IVFPhase 2NCT06555575
Ubiquinone vs. Ubiquinol Supplementation
A Phase 2 study testing Ubiquinone 200 Mg Oral Capsule and Ubiquinol 100 MG Oral Capsule in people with IVF, run by Trio Fertility at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- Ubiquinone 200 Mg Oral Capsule and Ubiquinol 100 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Trio Fertility
Toronto, Ontario, M5G 2K4
Robert. F. Casper, Dr., 416-506-0804 ext. 3228, casper@lunenfeld.ca
Yasaman Sadeghi, M.Sc., 416-506-0804 ext. 2268, yasamans@triofertility.com
About this study
Official title: A Randomized Controlled Trial of Ubiquinone vs Ubiquinol Supplementation in Women Over Age 37 Undergoing in Vitro Fertilization.
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.
Read the 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 reproductive aging is mitochondrial aging. Mitochondria are considered to be the batteries of the eggs and are responsible for generating energy necessary for egg and subsequent embryo development.
The egg maturation process involves a combination of many changes - all of which require energy that is provided by the mitochondria. Coenzyme Q10 (CoQ10) plays an important role as fuel in this process.
The investigators have shown that CoQ10 is needed for proper energy production by mitochondria and its addition to the diet could act as a potential treatment for egg aging.
It has been shown that in an aged mouse model, administration of CoQ10 (ubiquinone) results in improved mitochondrial energy production, more healthy embryos and more live-born pups. In clinical studies, the investigators also showed potential beneficial effects to increase the number of normal embryos from human eggs in older patients. So far, only one small study measured CoQ10 concentrations in the fluid that surrounds the eggs inside the ovaries (follicular fluid) and found significantly higher CoQ10 in the follicular fluid of normal mature eggs vs abnormal eggs. In addition, higher CoQ10 concentrations were also associated with better quality embryos. This study supports the hypothesis that CoQ10 supplementation may improve egg and embryo quality.
So far, all the research studies of CoQ10 in reproductive aging have administered a form of CoQ10 called ubiquinone. Another form of CoQ10 (ubiquinol), appears to be absorbed by the body better than ubiquinone and may have other beneficial effects in the ovary besides just increasing energy production.
- Conditions
- IVF
- Being tested
- Ubiquinone 200 Mg Oral Capsule, Ubiquinol 100 MG Oral Capsule
- Keywords
- ubiquinone, ubiquinol, reproductive outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ubiquinone 200 Mg Oral CapsuleDrug
By mouth three times daily for three months
Ubiquinol 100 MG Oral CapsuleDrug
By mouth three times daily for three months
| Study group | Role | What they receive |
|---|---|---|
| coQ10 A | Experimental | Eligible subjects will be receiving ubiquinone 200 mg prior to their in vitro fertilization (IVF) cycle. Receives: Drug: Ubiquinone 200 Mg Oral Capsule |
| coQ10B | Experimental | Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle. Receives: Drug: Ubiquinol 100 MG Oral Capsule |
| Control | No intervention | Subjects are not receiving coQ10 supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilized oocyte percentage
The primary outcome measure will be percentage of fertilized oocytes reaching the blastocyst stage (day 5 or 6 in culture)
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
coQ10 level
CoQ10 levels in plasma and follicular fluid
Measured: through study completion, an average of 1 year
Protein structural change
Rate of structural changes occurring in proteins of the follicular fluid and granulosa (GC) or cumulus (CC) cells representing oxidative stress
Measured: through study completion, an average of 1 year
MII oocyte percentage
Percentage of MII oocytes per total oocytes retrieved, normal 2PN fertilization rate
Measured: through study completion, an average of 1 year
Reproductive outcome
Number of day 3 embryos and ongoing pregnancy rate
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start23 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trio Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555575
- Sponsor's protocol ID
- K001
- Status last verified
- Apr 2025
- First submitted
- 8 Aug 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ubiquinone vs Ubiquinol Supplementation in Women Over Age 37 Undergoing in Vitro Fertilization.
- ClinicalTrials.gov ID
- NCT06555575
- Acronym / sponsor ID
- K001
- Conditions
- IVF
- Keywords
- ubiquinone, ubiquinol, reproductive outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Trio FertilityUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 reproductive aging is mitochondrial aging. Mitochondria are considered to be the batteries of the eggs and are responsible for generating energy necessary for egg and subsequent embryo development.
The egg maturation process involves a combination of many changes - all of which require energy that is provided by the mitochondria. Coenzyme Q10 (CoQ10) plays an important role as fuel in this process.
The investigators have shown that CoQ10 is needed for proper energy production by mitochondria and its addition to the diet could act as a potential treatment for egg aging.
It has been shown that in an aged mouse model, administration of CoQ10 (ubiquinone) results in improved mitochondrial energy production, more healthy embryos and more live-born pups. In clinical studies, the investigators also showed potential beneficial effects to increase the number of normal embryos from human eggs in older patients. So far, only one small study measured CoQ10 concentrations in the fluid that surrounds the eggs inside the ovaries (follicular fluid) and found significantly higher CoQ10 in the follicular fluid of normal mature eggs vs abnormal eggs. In addition, higher CoQ10 concentrations were also associated with better quality embryos. This study supports the hypothesis that CoQ10 supplementation may improve egg and embryo quality.
So far, all the research studies of CoQ10 in reproductive aging have administered a form of CoQ10 called ubiquinone. Another form of CoQ10 (ubiquinol), appears to be absorbed by the body better than ubiquinone and may have other beneficial effects in the ovary besides just increasing energy production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| coQ10 A | Experimental | Drug: Ubiquinone 200 Mg Oral CapsuleEligible subjects will be receiving ubiquinone 200 mg prior to their in vitro fertilization (IVF) cycle. |
| coQ10B | Experimental | Drug: Ubiquinol 100 MG Oral CapsuleEligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle. |
| Control | No intervention | –Subjects are not receiving coQ10 supplementation. |
Who may qualify
- Ages
- 37 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ubiquinone 200 Mg Oral CapsuleBy mouth three times daily for three months | Drug | coQ10 A |
| Ubiquinol 100 MG Oral CapsuleBy mouth three times daily for three months | Drug | coQ10B |
Primary outcome
Fertilized oocyte percentage
Time frame: Through study completion, an average of 1 year.
The primary outcome measure will be percentage of fertilized oocytes reaching the blastocyst stage (day 5 or 6 in culture)
4 secondary outcomes
coQ10 level
Time frame: through study completion, an average of 1 year
Protein structural change
Time frame: through study completion, an average of 1 year
MII oocyte percentage
Time frame: through study completion, an average of 1 year
Reproductive outcome
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ubiquinone 200 Mg Oral Capsule and Ubiquinol 100 MG Oral Capsule in people with IVF, run by Trio Fertility at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilized oocyte percentage (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.