Actively Recruiting

Phase 2
Age: 37Years - 43Years
FEMALE
Healthy Volunteers
NCT06555575

Ubiquinone vs. Ubiquinol Supplementation

Led by Trio Fertility · Updated on 2025-04-10

90

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Ubiquinone vs. Ubiquinol Supplementation

Who Can Participate

Age: 37Years - 43Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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-m�fcllerian hormone (AMH) > 3 pmol/L
  • Willing and able to provide written informed consent for the study
  • Otherwise healthy female eligible for daily 225 IU Recombinant human FSH (recFSH) and 75 IU Human menopausal gonadotrophins (hMG) treatment
  • Documented infertility for at least 12 months before randomization (except tubal infertility, severe male factor infertility, or donor sperm use)
  • Body mass index (BMI) �B117.5 and �B138 kg/m2
  • Available ejaculatory sperm (donated and/or cryopreserved sperm allowed)
  • Normal uterine cavity with no polyps or submucosal fibroids within 12 months of randomization
  • Clinical laboratory tests within normal limits or acceptable to investigator
  • Pelvic ultrasound showing no cyst �B115 mm
Not Eligible

You will not qualify if you...

  • Diagnosed or treated for any endocrine abnormality within 3 years prior (with exceptions for stable thyroid replacement therapy)
  • Prolactin level above normal
  • FSH >12.0 IU/L
  • History of full or partial ovary resection or ovarian tumors limiting ovum pick-up
  • Unilateral or bilateral hydrosalpinx communicating with endometrial cavity
  • Intramural fibroids �B13 cm or any size submucosal fibroids
  • Untreated Asherman's syndrome or unresected endometrial polyps
  • Congenital uterine abnormalities decreasing pregnancy chances
  • Inadequate visualization or inaccessibility of one or both ovaries
  • History of recurrent pregnancy losses (>3 losses)
  • History or current evidence of HIV
  • Tumors of ovary, breast, uterus, pituitary, or hypothalamus
  • History of epilepsy, thrombophilia, diabetes, untreated/inadequately treated subclinical hypothyroidism, or significant disease requiring treatment in last 3 years
  • Current smoker of 5 or more cigarettes per day
  • Assessed as unlikely or unable to adhere to dose and visit schedules

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Trio Fertility

Toronto, Ontario, Canada, M5G 2K4

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Ubiquinone vs. Ubiquinol Supplementation | DecenTrialz