Last reviewed · How we verify
NCT05460858
NAC Effect on Infertile Women With Endometrioma
Phase 3 trial testing N-acetyl cysteine in Female Infertility in 140 participants. Status unknown.
23 September 2023
Quick facts
| Lead sponsor | Royan Institute |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 140 |
| Start date | 13 April 2021 |
| Primary completion | 23 September 2023 |
| Estimated completion | 30 November 2023 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- N-acetyl cysteine
- placebo
Conditions studied
- Female Infertility — all drugs for Female Infertility →
- Endometrioma — all drugs for Endometrioma →
- Stress Oxidative — all drugs for Stress Oxidative →
Sponsor
Royan Institute
Who can join
Adults 20 to 42, female only, with Female Infertility or Endometrioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting ferroptosis opens new avenues for the development of novel therapeutics.
Sun S, Shen J, Jiang J, Wang F, et al · · 2023 · cited 380× · PMID 37735472 · DOI 10.1038/s41392-023-01606-1 -
Anti-oxidative stress treatment and current clinical trials.
Zhang CY, Yang M. · · 2024 · cited 3× · PMID 38495278 · DOI 10.4254/wjh.v16.i2.294 -
Administration of N-acetylcysteine influence the expression of apoptotic genes in the granulosa cells of infertile women diagnosed with endometriosis.
Heshmati ZS, Amiri-Yekta A, Khosravifar M, Akbarian F, et al · · 2026 · PMID 41663453 · DOI 10.1038/s41598-025-34202-0
Verify or expand the search:
- PubMed search for NCT05460858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of N-acetyl cysteine
Trials testing the same drug.
- NCT04381897 — Use of N-Acetylcysteine in the Treatment of Repetitive and Self-Injurious Behaviors in Cornelia de Lange Syndrome · Phase 2 · not yet recruiting
- NCT06836128 — The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients · Phase 3 · recruiting
- NCT06384833 — Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair · Phase 4 · not yet recruiting
- NCT06139952 — Ameliorating Contrast Induced Nephropathy After Coronary Angiography · Phase 4 · completed
- NCT06115408 — Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma · Phase 2, PHASE3 · completed
Other recruiting trials for Female Infertility
Currently open trials in the same condition.
- NCT07500337 — Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes · NA · recruiting
- NCT07394530 — Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS · NA · recruiting
- NCT07066267 — Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT) · NA · recruiting
- NCT06896747 — Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study · Phase 1, PHASE2 · recruiting
- NCT06921395 — Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulat · Phase 4 · recruiting
Other Royan Institute trials
Trials by the same sponsor.
- NCT06199024 — Cinnamon and COH in PCOS Women Underdoing IVF/ICSI Cycles · NA · unknown
- NCT06202547 — Intra-ovarian Injection of MSC-EVs in Idiopathic Premature Ovarian Failure · Phase 1, PHASE2 · unknown
- NCT04855383 — Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles · NA · completed
- NCT04600986 — Repeated Doses of GnRH Agonist as Oocyte Triggering in Antagonist Protocol for Patients With Polycystic Ovary Syndrome · NA · completed
- NCT04366063 — Mesenchymal Stem Cell Therapy for SARS-CoV-2-related Acute Respiratory Distress Syndrome · Phase 2, PHASE3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05460858 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Royan Institute
- Last refreshed: 15 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05460858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing