The Effects of Coenzyme Q10 Pretreatment on Ovarian Function and Assisted Reproductive Outcomes in Patients With Poor Ovarian Response: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
This prospective, randomized, double-blind, controlled study will be conducted at Tangdu Hospital, Air Force Medical University. It plans to enroll 128 patients with poor ovarian response for a 2-year study. The primary objective is to investigate the effects of exogenous coenzyme Q10 supplementation as pre-treatment on ovarian function and assisted reproductive clinical outcomes in patients with poor ovarian response.
Study Hypothesis: Coenzyme Q10 therapy is expected to effectively enhance ovarian function and improve assisted reproductive outcomes in patients with poor ovarian response, while demonstrating favorable safety profiles.
详细描述
This study is a prospective, randomized, double-blind, controlled clinical trial designed to investigate the effects of coenzyme Q10 pretreatment on ovarian function and assisted reproductive clinical outcomes in patients with poor ovarian response (POR). The study will be conducted at Tangdu Hospital, Air Force Medical University, with an anticipated enrollment of 128 patients meeting the Bologna diagnostic criteria for POR. Participants will be randomly assigned to either the study group (Coenzyme Q10 group) or the control group (placebo group), with 64 patients in each group.
Study Group: Guidelines for Routine Treatment + Coenzyme Q10 (Nengqilang, Yuanda Pharmaceutical) 30mg orally, 3 times/day, for 8 weeks of pretreatment. ART treatment (in vitro fertilization (IVF)) commenced in the first menstrual cycle following completion of pretreatment.
Control Group: Guidelines for Routine Treatment + placebo for 8 weeks. ART (IVF) initiated in the first menstrual cycle following treatment completion.
Primary endpoints included oocyte retrieval rate and MII oocyte rate. Secondary endpoints encompassed total GnRHA dose, stimulation duration, peak E2 level, cycle cancellation rate, fertilization rate, high-quality embryo rate, clinical pregnancy rate, and miscarriage rate. Safety was assessed by adverse reaction incidence.
The study aims to validate the efficacy and safety of Coenzyme Q10 in improving ovarian response and ART outcomes in patients with poor ovarian response through scientifically rigorous design and statistical analysis. This will provide reliable evidence-based medical support for clinical practice and contribute to enhancing women's reproductive health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals seeking IVF-ET fertility treatment;
- •Meeting the Bologna criteria for the definition of poor ovarian response (POR), specifically:
- •(1) Meeting 2 of the following 3 criteria:
- •① Presence of high-risk factors for POR;
- •② Previous cycle with ≤3 retrieved oocytes under a standard stimulation protocol;
- •③ Abnormal ovarian reserve assessment: Antral follicle count (AFC) <5 or Anti-Müllerian hormone (AMH) <1.1 ng/mL.
- •(2) Patients with normal age or ovarian reserve function who experience poor ovarian response (POR) after two consecutive cycles of maximum ovarian stimulation protocols;
- •BMI between 18.5-28.0 kg/m²
- •Voluntarily participate and sign an informed consent form.
排除标准
- •Age ≥40 years;
- •Baseline FSH >25 U/L;
- •Endocrine disorders (e.g., diabetes, thyroid disease) or autoimmune diseases (e.g., rheumatoid arthritis, lupus, Crohn's disease), chromosomal abnormalities, uterine malformations;
- •History of ovarian surgery; history of uterine surgery; adenomyosis;
- •History of more than 3 cycles of controlled ovarian stimulation (COS);
- •Male infertility;
- •Use within the past 3 months of medications that may affect ovarian reserve or ovarian responsiveness (e.g., oral contraceptives, glucocorticoids, antioxidant supplements, insulin sensitizers, DHEA, growth hormone, etc.);
- •Use of traditional Chinese medicine within the past 3 months;
- •Known allergy to Coenzyme Q10 or panthenol (water-soluble isomer of CoQ10);
- •PGT (Preimplantation Genetic Testing) population;
- •Acute or chronic renal insufficiency, hemodialysis treatment, history of severe renal impairment;
- •Infectious diseases such as HIV, active hepatitis, history of metabolic acidosis, tuberculosis;
- •Cardiovascular events within 3 months: coronary artery disease/myocardial infarction/clinically significant congestive heart failure; stroke/transient ischemic attack; deep vein thrombosis/pulmonary embolism; uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥90 mmHg); diagnosed diabetes; coronary intervention or coronary artery bypass graft surgery;
- •Neurological disorders such as dementia (e.g., Alzheimer's/Parkinson's) or use of related medications;
- •History of psychological/psychiatric disorders and use of antiepileptic, antidepressant, or similar medications;
- •History of cancer, radiation therapy, or chemotherapy;
- •Unwillingness to take supplements provided by this study;
- •Alcoholics, smokers, or individuals with substance dependence;
- •Participants in other clinical trials within the past month;
- •Patients deemed ineligible for enrollment by the investigator.
研究组 & 干预措施
Guidelines for Routine Treatment + Coenzyme Q10
Guidelines for Routine Treatment + Coenzyme Q10 (Nengqi Lang, Yunda Pharmaceutical) 30mg orally, 3 times daily, with pretreatment lasting 8 weeks. • ART treatment (in vitro fertilization (IVF)) commences during the first menstrual cycle following completion of treatment.
干预措施: Coenzyme Q10 (Dietary Supplement)
Guidelines for Routine Treatment plus placebo
Guidelines for Routine Treatment plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of oocytes retrieved
时间窗: From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).
Total number of oocytes retrieved during the oocyte retrieval procedure(unit: count).
Rate of Metaphase II (MII) Oocytes
时间窗: From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).
The proportion of mature oocytes (Metaphase II oocytes) among the total number of oocytes retrieved (unit: percentage).
次要结局
- Total Gonadotropin (Gn) Dose(From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).)
- Days of stimulation(From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).)
- Peak Estradiol (E2) Level(Assessed on the HCG trigger 1 day.)
- Cycle Cancellation Rate(From the start of ovarian stimulation until the scheduled oocyte retrieval day (up to approximately 2 weeks).)
- Fertilization rate(Day 1 after oocyte retrieval (fertilization assessment))
- Normal fertilization rate(Day 1 after oocyte retrieval (fertilization assessment))
- Cleavage Rate(Day 3 after oocyte retrieval (embryo development assessment))
- Day 3 High-Quality Embryo Rate(Day 3 after oocyte retrieval (embryo morphology scoring))
- Clinical Pregnancy Rate (First Transfer Cycle)(From pretreatment initiation until 6 weeks after the first embryo transfer.)
- Miscarriage Rate(From confirmation of clinical pregnancy until 20 weeks of gestation.)
研究者
Xiaohong Wang
Director of Obstetrics and Gynecology, Tangdu Hospital, Air Force Medical University Director of the Reproductive Medicine Center
Tang-Du Hospital