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

June 30, 2009 updated by: Tehran University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: SIMVASTATIN
20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used
Placebo Comparator: B
Drug: SIMVASTATIN
20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ivf-et outcomes
Time Frame: 14-20 days
14-20 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical parameters baseline and 8weeks Biochemical parameters
Time Frame: baseline and 8weeks
baseline and 8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: batool hossein rashidi, MD, Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 15, 2007

First Submitted That Met QC Criteria

December 15, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

July 2, 2009

Last Update Submitted That Met QC Criteria

June 30, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 850-39-4796

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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