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

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine if ubiquinol will result in improved reproductive outcomes in older women at a reduced oral dose compared to current standard treatment with ubiquinone.

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.

What data supports the effectiveness of the treatment Ubiquinol for in vitro fertilization?

Research on Coenzyme Q10 (CoQ10), which is similar to Ubiquinol, suggests it may improve egg quality and reproductive outcomes by protecting cells from damage and supporting energy production. Studies have shown that CoQ10 supplementation can reduce abnormalities in eggs and improve pregnancy rates in women undergoing fertility treatments. ^{1 2 3 4 5}

Is Coenzyme Q10 safe for use in humans?

Coenzyme Q10 (CoQ10) is generally considered safe for human use, as it has been studied in various contexts, including fertility treatments, without significant safety concerns reported. ^{1 2 3 4 6}

How does the drug Ubiquinol differ from other treatments for in vitro fertilization?

Ubiquinol, a form of Coenzyme Q10, is unique because it acts as a potent antioxidant that may improve egg quality by reducing oxidative stress in cells, which is not a focus of many standard IVF treatments. This could potentially enhance the success rates of IVF by improving the health of the eggs used in the process. ^{1 2 7 8 9}

Eligibility Criteria

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

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)

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 supplementation of human oocyte in vitro maturation reduces postmeiotic aneuploidies. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 Supplementation and Oocyte Aneuploidy in Women Undergoing IVF-ICSI Treatment. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Does coenzyme Q10 supplementation improve fertility outcomes in women undergoing assisted reproductive technology procedures? A systematic review and meta-analysis of randomized-controlled trials. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Does Coenzyme Q10 Supplementation Improve Human Oocyte Quality? [2021]

5. England pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted therapy rescues development and quality of embryos derived from oocytes matured under oxidative stress conditions: a bovine in vitro model. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 and male infertility: a meta-analysis. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

CoQ10 increases mitochondrial mass and polarization, ATP and Oct4 potency levels, and bovine oocyte MII during IVM while decreasing AMPK activity and oocyte death. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The association between coenzyme Q10 concentrations in follicular fluid with embryo morphokinetics and pregnancy rate in assisted reproductive techniques. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Supplementation with exogenous coenzyme Q10 to media for in vitro maturation and embryo culture fails to promote the developmental competence of porcine embryos. [2020]