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Methylprednisolone Addition in IVF Treatment of Infertile Couples

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Universitair Ziekenhuis Brussel.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
BioGenesis
HRG
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01220791
First received: August 27, 2010
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention Phase
In Vitro Fertilization
 Other: In vitro fertilization treatment for infertility
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Progesterone rise above 1.5ng.ml on the day of HCG [ Time Frame: up to 14 days of follicular ovarian stimulation ] [ Designated as safety issue: No ]
    Incidence or high progesterone on the day of HCG triggering


Secondary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: Follow pregnancy until delivery ] [ Designated as safety issue: No ]
    Success rate in IVF cycles


Estimated Enrollment: 130
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 36, more than 10 antral follicles, FSH<12

Exclusion Criteria:

  • endometriosis stage III&IV,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220791

Contacts
Contact: Evangelos Papanikolaou, MD 0030 2310 424284 drvagpapanikolaou@yahoo.gr

Locations
Greece
Biogenesis Recruiting
Thessaloniki, Pylaia, Greece, 55536
Contact: Evangelos Papanikolaou, MD,PhD     0030 2310 989160     drvagpapanikolaou@yahoo.gr    
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
BioGenesis
HRG
Investigators
Study Chair: Basil Tarlatzis, Professor BioGenesis
  More Information

Additional Information:
web page of investigator centre  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Papanikolaou Evangelos, HRG
ClinicalTrials.gov Identifier: NCT01220791     History of Changes
Other Study ID Numbers: Medrol005
Study First Received: August 27, 2010
Last Updated: October 13, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by Universitair Ziekenhuis Brussel:
methylprednisolone
IVF
progesterone
 corticosteroid
late follicular phase
pregnancy rates

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Progesterone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins

ClinicalTrials.gov processed this record on June 13, 2013