All studies
RecruitingPHASE2INTERVENTIONAL

Ubiquinone vs. Ubiquinol Supplementation

This research trial is investigating whether a certain type of supplement, Coenzyme Q10 (CoQ10), can help improve the chances of success for women aged 37-43 undergoing IVF. As women get older, the quality of their eggs can change, which is thought to be partly due to the 'batteries' of the egg cells, called mitochondria, not working as well. CoQ10 is crucial for these mitochondria to produce energy. The study will compare two different forms of CoQ10: ubiquinone and ubiquinol. Previous research has often used ubiquinone, but ubiquinol might be absorbed more easily by the body. The goal is to see if a lower dose of ubiquinol can lead to better IVF outcomes compared to the standard ubiquinone treatment.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Trio Fertility
Enrolment target
90
Start
23 Jan 2025
Estimated completion
01 Jan 2027

What is this study about?

This study is looking into a way to potentially help women aged between 37 and 43 who are trying to get pregnant using IVF (In Vitro Fertilisation). As women get older, it can sometimes be harder to conceive, and this is partly because their eggs might not be as healthy as they once were. Think of each egg cell as needing a tiny powerhouse, called a mitochondrion, to give it energy. These powerhouses are vital for the egg to mature and develop properly after fertilisation.

A natural substance called Coenzyme Q10 (CoQ10) plays a really important role in helping these mitochondria create the energy needed for healthy eggs. Researchers have found that adding CoQ10 to the diet might help improve the health of eggs in older women. Studies in animals have shown that CoQ10 can lead to healthier embryos and more successful pregnancies. In human studies, there have also been hints that CoQ10 could improve the quality of embryos. They even found higher levels of CoQ10 in the fluid around healthy eggs compared to less healthy ones.

Up until now, most research has used a form of CoQ10 called ubiquinone. However, there's another form called ubiquinol which might be absorbed into the body more easily. This study wants to see if ubiquinol, given at a lower dose, could be more effective or equally effective in improving pregnancy chances through IVF in older women, compared to the current common treatment with ubiquinone.

Key takeaways

  • This study is for women aged 37-43 undergoing their first IVF cycle.
  • It compares two forms of CoQ10 supplements, ubiquinone and ubiquinol, to see if they improve IVF outcomes.
  • CoQ10 is important for egg energy and development.
  • Ubiquinol might be absorbed better than ubiquinone.
  • You would take one type of CoQ10 orally each day during your IVF cycle.
  • Participation involves your regular IVF treatment alongside the study supplement.

Who may be eligible?

This study is specifically looking for women who are between 37 and 43 years old and are about to start their very first IVF treatment. To join, you would need to have certain hormone levels within a healthy range, and your partner's sperm (or donor sperm) must be suitable for IVF. Your Body Mass Index (BMI) should be between 17.5 and 38.

You also need to be generally healthy and willing to give your agreement to take part in the study. Your womb must be healthy, and you shouldn't have any large cysts on your ovaries. You can't join if you’ve had certain hormone problems or an ovarian surgery within the last three years, unless it's a specific thyroid condition that is well-managed.

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.

  1. Are you between 37 and 43 years old?
  2. Is this your very first IVF cycle?
  3. Are your basic hormone levels within a healthy range (FSH below 12, AMH above 3)?
  4. Do you have a healthy womb and no large ovarian cysts?
  5. Is your Body Mass Index (BMI) between 17.5 and 38?
  6. Are you generally healthy and willing to sign a consent form?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either 200mg of ubiquinone (an oral capsule) or 100mg of ubiquinol (also an oral capsule) each day. All the usual tests and procedures for IVF would continue as planned. The total duration of your participation would cover your IVF cycle from the start of medication until the outcome is known. There would be regular check-ups to monitor your progress, blood tests, and scans, similar to what you would have during a standard IVF cycle. The researchers would follow your progress and the development of your eggs and any embryos.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, as the supplements being tested might improve your chances of a successful IVF cycle, based on previous research. However, there's no guarantee it will work for everyone, and it's also possible you may not experience any direct personal benefit. As with any medication, there's a small chance of side effects from the supplements, though CoQ10 is generally considered safe. The research team will explain any known potential side effects. You are free to withdraw from the study at any time without giving a reason, which would not affect your medical care.

Locations (1)

  • Trio Fertility
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is CoQ10?

CoQ10 is a natural substance in your body that helps your cells, especially egg cells, produce the energy they need to work properly.

What's the difference between ubiquinone and ubiquinol?

They are both forms of CoQ10. Ubiquinol is thought to be absorbed by the body more easily than ubiquinone, meaning your body might be able to use it better.

Will taking these supplements guarantee I get pregnant?

No, there's no guarantee. This study is trying to find out if these supplements can improve the chances of success, but IVF outcomes can vary for many reasons.

Are there any side effects?

CoQ10 is generally well-tolerated, and serious side effects are rare. The study team will discuss any known or possible minor side effects with you.

Can I choose which supplement I get?

No, in this type of study, participants are randomly assigned to receive one type of supplement or the other. This helps make the study fair and scientific.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Ubiquinone vs. Ubiquinol Supplementation…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.