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泛醌与泛醇补充剂

2026年10月29日 更新者:Trio Fertility

对 37 岁以上接受体外受精的女性进行泛醌与泛醇补充剂的随机对照试验。

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

90

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5G 2K4
        • 招聘中
        • Trio Fertility
        • 接触:
        • 接触:
        • 首席研究员:
          • Robert. F. Casper, Dr.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

37年 至 43年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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

实验性的:coQ10B

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

By mouth three times daily for three months

无干预:Control

Subjects are not receiving coQ10 supplementation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fertilized oocyte percentage
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
coQ10 level
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月23日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2024年8月8日

首先提交符合 QC 标准的

2024年8月12日

首次发布 (实际的)

2024年8月15日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • K001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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