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Ubiquinon versus ubiquinol-suppletie

29 oktober 2026 bijgewerkt door: Trio Fertility

Een gerandomiseerde gecontroleerde studie van ubiquinon versus ubiquinol-suppletie bij vrouwen ouder dan 37 jaar die in vitro fertilisatie ondergaan.

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Ontario
      • Toronto, Ontario, Canada, M5G 2K4
        • Werving
        • Trio Fertility
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Robert. F. Casper, Dr.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

37 jaar tot 43 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  1. Women age >37 and <43 years undergoing their first in vitro fertilization (IVF) cycle
  2. Day 3 follicle-stimulating hormone (FSH) <12 IU/L with serum estradiol <250 pmol/L and normal thyroid-stimulating hormone (TSH) and Prolactin
  3. Partner with semen analysis suitable for IVF or ICSI
  4. Anti-müllerian hormone (AMH) > 3 pmol/L
  5. Be willing and able to provide written informed consent for the study.
  6. 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).
  7. 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)
  8. Have a body mass index (BMI) ≥17.5 and ≤38 kg/m2
  9. Have available ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
  10. 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
  11. Have results of clinical laboratory tests (hematology, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the investigator
  12. Has a pelvic ultrasound showing no cyst ≥15 mm

Exclusion Criteria:

  1. 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.
  2. Has a prolactin level above the upper limit of normal for the central laboratory
  3. Has FSH >12.0 IU/L
  4. 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
  5. Has unilateral or bilateral hydrosalpinx that communicates with the endometrial cavity on screening ultrasound or hysterosalpingography.
  6. Has intramural fibroids ≥3 cm or submucosal fibroids of any size
  7. Has Asherman's syndrome (untreated) or endometrial polyps that have not been resected
  8. Has any congenital uterine abnormality which is associated with a decreased chance of pregnancy
  9. Inadequate visualization of 1 or both ovaries
  10. One or both ovaries not accessible for oocyte retrieval
  11. Has a history of recurrent pregnancy losses (i.e., >3 pregnancy losses)
  12. 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.
  13. Has tumors of the ovary, breast, uterus, pituitary, or hypothalamus
  14. 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
  15. Is a current smoker who smokes ≥5 cigarettes per day
  16. Is assessed by the Investigator as unlikely or unable to adhere to dose and/or visit schedules

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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

Experimenteel: coQ10B

Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle.

By mouth three times daily for three months

Geen tussenkomst: Control

Subjects are not receiving coQ10 supplementation.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fertilized oocyte percentage
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
coQ10 level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 januari 2025

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

8 augustus 2024

Eerst ingediend dat voldeed aan de QC-criteria

12 augustus 2024

Eerst geplaatst (Werkelijk)

15 augustus 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

29 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • K001

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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