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NCT01220791 Clinical Trial

Methylprednisolone Addition in IVF Treatment of Infertile Couples

In Vitro Fertilization Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01220791
Other study ID # Medrol005
Secondary ID
Status Recruiting
Phase Phase 4
First received August 27, 2010
Last updated October 13, 2010
Start date January 2009
Est. completion date December 2011

Study information
Verified date October 2010
Source Universitair Ziekenhuis Brussel
Contact Evangelos Papanikolaou, MD
Phone 0030 2310 424284
Email drvagpapanikolaou@yahoo.gr
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 130
Est. completion date December 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 36 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- endometriosis stage III&IV,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• In vitro fertilization treatment for infertility
IVF treatment

Locations
Country Name City State
Greece Biogenesis Thessaloniki Pylaia

Sponsors (3)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel BioGenesis, HRG

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Progesterone rise above 1.5ng.ml on the day of HCG Incidence or high progesterone on the day of HCG triggering up to 14 days of follicular ovarian stimulation No
Secondary Clinical pregnancy rate Success rate in IVF cycles Follow pregnancy until delivery No
See also
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Recruiting NCT04122729 - N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
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Terminated NCT00866008 - A Study of the Effects of a Novel Ovarian Stimulation Regimen on Embryo Aneuploidy Rates in In Vitro Fertilization (IVF) Phase 4
Recruiting NCT04082650 - Vitamin D and Pregnancy Outcome in PCOS Patients N/A
Recruiting NCT03758833 - eSET or eDET Associated to PGT in IVF N/A
Not yet recruiting NCT04407871 - Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct) N/A
Recruiting NCT03345030 - The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome N/A
Not yet recruiting NCT06367985 - CAPA-IVM Culture With Low Oxygen Tension N/A
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A
Terminated NCT01614067 - Delayed Start to Ovarian Stimulation Phase 4
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