RecruitingPhase 2NCT06555575

Ubiquinone vs. Ubiquinol Supplementation

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

Sponsor

Trio Fertility

Enrollment

90 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

IVF

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

Sex: FEMALEMin Age: 37 YearsMax Age: 43 Years

Inclusion Criteria12

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

Exclusion Criteria16

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
Is assessed by the Investigator as unlikely or unable to adhere to dose and/or visit schedules