Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00575601

Purpose

The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: SIMVASTATIN	Phase III

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients : A Prospective Randomized Double Blind Placebo Controlled Trial

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

ivf-et outcomes [ Time Frame: 14-20 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biochemical parameters baseline and 8weeks Biochemical parameters [ Time Frame: baseline and 8weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
A: Active Comparator	Drug: SIMVASTATIN 20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used
B: Placebo Comparator	Drug: SIMVASTATIN 20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used

Detailed Description:

simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation & decreasing steroidogenesis (production of progestron & testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia& hyperandrogenism .This study will test the hypothesis that simvastatin improves biochemical parameters& IVF-ICSI outcome in Pcos patients.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pcos patients
Age <40 years
FSH<10 IU/L

Exclusion Criteria:

Endometriosis grade 3 &4
History of tubal surjery
Hydrosalpinx
History of mellitus diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575601

Contacts

Contact: batool hossein rashidi, MD	00982166939320	bhrashidi@yahoo.com
Contact: zhila abediasl, MD	+98-9123471504	jabediasl@yahoo.com

Locations

Iran, Islamic Republic of
Imam Khomeiny Hospital	Recruiting
tehran, Iran, Islamic Republic of, 1419733141
Contact: batool hossein rashidi, MD +98-21-66939320 bhrashidi@yahoo.com
Contact: zhila abediasl, MD +98-9123471504 jabediasl@yahoo.com

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair:

batool hossein rashidi, MD

Tehran University of Medical Sciences

More Information

Responsible Party:	Tehran University of Medical Sciences ( Akabr Fotouhi )
Study ID Numbers:	850-39-4796
Study First Received:	December 15, 2007
Last Updated:	December 15, 2007
ClinicalTrials.gov Identifier:	NCT00575601
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

pco
simvastatin
ivf
embryo transfer

Study placed in the following topic categories:

Genital Diseases, Female
Simvastatin
Gonadal Disorders
Polycystic Ovary Syndrome
Endocrine System Diseases

Endocrinopathy
Ovarian Diseases
Cysts
Ovarian Cysts

Additional relevant MeSH terms:

Antimetabolites
Disease
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Adnexal Diseases
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009