NAC Effect on Infertile Women With Endometrioma

NCT05460858 | Unknown Phase 3

• 1 other identifier: Royan-NAC-Genetics
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility; Endometrioma; Stress Oxidative

Keywords

en

Outcome Measures

Primary Outcomes (1)

• MII oocyte number and quality

  Observation of oocytes that were mature at the time of oocyte collection

  Immediately after oocyte puncture

Secondary Outcomes (8)

• Measurement of TAC oxidative stress marker in blood plasma

  Before intervention and 6 weeks after intervention

• Measurement of SOD oxidative stress marker in blood plasma

  Baseline and 6 weeks after intervention

• Measurement of TAC oxidative stress marker in folicular fluid

  Immediately After oocyte puncture

• Measurement of SOD oxidative stress marker in folicular fluid

  Immediately After oocyte puncture

• Cleaved embryo numbers

  2-3 days after oocyte puncture

Study Arms (2)

N-acetyl cystein

EXPERIMENTAL

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.

Drug: N-acetyl cysteine

effervescent placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

N-acetyl cysteine DRUG

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.

N-acetyl cystein

placebo DRUG

placebo

effervescent placebo

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Severe male infertility (TESE, PESA)
• Past medical history of asthma

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, 16635-148, Iran

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Endometriosis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Parvaneh Afsharian, PhD

  Royan Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parvaneh Afsharian, PhD

CONTACT

+9821- 23562000; p.afsharian@royan-rc.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: April 13, 2021
• Primary Completion: September 23, 2023
• Study Completion: November 30, 2023
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

IR (1)