Methylprednisolone Addition in IVF Treatment of Infertile Couples

NCT ID: NCT01220791

Last Updated: 2010-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

In vitro fertilization treatment for infertility

Intervention Type OTHER

IVF treatment

No medrol group

Patients will receive only Antagonist protocol for IVF as usual

Group Type PLACEBO_COMPARATOR

In vitro fertilization treatment for infertility

Intervention Type OTHER

IVF treatment

Interventions

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In vitro fertilization treatment for infertility

IVF treatment

Intervention Type OTHER

Other Intervention Names

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pregnancy MEDROL progesterone

Eligibility Criteria

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Inclusion Criteria

* less than 36, more than 10 antral follicles, FSH\<12

Exclusion Criteria

* endometriosis stage III\&IV,
Minimum Eligible Age

21 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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BioGenesis

INDUSTRY

Sponsor Role collaborator

HRG

UNKNOWN

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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HRG

Principal Investigators

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Basil Tarlatzis, Professor

Role: STUDY_CHAIR

BioGenesis

Locations

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Biogenesis

Thessaloniki, Pylaia, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Evangelos Papanikolaou, MD

Role: CONTACT

0030 2310 424284

Facility Contacts

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Evangelos Papanikolaou, MD,PhD

Role: primary

0030 2310 989160

References

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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.

Reference Type BACKGROUND
PMID: 8897119 (View on PubMed)

Related Links

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http://www.hrg.gr

web page of investigator centre

Other Identifiers

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Medrol005

Identifier Type: -

Identifier Source: org_study_id