Methylprednisolone Addition in IVF Treatment of Infertile Couples
Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles
1 other identifier
interventional
130
1 country
1
Brief Summary
Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2009
Typical duration for phase_4
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
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 14, 2010
October 1, 2010
1.9 years
August 27, 2010
October 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progesterone rise above 1.5ng.ml on the day of HCG
Incidence or high progesterone on the day of HCG triggering
up to 14 days of follicular ovarian stimulation
Secondary Outcomes (1)
Clinical pregnancy rate
Follow pregnancy until delivery
Study Arms (2)
Follicular Medrol
ACTIVE COMPARATORIn an Antagonist protocol for IVF patients will also receive 4mg tabl. Methylprednisolone twice a day from the day 2 of ovarian stimulation and until the day of the pregnancy test on luteal day-14 post oocyte retrieval
No medrol group
PLACEBO COMPARATORPatients will receive only Antagonist protocol for IVF as usual
Interventions
IVF treatment
Eligibility Criteria
You may qualify if:
- less than 36, more than 10 antral follicles, FSH\<12
You may not qualify if:
- endometriosis stage III\&IV,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitair Ziekenhuis Brussellead
- BioGenesiscollaborator
- HRGcollaborator
Study Sites (1)
Biogenesis
Thessaloniki, Pylaia, 55536, Greece
Related Publications (1)
Bider D, Menashe Y, Goldenberg M, Dulitzky M, Lifshitz A, Dor J. Dexamethasone as an adjuvant therapy for anovulatory, normoandrogenic patients during ovulation induction with exogenous gonadotropins. J Assist Reprod Genet. 1996 Sep;13(8):613-6. doi: 10.1007/BF02069638.
PMID: 8897119BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Basil Tarlatzis, Professor
BioGenesis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 27, 2010
First Posted
October 14, 2010
Study Start
January 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
October 14, 2010
Record last verified: 2010-10