Status:
RECRUITING
Ubiquinone vs. Ubiquinol Supplementation
Lead Sponsor:
Trio Fertility
Conditions:
IVF
Eligibility:
FEMALE
37-43 years
Phase:
PHASE2
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.
Detailed Description
As more women choose to delay child rearing, it has become increasingly important to understand why fertility declines with increasing maternal age. One of the factors suggested to play a role in repr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06555575
Start Date
January 23 2025
End Date
January 1 2027
Last Update
April 10 2025
Active Locations (1)
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1
Trio Fertility
Toronto, Ontario, Canada, M5G 2K4