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Methylprednisolone Addition in IVF Treatment of Infertile Couples

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220791
First Posted: October 14, 2010
Last Update Posted: October 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
BioGenesis
HRG
Information provided by:
Universitair Ziekenhuis Brussel
  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
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

Resource links provided by NLM:


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 ]
    Incidence or high progesterone on the day of HCG triggering


Secondary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: Follow pregnancy until delivery ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 36 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: Papanikolaou Evangelos, HRG
ClinicalTrials.gov Identifier: NCT01220791     History of Changes
Other Study ID Numbers: Medrol005
First Submitted: August 27, 2010
First Posted: October 14, 2010
Last Update Posted: October 14, 2010
Last Verified: October 2010

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

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