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IRCT138806181141N6 IRCT 2010-01-04 Royan Institute Administration of Methylprednisolone in prevention of ovarian hyperstimulation syndrome Administration of methylprednisolone for prevention of ovarian hyperstimulation syndrome in in-vitro fertilization cycles 2009-10-23 anticipated 218 Complete https://irct.ir/trial/201 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 Ovarian Hyperstimulation Syndrome. Intervention 1: routine treatment for prevention of OHSS. Intervention 2: Methylprednisolone 16mg/daily orally, until 5 weeks plus 1 gm IV injection on retrieval and embryo transfer day.
public Ladan Mohammadi Yeganeh
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
Tehran Iran (Islamic Republic of) 19395-4644 +98 21 2356 2307 ladankh2004@yahoo.com Royan institute scientific Dr. Moini
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
Tehran Iran (Islamic Republic of) 19395-4644 +98 212362307 a_moini@royaninstitute.org Royan Institute Iran (Islamic Republic of) Inclusion Criteria: 1.Poly Cystic Ovarian Syndrome patients 2.Indication for IVF/ICSI and Long Protocol ovarian stimulation 3.Age<35 4.Basal FSH≥10 5.Normal BMI (20-25) 6.Physical health Exclusion Criteria: 1. Allergy to GnRH analogues, FSH and corticosteroids 2. presence of heart failure, recent myocardial infarction, Hypertension, Diabetes mellitus, epilepsy, glaucoma, hypothyroidism, hepatic failure, osteoporosis, peptic ulceration, psychosis, or severe affective disorders and renal impairment. 3. Using drugs that have interaction with corticosteroids such as Cyclosporine, Phenobarbital, Phenytoin, Rifampin, Ketoconazole, Aspirin and Anticoagulants (All of these drugs shouldn’t be used during recent 2 weeks prior to the study and during corticosteroids consumption) 18 years 35 years Female O94 , O99 Other obstetric conditions, not elsewhere classified Treatment - Drugs Treatment - Drugs routine treatment for prevention of OHSS Methylprednisolone 16mg/daily orally, until 5 weeks plus 1 gm IV injection on retrieval and embryo transfer day. OHSS occurrence rate. Timepoint: Until 20 days after embryos transfer (ET). Method of measurement: accordance with the Golan 5 grade system. Estradiol concentration. Timepoint: on the day before hCG administration. Method of measurement: laboratory results. Retrieved and injected oocytes number and quality. Timepoint: oocyte retrieval day. Method of measurement: embryology results. Achieved and transferred embryos number and quality. Timepoint: 48-72 hours after oocyte retrieval. Method of measurement: embryology results. Chemical pregnancy rate. Timepoint: day 13 after embryo transfer. Method of measurement: laboratory results. Clinical pregnancy rate. Timepoint: 4 weeks after embryo transfer. Method of measurement: Ultrasound results. Implantation rate. Timepoint: 4 weeks after embryo transfer. Method of measurement: Ultrasound results. Cancellation rate. Timepoint: day 13 after embryo transfer. Method of measurement: patient records. Royan Institute Approved 2009-07-28 Royan institute Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran Tehran Iran (Islamic Republic of)