NAC Effect on Infertile Women With Endometrioma

Phase

Condition

Infertility

Hypogonadism

Endometriosis

Treatment

N/A

Clinical Study ID

NCT05460858

Royan-NAC-Genetics

Ages 20-42
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age between 20 and 42 years
Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosisstage 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

Exclusion Criteria:

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

Study Design

April 13, 2021

November 30, 2023

Study 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.

Connect with a study center

Royan Institute
Tehran, 16635-148
Iran, Islamic Republic of
Active - Recruiting

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