NAC Effect on Infertile Women With Endometrioma

Phase 3

• Conditions: Female Infertility; Endometrioma; Stress Oxidative
• Interventions: Drug: placebo; Drug: N-acetyl cysteine

• Registration Number: NCT05460858
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Study Start: 2021-04-13
• Status Verified: 2022-07
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15
• Primary Completion: 2023-09-23
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
effervescent placebo	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.
N-acetyl cystein	N-acetyl cysteine	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.

Primary Outcome Measures

Name	Time	Method
MII oocyte number and quality	Immediately after oocyte puncture	Observation of oocytes that were mature at the time of oocyte collection

Secondary Outcome Measures

Name	Time	Method
Measurement of SOD oxidative stress marker in blood plasma	Baseline and 6 weeks after intervention	Plasma will be obtained for studying SOD and measure by ELISA
Cleaved embryo numbers	2-3 days after oocyte puncture	2-3 days embryo from fertilization
Measurement of TAC oxidative stress marker in blood plasma	Before intervention and 6 weeks after intervention	Plasma will be obtained for studying TAC and measure by ELISA
Measurement of TAC oxidative stress marker in folicular fluid	Immediately After oocyte puncture	Folicular fluid will be obtained for studying TAC and measure by ELISA
Measurement of SOD oxidative stress marker in folicular fluid	Immediately After oocyte puncture	Folicular fluid will be obtained for studying SOD and measure by ELISA
Blastocyst numbers	5 days after oocyte puncture and sperm insemination	The stage the embryo reaches after 5 days in culture from the egg retrieval
Clinical pregnancy rate	4-6 weeks after embryo transfer	The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG
Fertilization rate	2-5 days after sperm insemination	Percentage of transformation of micro injected oocytes into two pronuclei embryo

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of