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Administration of Methylprednisolone in prevention of ovarian hyperstimulation syndrome

Administration of methylprednisolone for prevention of ovarian hyperstimulation syndrome in in-vitro fertilization cycles

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138806181141N6
Enrollment
218
Registered
2010-01-04
Start date
2009-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Ovarian Hyperstimulation Syndrome. Other obstetric conditions, not elsewhere classified

Interventions

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.
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.

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
OHSS occurrence rate. Timepoint: Until 20 days after embryos transfer (ET). Method of measurement: accordance with the Golan 5 grade system.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Mohammadi Yeganeh

Royan institute

ladankh2004@yahoo.com+98 21 2356 2307

Outcome results

None listed

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