Methylprednisolone Addition in IVF Treatment of Infertile Couples

October 13, 2010 updated by: Universitair Ziekenhuis Brussel

Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Pylaia
      • Thessaloniki, Pylaia, Greece, 55536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis stage III&IV,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 14 days of follicular ovarian stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: Follow pregnancy until delivery
Success rate in IVF cycles
Follow pregnancy until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

BioGenesis
HRG

Investigators

  • Study Chair: Basil Tarlatzis, Professor, Biogenesis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (Estimate)

October 14, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2010

Last Update Submitted That Met QC Criteria

October 13, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medrol005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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