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NCT00575601 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

Official title:
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients : A Prospective Randomized Double Blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00575601
Other study ID # 850-39-4796
Secondary ID
Status Completed
Phase Phase 3
First received December 15, 2007
Last updated June 30, 2009
Start date August 2007
Est. completion date April 2009

Study information
Verified date June 2009
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Description:

simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation & decreasing steroidogenesis (production of progesterone & 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Pcos patients

- Age <40 years

- FSH<10 IU/L

Exclusion Criteria:

- Endometriosis grade 3 &4

- History of tubal surgery

- Hydrosalpinx

- History of mellitis diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• SIMVASTATIN
20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used

Locations
Country Name City State
Iran, Islamic Republic of Imam Khomeiny Hospital Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary ivf-et outcomes 14-20 days No
Secondary Biochemical parameters baseline and 8weeks Biochemical parameters baseline and 8weeks No
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