NAC Effect on Infertile Women With Endometrioma

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    140
  • sponsor
    Royan Institute
Updated on 23 July 2022
infertility
endometrioma
oocyte retrieval

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.

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.

Details
Condition Female Infertility, Endometrioma, Stress Oxidative
Treatment Placebo, N-Acetyl Cysteine
Clinical Study IdentifierNCT05460858
SponsorRoyan Institute
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Congenital uterine malformations
Severe male infertility (TESE, PESA)
Past medical history of asthma
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