To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
To investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders
详细描述
Background There is a trend for delayed marriage and childbearing worldwide. Women undergoing in vitro fertilization (IVF) cycles are getting older. Women with advanced age are more likely to be poor ovarian responders (PORs) who have poor prognosis in IVF cycles. Numerous studies have shown that DHEA supplementation may improve IVF outcomes in PORs. Additionally, due to poor prognosis of PORs, it is quite common to combine multiple therapies instead of just one treatment. Some studies showed that CoQ10 and tocotrienol are beneficial for fertility. Thus, the aim of this study is to investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in PORs.
Objective To investigate the effect of combined DHEA, CoQ10 and Tocotrienol on PORs undergoing IVF cycles
Methods The study will be conducted from March 1st, 2022 to December 31st, 2023 in our reproductive center. We plan to enroll 120 PORs undergoing IVF cycles and divided them into four groups: (1) DHEA (n=30): 75 mg DHEA supplementation per day for three months; (2) DHEA + CoQ10 + Tocotrienol (n=30): 75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for three months; (3) Control: no supplementation. Basic characteristics, infertility history, hormone profiles and ovarian reserve will be recorded. We will recheck serum levels of DHEA-S, FSH and AMH after DHEA supplementation. Then, during the IVF cycles, cumulus cells will be collected after oocyte retrieval to analyze genes expression and mitochondrial function. We will follow reproductive outcomes after embryo transfer.
Outcome The effect of combined DHEA, CoQ10 and Tocotrienol on cumulus cells and IVF outcomes in PORs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 35~44
- •BMI18~30 kg/m2
- •Diminished ovarian reserve (AFC<5, AMH<1.2 ng/ml)
排除标准
- •Primary ovarian insufficiency
- •Congenital uterine anomaly
- •Severe intrauterine adhesion
- •Severe male factor
- •Chromosome anomaly
- •Malignancy
- •Donor cycle
- •having supplementation within 3 months
结局指标
主要结局
Ongoing pregnancy rate
时间窗: through study completion, an average of 1.75 year
continuous presence of a fetal heartbeat over 12 weeks of a pregnancy
次要结局
- mitochondrial function of cumulus cells(through study completion, an average of 1.75 year)
- Clinical pregnancy rate(through study completion, an average of 1.75 year)
研究者
Li-Te Lin
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor
Kaohsiung Veterans General Hospital.