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N-acetyl cysteine and endometrioma

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210619051619N1
Enrollment
140
Registered
2021-10-29
Start date
2021-04-13
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrioma. Endometriosis of ovary

Interventions

Intervention 1: Intervention group: Participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction, will be

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 42 Years

Inclusion criteria

Inclusion criteria: Age between 20 and 42 years old 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

Exclusion criteria: Non-inclusion criteria: Congenital uterine malformations Severe male infertility (TESE, PESA) Past medical history of asthma

Design outcomes

Primary

MeasureTime frame
MII oocyte number and quality. Timepoint: Immediately after oocyte puncture. Method of measurement: Observation of oocytes that were mature at the time of oocyte collection.

Secondary

MeasureTime frame
Measurement of TAC oxidative stress marker in blood plasma. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: ELISA.;Measurement of SOD oxidative stress marker in blood plasma. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: ELISA.;Measurement of TAC oxidative stress marker in folicular fluid. Timepoint: After oocyte puncture. Method of measurement: ELISA.;Measurement of SOD oxidative stress marker in folicular fluid. Timepoint: After oocyte puncture. Method of measurement: ELISA.;Cleaved embryo numbers. Timepoint: 2-3 days after oocyte puncture. Method of measurement: 2-3 days embryo from fertilization.;Blastocyst numbers. Timepoint: 5 days after oocyte puncture and sperm insemination. Method of measurement: The stage the embryo reaches after 5 days in culture from the egg retrieval.;Clinical pregnancy rate. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: The observation of gestational sac on ultrasound examination two-three weeks after positive serum ßhCG.;Fertilization rate. Timepoint: 2-5 days after sperm insemination. Method of measurement: Percentage of transformation of micro injected oocytes into two pronuclei embryo.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvaneh Afsharin

Royan Institute

p.afsharian@royan-rc.ac.ir+98 21 2356 2674

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026