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Methylprednisolone Addition in IVF Treatment of Infertile Couples

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Unknown status
CT.gov ID
NCT01220791
Collaborator
BioGenesis (Industry), HRG (Other)
130
Enrollment
1
Location
2
Arms
35
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment

Condition or Disease Intervention/Treatment Phase
  • Other: In vitro fertilization treatment for infertility
 Phase 4

Detailed Description

The aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles
Study Start Date :
Jan 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Follicular Medrol

In 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

Other: In vitro fertilization treatment for infertility
IVF treatment
Other Names:
  • pregnancy
  • MEDROL
  • progesterone

    		•
    Placebo Comparator: No medrol group

    Patients will receive only Antagonist protocol for IVF as usual

    Other: In vitro fertilization treatment for infertility
    IVF treatment
    Other Names:
  • pregnancy
  • MEDROL
  • progesterone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progesterone rise above 1.5ng.ml on the day of HCG [up to 14 days of follicular ovarian stimulation]

      Incidence or high progesterone on the day of HCG triggering

    Secondary Outcome Measures

    1. Clinical pregnancy rate [Follow pregnancy until delivery]

      Success rate in IVF cycles

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 36 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • less than 36, more than 10 antral follicles, FSH<12
    Exclusion Criteria:
    • endometriosis stage III&IV,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biogenesis Thessaloniki Pylaia Greece 55536

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel
    • BioGenesis
    • HRG

    Investigators

    • Study Chair: Basil Tarlatzis, Professor, BioGenesis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01220791
    Other Study ID Numbers:
    • Medrol005
    First Posted:
    Oct 14, 2010
    Last Update Posted:
    Oct 14, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    methylprednisolone
    IVF
    progesterone
    corticosteroid
    late follicular phase
    pregnancy rates
    Additional relevant MeSH terms:
    Progesterone

    Study Results

    No Results Posted as of Oct 14, 2010