Health TrialsbyHealthPanel

Ubiquinone vs. Ubiquinol Supplementation

ConditionIVF
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age37-43
SponsorTrio Fertility

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ubiquinone 200 Mg Oral Capsule

    Drug

    By mouth three times daily for three months

  • Ubiquinol 100 MG Oral Capsule

    Drug

    By mouth three times daily for three months

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: coQ10 AExperimental treatment 1 intervention
Group B: coQ10BExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fertilized oocyte percentage

The primary outcome measure will be percentage of fertilized oocytes reaching the blastocyst stage (day 5 or 6 in culture)

Time frame
Through study completion, an average of 1 year.

Secondary outcomes

1

coQ10 level

CoQ10 levels in plasma and follicular fluid

Time frame
through study completion, an average of 1 year
2

Protein structural change

Rate of structural changes occurring in proteins of the follicular fluid and granulosa (GC) or cumulus (CC) cells representing oxidative stress

Time frame
through study completion, an average of 1 year
3

MII oocyte percentage

Percentage of MII oocytes per total oocytes retrieved, normal 2PN fertilization rate

Time frame
through study completion, an average of 1 year
4

Reproductive outcome

Number of day 3 embryos and ongoing pregnancy rate

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trio Fertility

Lead sponsor

Source ClinicalTrials.gov
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