- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06555575
Suplementación de ubiquinona versus ubiquinol
Un ensayo controlado aleatorio de suplementación con ubiquinona versus ubiquinol en mujeres mayores de 37 años sometidas a fertilización in vitro.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2K4
- Reclutamiento
- Trio Fertility
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Contacto:
- Yasaman Sadeghi, M.Sc.
- Número de teléfono: 2268 416-506-0804
- Correo electrónico: yasamans@triofertility.com
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Contacto:
- Robert. F. Casper, Dr.
- Número de teléfono: 3228 416-506-0804
- Correo electrónico: casper@lunenfeld.ca
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Investigador principal:
- Robert. F. Casper, Dr.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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 Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: coQ10 A
Eligible subjects will be receiving ubiquinone 200 mg prior to their in vitro fertilization (IVF) cycle. |
By mouth three times daily for three months |
|
Experimental: coQ10B
Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle. |
By mouth three times daily for three months |
|
Sin intervención: Control
Subjects are not receiving coQ10 supplementation. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fertilized oocyte percentage
Periodo de tiempo: 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) |
Through study completion, an average of 1 year.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
coQ10 level
Periodo de tiempo: through study completion, an average of 1 year
|
CoQ10 levels in plasma and follicular fluid |
through study completion, an average of 1 year
|
|
Protein structural change
Periodo de tiempo: through study completion, an average of 1 year
|
Rate of structural changes occurring in proteins of the follicular fluid and granulosa (GC) or cumulus (CC) cells representing oxidative stress |
through study completion, an average of 1 year
|
|
MII oocyte percentage
Periodo de tiempo: through study completion, an average of 1 year
|
Percentage of MII oocytes per total oocytes retrieved, normal 2PN fertilization rate |
through study completion, an average of 1 year
|
|
Reproductive outcome
Periodo de tiempo: through study completion, an average of 1 year
|
Number of day 3 embryos and ongoing pregnancy rate |
through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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