NAC Effect on Infertile Women With Endometrioma

Female Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460858
• Other study ID #: Royan-NAC-Genetics
• Status: Recruiting
• Phase: Phase 3
• Start date: April 13, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2022
• Source: Royan Institute
• Contact: Parvaneh Afsharian, PhD
• Phone: +9821- 23562000
• Email: p.afsharian[@]royan-rc.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 30, 2023
• Est. primary completion date: September 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Female Infertility
• Infertility
• Infertility, Female
• Stress Oxidative

Intervention

Drug:
• N-acetyl cysteine
One hundred and forty participants randomize in the intervention and placebo groups, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction. They will be received 1200 (2×600) mg of effervescent tablets of NAC or placebo 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.
• placebo
placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MII oocyte number and quality	Observation of oocytes that were mature at the time of oocyte collection	Immediately after oocyte puncture
Secondary	Measurement of TAC oxidative stress marker in blood plasma	Plasma will be obtained for studying TAC and measure by ELISA	Before intervention and 6 weeks after intervention
Secondary	Measurement of SOD oxidative stress marker in blood plasma	Plasma will be obtained for studying SOD and measure by ELISA	Baseline and 6 weeks after intervention
Secondary	Measurement of TAC oxidative stress marker in folicular fluid	Folicular fluid will be obtained for studying TAC and measure by ELISA	Immediately After oocyte puncture
Secondary	Measurement of SOD oxidative stress marker in folicular fluid	Folicular fluid will be obtained for studying SOD and measure by ELISA	Immediately After oocyte puncture
Secondary	Cleaved embryo numbers	2-3 days embryo from fertilization	2-3 days after oocyte puncture
Secondary	Blastocyst numbers	The stage the embryo reaches after 5 days in culture from the egg retrieval	5 days after oocyte puncture and sperm insemination
Secondary	Clinical pregnancy rate	The observation of gestational sac on ultrasound examination two-three weeks after positive serum ßhCG	4-6 weeks after embryo transfer
Secondary	Fertilization rate	Percentage of transformation of micro injected oocytes into two pronuclei embryo	2-5 days after sperm insemination