Comparing Ubiquinone and Ubiquinol for Improving IVF Outcomes

A Randomized Controlled Trial of Ubiquinone vs Ubiquinol Supplementation in Women Over Age 37 Undergoing in Vitro Fertilization.

This study is testing if a supplement called ubiquinol can help older women have better success with their first IVF cycle compared to another supplement called ubiquinone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 37 Years to 43 Years
• Sex: Female
• Sponsor: Trio Fertility (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06555575 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether ubiquinol, a reduced form of Coenzyme Q10, can enhance reproductive outcomes in older women undergoing their first in vitro fertilization (IVF) cycle, compared to the standard treatment with ubiquinone. The research focuses on the role of mitochondrial energy production in egg maturation and embryo development, particularly in women aged 37 to 43. Participants will receive either ubiquinone or ubiquinol supplements, and their reproductive outcomes will be monitored to assess the effectiveness of these interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 37 to 43 who are preparing for their first IVF cycle and meet specific hormonal and health criteria.

Not a fit: Patients with severe male factor infertility or those using donor sperm may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective supplementation option to improve fertility outcomes for older women undergoing IVF.

How similar studies have performed: Previous studies have shown potential benefits of CoQ10 supplementation in improving egg quality and reproductive outcomes, suggesting this approach may be promising.

Eligibility criteria

Inclusion Criteria:

1. Women age \>37 and \<43 years undergoing their first in vitro fertilization (IVF) cycle
2. Day 3 follicle-stimulating hormone (FSH) \<12 IU/L with serum estradiol \<250 pmol/L and normal thyroid-stimulating hormone (TSH) and Prolactin
3. Partner with semen analysis suitable for IVF or ICSI
4. Anti-müllerian hormone (AMH) \> 3 pmol/L
5. Be willing and able to provide written informed consent for the study.
6. Be an otherwise healthy female and considered eligible by the investigator to be treated with a daily dose of 225 IU Recombinant human FSH (recFSH) and 75 IU Human menopausal gonadotrophins (hMG).
7. 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)
8. Have a body mass index (BMI) ≥17.5 and ≤38 kg/m2
9. Have available ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
10. Have a normal uterine cavity (no evidence of uterine polyp or submucosal fibroid) as assessed by either saline-infused sonohysterography or by hysteroscopy within 12 months of randomization
11. Have results of clinical laboratory tests (hematology, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the investigator
12. Has a pelvic ultrasound showing no cyst ≥15 mm

Exclusion Criteria:

1. Has been diagnosed with or treated for any endocrine abnormality within 3 years prior Note: Participants with a history of clinical or subclinical hypothyroidism may be eligible if thyroid stimulating hormone levels at screening are within normal limits and the participant has been on a stable dose of thyroid replacement medication (or on no replacement therapy) for at least 8 weeks.
2. Has a prolactin level above the upper limit of normal for the central laboratory
3. Has FSH \>12.0 IU/L
4. Has a history of a full or partial resection of an ovary, including a history of ovarian cystectomy, or of any ovarian tumors limiting access to the ovary during ovum pick-up, e.g., endometriomas or teratomas measuring \>10 mm
5. Has unilateral or bilateral hydrosalpinx that communicates with the endometrial cavity on screening ultrasound or hysterosalpingography.
6. Has intramural fibroids ≥3 cm or submucosal fibroids of any size
7. Has Asherman's syndrome (untreated) or endometrial polyps that have not been resected
8. Has any congenital uterine abnormality which is associated with a decreased chance of pregnancy
9. Inadequate visualization of 1 or both ovaries
10. One or both ovaries not accessible for oocyte retrieval
11. Has a history of recurrent pregnancy losses (i.e., \>3 pregnancy losses)
12. Has a history or current evidence of human immunodeficiency virus (HIV) Note: Results obtained within 1 year prior to signing the informed consent form are considered valid.
13. Has tumors of the ovary, breast, uterus, pituitary, or hypothalamus
14. Has a history of epilepsy, thrombophilia, diabetes, untreated or inadequately treated subclinical hypothyroidism, clinically significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, or auto-immune disease requiring treatment within the last 3 years
15. Is a current smoker who smokes ≥5 cigarettes per day
16. Is assessed by the Investigator as unlikely or unable to adhere to dose and/or visit schedules

Where this trial is running

Toronto, Ontario

• Trio Fertility — Toronto, Ontario, Canada (Recruiting)

Conditions IVF; ubiquinone; ubiquinol; reproductive outcome