- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06555575
Supplémentation en ubiquinone et en ubiquinol
Un essai contrôlé randomisé comparant la supplémentation en ubiquinone par rapport à l'ubiquinol chez les femmes de plus de 37 ans subissant une fécondation 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M5G 2K4
- Recrutement
- Trio Fertility
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Contact:
- Yasaman Sadeghi, M.Sc.
- Numéro de téléphone: 2268 416-506-0804
- E-mail: yasamans@triofertility.com
-
Contact:
- Robert. F. Casper, Dr.
- Numéro de téléphone: 3228 416-506-0804
- E-mail: casper@lunenfeld.ca
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Chercheur principal:
- Robert. F. Casper, Dr.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: coQ10B
Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle. |
By mouth three times daily for three months |
|
Aucune intervention: Control
Subjects are not receiving coQ10 supplementation. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fertilized oocyte percentage
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
coQ10 level
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K001
Informations sur les médicaments et les dispositifs, documents d'étude
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