Ubiquinone vs. Ubiquinol for In Vitro Fertilization

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Trio Fertility

Disqualifiers: Endocrine abnormality, Prolactin level, Ovarian surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ubiquinol, a form of CoQ10, can improve outcomes for women undergoing in vitro fertilization (IVF). It compares the effects of a lower dose of ubiquinol to the standard treatment with ubiquinone. The researchers aim to determine if the new treatment enhances reproductive success in older women. Women who have faced infertility for at least a year and are preparing for their first IVF attempt might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant fertility advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on thyroid replacement medication, you must have been on a stable dose for at least 8 weeks to be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both ubiquinol and ubiquinone, forms of CoQ10, are generally safe for use in fertility treatments. Studies have found that they can improve egg quality during in vitro fertilization (IVF) without causing serious side effects.

Past patients have found ubiquinol to be an effective and safe supplement in IVF treatments, particularly for women with aging ovaries. Previous studies have shown it to be well-tolerated.

Research suggests that ubiquinone can boost reproductive health by reducing harmful molecules known as free radicals. This indicates it is also safe and well-tolerated in similar situations.

Since this trial is in Phase 2, earlier phases have already evaluated the treatment's safety, showing a reasonable expectation of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because ubiquinol and ubiquinone, both forms of CoQ10, may enhance the success of in vitro fertilization (IVF) by improving egg quality. Unlike other options for fertility enhancement, ubiquinol is the more active form of CoQ10, which means it's more easily absorbed by the body. This could potentially lead to better outcomes compared to ubiquinone, which is converted into ubiquinol in the body. By directly supplying ubiquinol, researchers hope to boost energy production within cells more efficiently, possibly leading to higher IVF success rates.

What evidence suggests that this trial's treatments could be effective for in vitro fertilization?

This trial will compare the effects of two forms of CoQ10, ubiquinol and ubiquinone, on in vitro fertilization (IVF) outcomes. Studies have shown that CoQ10 can improve egg quality during IVF treatments. Research suggests that taking CoQ10 before treatment might help women with aging ovaries achieve better IVF results, such as higher chances of pregnancy and fewer problems with egg quality. However, some studies found that while CoQ10 can improve egg quality, it might not increase the number of eggs collected. Both forms, ubiquinol and ubiquinone, have been studied for their antioxidant effects, which help protect cells during IVF. Participants in this trial will receive either ubiquinol or ubiquinone prior to their IVF cycle, or no CoQ10 supplementation as part of the control group. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Women aged >37 and <43 undergoing their first IVF cycle, with a history of infertility but normal reproductive health markers. They must have a BMI between 17.5 and 38, non-smokers, no significant medical conditions or ovarian issues that would affect egg retrieval, and partners with suitable semen for IVF.

Inclusion Criteria

Anti-müllerian hormone (AMH) > 3 pmol/L

Documented history of infertility for at least 12 months before randomization (not applicable in case of tubal infertility or severe male factor infertility, or when the use of donor sperm is indicated)

My uterine cavity is normal, with no polyps or fibroids as confirmed by a recent exam.

Exclusion Criteria

Has FSH >12.0 IU/L

I have untreated Asherman's syndrome or unremoved endometrial polyps.

My ovaries cannot be used for egg collection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ubiquinol 100 mg or ubiquinone 200 mg prior to their IVF cycle

Up to 1 year

Follow-up

Participants are monitored for reproductive outcomes and CoQ10 levels

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ubiquinol

Trial Overview The trial is testing if ubiquinol at a lower dose improves reproductive outcomes in older women compared to the standard treatment with ubiquinone during IVF cycles.

How Is the Trial Designed?

Group I: coQ10B Experimental Treatment 1 Intervention

Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle.

Group II: coQ10 A Experimental Treatment 1 Intervention

Eligible subjects will be receiving ubiquinone 200 mg prior to their in vitro fertilization (IVF) cycle.

Group III: Control Active Control 1 Intervention

Subjects are not receiving coQ10 supplementation.

Who Is Running the Clinical Trial?

Trio Fertility

Lead Sponsor

Trials

3

Recruited

220+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7550497/

Does coenzyme Q10 supplementation improve fertility ... Oral CoQ10 supplementation in women with POR undergoing IVF-ICSI resulted in no increase in the number of oocytes retrieved when compared with no-treatment ( ...

2. frontiersin.org frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2025.1633166/full

Exploring the protective effects of coenzyme Q10 on female ... Importantly, studies have shown that CoQ10 can enhance the quality of eggs during in vitro fertilization and embryo transfer (IVF-ET) treatment ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001078

Antioxidants and Fertility in Women with Ovarian Aging Our subgroup analyses emphasize that coenzyme Q10 is a promising choice to rescue the decline in fertility caused by ovarian aging, and the optimal treatment ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2024.2389469

Clinical evidence of coenzyme Q10 pretreatment for ... Conclusions. These findings suggested that CoQ10 pretreatment is an effective intervention in improving IVF/ICSI outcomes for women with DOR.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01048385?cond=IVF%20and%20aneuploidy&rank=3

The Effect of Co Enzyme Q10 Together With Fertility Drugs ... The goal of our research is to increase live birth rates in infertile women and to reduce the incidence of aneuploidy leading to miscarriage and trisomies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12425901/

Exploring the protective effects of coenzyme Q10 on female ... Importantly, studies have shown that CoQ10 can enhance the quality of eggs during in vitro fertilization and embryo transfer (IVF-ET) treatment, ...

7. pnwfertility.com pnwfertility.com/post/coq10-and-fertility

Coq10 and Fertility Studies have found that women with higher CoQ10 levels tend to have better embryo quality, higher fertilization rates, and more successful pregnancies, ...