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Administration of Methylprednisolone in prevention of ovarian hyperstimulation syndrome

Phase 3
Conditions
Ovarian Hyperstimulation Syndrome.
Other obstetric conditions, not elsewhere classified
O94 , O99
Registration Number
IRCT138806181141N6
Lead Sponsor
Royan Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
218
Inclusion Criteria

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)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
OHSS occurrence rate. Timepoint: Until 20 days after embryos transfer (ET). Method of measurement: accordance with the Golan 5 grade system.
Secondary Outcome Measures
NameTimeMethod
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.
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