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IRCT20170417033490N2 IRCT 2018-12-05 Tehran University of Medical Sciences Evaluation of oral calcium effect in prevention OHSS (ovarian hyperstimulation syndrome) in high-risk patients Evaluation of oral calcium effect versus placebo in the prevention of moderate to severe OHSS (ovarian hyperstimulation syndrome) in the high-risk patients for OHSS 2017-09-12 anticipated 150 Complete https://irct.ir/trial/30797 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization with random statistics, Blinding description: In this study, simple randomization method is used and the patients had no information about the types of drug (calcium or placebo), but the nurses and doctors had full information about the types of drug. 3 OHSS(ovarian hyperstimulation syndrome). Intervention 1: Intervention group: Patients with moderate to severe Ovarian Hyperstimulation Syndrome (OHSS) that received Calcium Carbonate 500mg orally every 12 hours for 5 days after injection of HCG or recombinant HCG. Intervention 2: Control group( Placebo group): Patients with moderate to severe OHSS that received oral placebo orally every 12 hours for 5 days after injection of HCG or recombinant HCG. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Already no program were designed for their publication
public Zahra Dehbashi
Yas hospital, ّFourth alley corner, North Ostad Nejatollahi Avenue, Karimkhan street,Tehran, Iran
Tehran Iran (Islamic Republic of) 41 +98 21 4216 0000 zddoctor1390@gmail.com Tehran University of Medical Sciences scientific Zahra Rezaee
Yas hospital, Fourth alley corner, ّّNorth Ostad Nejatolahi Avenue,Karimkhan street,Tehran,Iran
Tehran Iran (Islamic Republic of) 41 +98 21 4216 0000 zhrrezaee@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 1- Antagonist protocol for Assisted reproductive technology (ART) 2- ) 2- The number of follicles ≥ 20 mm is over 20. 3- The plasma estradiol level ≥ 2500pg/ml 16 years 45 years Female 1-patients with the endocrine disease as Diabetes mellitus, hyperprolactinemia, Cushing disease, congenital adrenal hyperplasia 2- Patients with the systemic disease as asthma, collagen vascular disease, hypercholesterolemia, cycle cell anemia 3- History of neoplasm 4-The plasma estradiol level is high (over 6000pg/ml). 5- Use of insulin-sensitization drugs 6- Patients that were required to the need to cycle cancellation. N97.0 Female infertility associated with anovulation Prevention Prevention Intervention group: Patients with moderate to severe Ovarian Hyperstimulation Syndrome (OHSS) that received Calcium Carbonate 500mg orally every 12 hours for 5 days after injection of HCG or recombinant HCG Control group( Placebo group): Patients with moderate to severe OHSS that received oral placebo orally every 12 hours for 5 days after injection of HCG or recombinant HCG Prevention of ovarian hyper stimulation syndrome. Timepoint: 7 to 14 days after administration of drug. Method of measurement: physical exam, transvaginal sonography and blood exam. Tehran University of Medical Sciences Approved 2017-09-11 Ethics committee ̓s Tehran university of medical sciences Buiding (N:1),The Northern Gate of university,Poursina Ave, Ghods Ave, Enghelab St,Tehran,Iran. Tehran Tehran Iran (Islamic Republic of)