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IRCT20210310050658N1 IRCT 2022-02-11 Zanjan University of Medical Sciences N-acetylcysteine and metformin in induction of ovulation Comparison of the adjuvant effect of N-acetylcysteine and metformin in induction of ovulation in infertile women with polycystic ovary syndrome treated with clomiphene citrate 2022-03-11 anticipated 50 Complete https://irct.ir/trial/59892 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. The size of all blocks is equal and the block size will be 6 (including 3 participants in the intervention group and 3 participants in the control group) in this two-group experiment. Random allocation software is also used to generate a random sequence of blocks, Blinding description: In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the drug prescribing protocol. 3 Polycystic ovary syndrome. Intervention 1: Intervention group: N-acetylcystein administration (produced by Shimi Daru Company)1200 mg daily in two divided doses from the first day of the cycle for 4 weeks. Intervention 2: Intervention group: Metformin (produced by Shimi Daru Company) 1500 mg daily in three divided doses from the first day of the cycle for 4 weeks. Yes - There is a plan to make this available What will be shared: Part of the data including the main and secondary outcomes can be shared. When: Access period starts from 2022 To whom: Researchers working in academic and scientific institutions Conditions: Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals. Where to obtain: Contact the research expert of the Infertility Clinic of Zanjan University to receive the required documents or data. How to obtain: To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her. Comments:
public Mozhgan Ahmadi
Infertility Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
Zanjan Iran (Islamic Republic of) 1425678552 +98 21 8806 4148 mozhganahmadi13691190@gmail.com Zanjan University of Medical Sciences scientific Mozhgan Ahmadi
Infertility Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
Zanjan Iran (Islamic Republic of) 1422356522 +98 21 8806 4148 mozhganahmadi13691990@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) aged 20-35 years infertile with polycystic ovary syndrome candidates for ovulation induction spouse with normal sperm analysis with normal hysterosalpingography without tubular pathology 20 years 35 years Female Endocrine and endocrinological diseases such as thyroid disorders and abnormal prolactin Patients who used metformin and clomiphene more frequently in the previous cycle to induce ovulation Clomiphene resistant patients Pituitary or hypothalamic disorders characterized by low gonadotropin levels Drug allergy to metformin or N Acetyl Cystein Simple ovarian cyst Liver disease E28.2 Polycystic ovary syndrome Treatment - Drugs Treatment - Drugs Intervention group: N-acetylcystein administration (produced by Shimi Daru Company)1200 mg daily in two divided doses from the first day of the cycle for 4 weeks Intervention group: Metformin (produced by Shimi Daru Company) 1500 mg daily in three divided doses from the first day of the cycle for 4 weeks Number of follicles. Timepoint: Four weeks after the intervention. Method of measurement: Transvaginal ultrasound. Endometrial thickness. Timepoint: Four weeks after the intervention. Method of measurement: Transvaginal ultrasound. Size of follicles. Timepoint: Four weeks after the intervention. Method of measurement: Transvaginal ultrasound. Frequency of intrauterine sac. Timepoint: Four weeks after the intervention. Method of measurement: Transvaginal ultrasound. Positive human chorionic gonadotropin (HCG). Timepoint: Four weeks after the intervention. Method of measurement: ELIZA test. Zanjan University of Medical Sciences Approved 2021-03-15 Ethics committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan Zanjan Zanjan Iran (Islamic Republic of)