ovaries and prevent early ovulation, similar to a regular IVF cycle. Throughout the study, the research team would monitor how you respond, including regular appointments for blood tests and ultrasound scans to track your egg development.

They will record details like how long your stimulation lasts, the dose of medication you need, and importantly, how many eggs are collected. They'll also follow your progress to see how many fertilise, how many develop into embryos, and if a pregnancy occurs. The total duration of your participation would cover the pre-treatment phase, your IVF cycle, and follow-up until a pregnancy is confirmed or not.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that the testosterone gel might increase the number of eggs collected during your IVF cycle, which could improve your chances of a successful pregnancy. This is what the researchers hope to find out. However, there's no guarantee this will happen for you, and it's also possible you could experience side effects from the testosterone gel (though usually mild and temporary, such as skin irritation). You will be closely monitored for any reactions. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 'low ovarian reserve'?

It means you have fewer eggs available in your ovaries than typically expected, which can make IVF treatment more challenging.

What is an 'androgen receptor polymorphism'?

It's a small genetic difference that can affect how your body responds to certain hormones, including testosterone, which might impact egg development.

Will I definitely get the active testosterone gel?

No, you will be randomly assigned to either receive the active testosterone gel or a dummy gel. This is to ensure fair testing of the treatment.

What is the main goal of this study?

The main goal is to see if using a testosterone gel before IVF can increase the number of eggs collected from women with low ovarian reserve and this specific genetic marker.

What phase is this study in?

This is a 'Phase 3' study, which means it's a later stage of research designed to confirm if a treatment is effective and safe for patients.