Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2021-04-13
2023-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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N-acetyl cystein
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.
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.
effervescent placebo
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.
placebo
placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe male infertility (TESE, PESA)
* Past medical history of asthma
20 Years
42 Years
FEMALE
No
Sponsors
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Royan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Parvaneh Afsharian, PhD
Role: PRINCIPAL_INVESTIGATOR
Royan Institute
Locations
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Royan Institute
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Royan-NAC-Genetics
Identifier Type: -
Identifier Source: org_study_id
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