Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555575
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Ubiquinone vs Ubiquinol Supplementation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of Ubiquinone vs Ubiquinol Supplementation in Women Over Age 37 Undergoing in Vitro Fertilization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None