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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00575601

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: SIMVASTATIN	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

ivf-et outcomes [14-20 days]

Secondary Outcome Measures

Biochemical parameters baseline and 8weeks Biochemical parameters [baseline and 8weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imam Khomeiny Hospital	Tehran		Iran, Islamic Republic of	1419733141

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00575601

Other Study ID Numbers:

850-39-4796

First Posted:

Dec 18, 2007

Last Update Posted:

Jul 2, 2009

Last Verified:

Jun 1, 2009

Keywords provided by , ,

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Simvastatin

Study Results

No Results Posted as of Jul 2, 2009