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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
140
One hundred and forty participants randomize in the intervention and placebo groups, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction. They will be received 1200 (2×600) mg of effervescent tablets of NAC or placebo 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.
placebo
Royan Institute
Tehran, Iran
RECRUITINGMII oocyte number and quality
Observation of oocytes that were mature at the time of oocyte collection
Time frame: Immediately after oocyte puncture
Measurement of TAC oxidative stress marker in blood plasma
Plasma will be obtained for studying TAC and measure by ELISA
Time frame: Before intervention and 6 weeks after intervention
Measurement of SOD oxidative stress marker in blood plasma
Plasma will be obtained for studying SOD and measure by ELISA
Time frame: Baseline and 6 weeks after intervention
Measurement of TAC oxidative stress marker in folicular fluid
Folicular fluid will be obtained for studying TAC and measure by ELISA
Time frame: Immediately After oocyte puncture
Measurement of SOD oxidative stress marker in folicular fluid
Folicular fluid will be obtained for studying SOD and measure by ELISA
Time frame: Immediately After oocyte puncture
Cleaved embryo numbers
2-3 days embryo from fertilization
Time frame: 2-3 days after oocyte puncture
Blastocyst numbers
The stage the embryo reaches after 5 days in culture from the egg retrieval
Time frame: 5 days after oocyte puncture and sperm insemination
Clinical pregnancy rate
The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG
Time frame: 4-6 weeks after embryo transfer
Fertilization rate
Percentage of transformation of micro injected oocytes into two pronuclei embryo
Time frame: 2-5 days after sperm insemination
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