Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
1 other identifier
interventional
218
1 country
1
Brief Summary
This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 15, 2011
November 1, 2009
10 months
November 13, 2009
July 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence rate of Ovarian hyper stimulation syndrome
Until 20 days after embryos transfer
Secondary Outcomes (5)
Estradiol concentration in the day before hCG administration
Until 20 days after embryos transfer
Retrieved and injected oocytes number and quality
Until 20 days after embryos transfer
Achieved and transferred embryos number and quality
Until 20 days after embryos transfer
Implantation rate
Until 20 days after embryos transfer
Chemical and clinical pregnancy rate and cancelation rate
Until 20 days after embryos transfer
Study Arms (2)
Case
EXPERIMENTALAdministration of Methylprednisolone
Control
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Poly Cystic Ovarian Syndrome patients
- Indication for IVF/ICSI and Long Protocol ovarian stimulation
- Basal FSH≥10
- Normal BMI (20-25)
- physical health
You may not qualify if:
- Allergy to GnRH analogues, FSH and corticosteroids
- presence of heart failure, recent myocardial infarction
- Hypertension
- Diabetes mellitus
- epilepsy
- glaucoma
- hypothyroidism
- hepatic failure
- osteoporosis
- peptic ulceration
- renal impairment
- Using drugs that have interaction with corticosteroids such
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Tehran Province, 14114, Iran
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashraf Moini, MD
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
- PRINCIPAL INVESTIGATOR
Marzieh Shiva, MD
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
- PRINCIPAL INVESTIGATOR
Narges bagheri lankarani, MD
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 16, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
December 1, 2010
Last Updated
July 15, 2011
Record last verified: 2009-11