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

Phase 3

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: SIMVASTATIN

• Registration Number: NCT00575601
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-15
• Study First Submitted QC: 2007-12-15
• Study First Posted: 2007-12-18
• Study Completion: 2009-04
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-30
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	SIMVASTATIN	-
B	SIMVASTATIN	-

Primary Outcome Measures

Name	Time	Method
ivf-et outcomes	14-20 days

Secondary Outcome Measures

Name	Time	Method
Biochemical parameters baseline and 8weeks Biochemical parameters	baseline and 8weeks

Trial Locations

Locations (1)

Imam Khomeiny Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of