Clinical trial NCT05460858: NAC Effect on Infertile Women With Endometrioma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Female Infertility
Endometrioma
Stress Oxidative
Keywords: en
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2022-07-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Non-inclusion criteria: Congenital uterine malformations
* Severe male infertility (TESE, PESA)
* Past medical history of asthma

Primary outcomes:
measure: MII oocyte number and quality
timeFrame: Immediately after oocyte puncture
Secondary outcomes:
measure: Measurement of TAC oxidative stress marker in blood plasma
timeFrame: Before intervention and 6 weeks after intervention
measure: Measurement of SOD oxidative stress marker in blood plasma
timeFrame: Baseline and 6 weeks after intervention
measure: Measurement of TAC oxidative stress marker in folicular fluid
timeFrame: Immediately After oocyte puncture
measure: Measurement of SOD oxidative stress marker in folicular fluid
timeFrame: Immediately After oocyte puncture
measure: Cleaved embryo numbers
timeFrame: 2-3 days after oocyte puncture
measure: Blastocyst numbers
timeFrame: 5 days after oocyte puncture and sperm insemination
measure: Clinical pregnancy rate
timeFrame: 4-6 weeks after embryo transfer
measure: Fertilization rate
timeFrame: 2-5 days after sperm insemination
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Royan Institute
name: Parvaneh Afsharian, PhD
role: PRINCIPAL_INVESTIGATOR
References: