Ubiquinone vs. Ubiquinol Supplementation

NCT06555575 | Recruiting Phase 2

• 1 other identifier: K001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

ubiquinone; ubiquinol; reproductive outcome

Outcome Measures

Primary Outcomes (1)

• Fertilized oocyte percentage

  The primary outcome measure will be percentage of fertilized oocytes reaching the blastocyst stage (day 5 or 6 in culture)

  Through study completion, an average of 1 year.

Secondary Outcomes (4)

• coQ10 level

  through study completion, an average of 1 year

• Protein structural change

  through study completion, an average of 1 year

• MII oocyte percentage

  through study completion, an average of 1 year

• Reproductive outcome

  through study completion, an average of 1 year

Study Arms (3)

coQ10 A

EXPERIMENTAL

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

Drug: Ubiquinone 200 Mg Oral Capsule

coQ10B

EXPERIMENTAL

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

Drug: Ubiquinol 100 MG Oral Capsule

Control

NO INTERVENTION

Subjects are not receiving coQ10 supplementation.

Interventions

Ubiquinone 200 Mg Oral Capsule DRUG

By mouth three times daily for three months

coQ10 A

Ubiquinol 100 MG Oral Capsule DRUG

By mouth three times daily for three months

coQ10B

Eligibility Criteria

• Age: 37 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women age \>37 and \<43 years undergoing their first in vitro fertilization (IVF) cycle
• Day 3 follicle-stimulating hormone (FSH) \<12 IU/L with serum estradiol \<250 pmol/L and normal thyroid-stimulating hormone (TSH) and Prolactin
• Partner with semen analysis suitable for IVF or ICSI
• Anti-müllerian hormone (AMH) \> 3 pmol/L
• Be willing and able to provide written informed consent for the study.
• 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).
• 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)
• Have a body mass index (BMI) ≥17.5 and ≤38 kg/m2
• Have available ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
• 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
• Have results of clinical laboratory tests (hematology, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the investigator
• Has a pelvic ultrasound showing no cyst ≥15 mm

You may not qualify if:

• 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.
• Has a prolactin level above the upper limit of normal for the central laboratory
• Has FSH \>12.0 IU/L
• 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
• Has unilateral or bilateral hydrosalpinx that communicates with the endometrial cavity on screening ultrasound or hysterosalpingography.
• Has intramural fibroids ≥3 cm or submucosal fibroids of any size
• Has Asherman's syndrome (untreated) or endometrial polyps that have not been resected
• Has any congenital uterine abnormality which is associated with a decreased chance of pregnancy
• Inadequate visualization of 1 or both ovaries
• One or both ovaries not accessible for oocyte retrieval
• Has a history of recurrent pregnancy losses (i.e., \>3 pregnancy losses)
• 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.
• Has tumors of the ovary, breast, uterus, pituitary, or hypothalamus
• 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
• Is a current smoker who smokes ≥5 cigarettes per day

Sponsors & Collaborators

• Trio Fertility: lead

Study Sites (1)

Trio Fertility

Toronto, Ontario, M5G 2K4, Canada

RECRUITING

MeSH Terms

Interventions

Ubiquinone; ubiquinol

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 15, 2024
• Study Start: January 23, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CA (1)