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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coQ10 A | Experimental | Eligible subjects will be receiving ubiquinone 200 mg prior to their in vitro fertilization (IVF) cycle. |
|
| coQ10B | Experimental | Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle. |
|
| Control | No Intervention | Subjects are not receiving coQ10 supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubiquinone 200 Mg Oral Capsule | Drug | By mouth three times daily for three months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilized oocyte percentage | The primary outcome measure will be percentage of fertilized oocytes reaching the blastocyst stage (day 5 or 6 in culture) | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| coQ10 level | CoQ10 levels in plasma and follicular fluid | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trio Fertility | Recruiting | Toronto | Ontario | M5G 2K4 | Canada |
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| ID | Term |
|---|---|
| D014451 | Ubiquinone |
| C003741 | ubiquinol |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
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| Ubiquinol 100 MG Oral Capsule |
| Drug |
By mouth three times daily for three months |
|
| through study completion, an average of 1 year |
| MII oocyte percentage | Percentage of MII oocytes per total oocytes retrieved, normal 2PN fertilization rate | through study completion, an average of 1 year |
| Reproductive outcome | Number of day 3 embryos and ongoing pregnancy rate | through study completion, an average of 1 year |
| D045762 |
| Enzymes and Coenzymes |