Recruiting
Phase 2

Ubiquinone vs. Ubiquinol

Sponsor:

Trio Fertility

Code:

NCT06555575

Conditions

IVF

Eligibility Criteria

Sex: Female

Age: 37 - 43

Healthy Volunteers: Accepted

Interventions

Ubiquinone 200 Mg Oral Capsule

Ubiquinol 100 MG Oral Capsule

Study Details

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.

Conditions

IVF

Study ID

NCT06555575

Start date

Jan 23, 2025

Status verified date

Apr, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 37 - 43

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: coQ10 A

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

experimental: coQ10B

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

no intervention: Control

Subjects are not receiving coQ10 supplementation.

Interventions

Ubiquinone 200 Mg Oral Capsule

By mouth three times daily for three months

Ubiquinol 100 MG Oral Capsule

By mouth three times daily for three months

Primary outcome measure

  • Fertilized oocyte percentage [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts and Locations

Locations

Trio Fertility

Recruiting

Toronto, Ontario, Canada, M5G 2K4

Contacts

Principal Investigator:

Robert. F. Casper, Dr.

More Information

Sponsor

Trio Fertility

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Keywords

  • ubiquinone
  • ubiquinol
  • reproductive outcome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Trio Fertility on 2025-04-10.