Effect of N-acetyl Cysteine on Oxidative Stress Biochemical Factors and IVF/ICSI Outcomes in Women With Endometrioma: A Randomized, Double-blinded, Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- MII oocyte number and quality
研究概览
简要总结
Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Therefore, the use of antioxidants such as N-acetyl cysteine (NAC) may be reduced complications of endometrioma. To study this hypothesis, we designed a double-blind, randomized clinical trial study that aimed to determine the effect of N-acetyl cysteine (NAC) on stress oxidative factors and pregnancy outcomes in IVF/ICSI cycles in endometrioma patients.
详细描述
This study will be conducted at Royan institute on 140 women with endometrioma who are eligible for the study after receiving written consent. After randomization, the participants will be divided into two intervention and control groups. Then, they will be received 1200 (2×600) mg of effervescent tablets of NAC or the placebo daily during 6 weeks simultaneous to start standard long agonist or antagonist protocols for induction.
Plasma blood will be collect before intervention and at the time of egg retrieval, in addition to, follicular fluid (FF) will be obtained from the mature follicles of each ovary and will be separated by centrifuging and will be frozen until analysis. Then, we will measure the levels of two markers of oxidative stress (TAC: Total antioxidant capacity and SOD: Superoxide dismutase) in plasma and FF of all samples by enzyme-linked immunosorbent assay (ELISA) method. In addition, the pregnancy outcomes will be investigated in treated and untreated groups. Also, we will study the effect of pain severity of by visual analogue scale (VAS) technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 42 years
- •Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV)
- •Serum AMH levels between 0.7 and 4.5 ng/ml
- •Standard long GnRH and antagonist ovulation stimulation cycle
- •Body mass index (BMI) <30 kg/m2
排除标准
- •Non-inclusion criteria: Congenital uterine malformations
- •Severe male infertility (TESE, PESA)
- •Past medical history of asthma
研究组 & 干预措施
N-acetyl cystein
Seventy participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. Also, we will measure severity of dysmenorea by visual analogue scale (VAS) technique.
干预措施: N-acetyl cysteine (Drug)
effervescent placebo
Seventy participants who randomly assigned to the control group, during 6 weeks simultaneous to start the standard long agonist protocol, or antagonist induction, will be received 1200 (2×600) mg of effervescent placebo tablets daily. Plasma blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorrhea by visual analogue scale (VAS) technique.
干预措施: placebo (Drug)
结局指标
主要结局
MII oocyte number and quality
时间窗: Immediately after oocyte puncture
Observation of oocytes that were mature at the time of oocyte collection
次要结局
- Measurement of SOD oxidative stress marker in blood plasma(Baseline and 6 weeks after intervention)
- Cleaved embryo numbers(2-3 days after oocyte puncture)
- Fertilization rate(2-5 days after sperm insemination)
- Measurement of TAC oxidative stress marker in blood plasma(Before intervention and 6 weeks after intervention)
- Measurement of TAC oxidative stress marker in folicular fluid(Immediately After oocyte puncture)
- Measurement of SOD oxidative stress marker in folicular fluid(Immediately After oocyte puncture)
- Blastocyst numbers(5 days after oocyte puncture and sperm insemination)
- Clinical pregnancy rate(4-6 weeks after embryo transfer)