Comparing Ubiquinone with Ubiquinol for IVF
Official title: Ubiquinone vs. Ubiquinol Supplementation
A Randomized Controlled Trial of Ubiquinone vs Ubiquinol Supplementation in Women Over Age 37 Undergoing in Vitro Fertilization.
- Phase 2
- 3 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
Ubiquinone 200 Mg Oral Capsule
By mouth three times daily for three months
- Medication
Ubiquinol 100 MG Oral Capsule
By mouth three times daily for three months
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Trio Fertility
Toronto, Ontario
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → for the study.
- +Be an otherwise healthy female and considered eligible by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (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 a history or current evidence of human immunodeficiency virus (HIV) Note: Results obtained within 1 year prior to signing the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → are considered valid.
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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
- −Inadequate visualization of 1 or both ovaries
- −One or both ovaries not accessible for oocyte retrieval
- −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 assessed by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → as unlikely or unable to adhere to dose and/or visit schedules
- −Has any congenital uterine abnormality which is associated with a decreased chance of pregnancy
- −Has a history of recurrent pregnancy losses (i.e., \>3 pregnancy losses)
- −Is a current smoker who smokes ≥5 cigarettes per day
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Ubiquinone 200 Mg Oral Capsule.
Registry label: A: coQ10 A
Group B receives Ubiquinol 100 MG Oral Capsule.
Registry label: B: coQ10B
Group C receives no study treatment and is followed for comparison.
Registry label: C: Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 37 years to 43 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 90 people.
The study is currently expected to finish around January 2027.
The main measurement is taken over: Through study completion, an average of 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Fertilized oocyte percentage — measured over Through study completion, an average of 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06555575 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Ubiquinone 200 Mg Oral CapsuleDrug
By mouth three times daily for three months
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Ubiquinol 100 MG Oral CapsuleDrug
By mouth three times daily for three months
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 37 years to 43 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 37 years to 43 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through study completion, an average of 1 year..
The study as a whole is currently expected to finish around 2027-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 90 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.