- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06555575
유비퀴논 대 유비퀴놀 보충
체외 수정을 받는 37세 이상의 여성을 대상으로 한 유비퀴논 대 유비퀴놀 보충의 무작위 대조 시험.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2K4
- 모병
- Trio Fertility
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연락하다:
- Yasaman Sadeghi, M.Sc.
- 전화번호: 2268 416-506-0804
- 이메일: yasamans@triofertility.com
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연락하다:
- Robert. F. Casper, Dr.
- 전화번호: 3228 416-506-0804
- 이메일: casper@lunenfeld.ca
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수석 연구원:
- Robert. F. Casper, Dr.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
실험적: coQ10B
Eligible subjects will be receiving ubiquinol 100 mg prior to their IVF cycle. |
By mouth three times daily for three months |
|
간섭 없음: Control
Subjects are not receiving coQ10 supplementation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fertilized oocyte percentage
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
coQ10 level
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .