NCT06555575 Ubiquinone vs. Ubiquinol Supplementation
| NCT ID | NCT06555575 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Trio Fertility |
| Condition | IVF |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-01-23 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Frequently Asked Questions
Who can join the NCT06555575 clinical trial?
This trial is open to female participants only, aged 37 Years or older, up to 43 Years, studying IVF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06555575 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06555575 currently recruiting?
Yes, NCT06555575 is actively recruiting participants. Visit ClinicalTrials.gov or contact Trio Fertility to inquire about joining.
Where is the NCT06555575 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06555575 clinical trial?
NCT06555575 is sponsored by Trio Fertility. The trial plans to enroll 90 participants.