NAC Effect on Infertile Women With Endometrioma

Royan Institute

Status and phase: Enrolling; Phase 3

Conditions: Female Infertility; Stress Oxidative; Endometrioma

Treatments: Drug: placebo; Drug: N-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05460858

Royan-NAC-Genetics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

N-acetyl cystein

Experimental group

Description:

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.

Treatment:

Drug: N-acetyl cysteine

effervescent placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo