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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
SIMVASTATIN
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polycystic Ovary Syndrome focused on measuring pco, simvastatin, ivf, embryo transfer

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Imam Khomeiny Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

ivf-et outcomes

Secondary Outcome Measures

Biochemical parameters baseline and 8weeks Biochemical parameters

Full Information

First Posted
December 15, 2007
Last Updated
June 30, 2009
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00575601
Brief Title
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients
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 Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
pco, simvastatin, ivf, embryo transfer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SIMVASTATIN
Intervention Description
20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used
Primary Outcome Measure Information:
Title
ivf-et outcomes
Time Frame
14-20 days
Secondary Outcome Measure Information:
Title
Biochemical parameters baseline and 8weeks Biochemical parameters
Time Frame
baseline and 8weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
batool hossein rashidi, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Imam Khomeiny Hospital
City
Tehran
ZIP/Postal Code
1419733141
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21527854
Citation
Rashidi B, Abediasl J, Tehraninejad E, Rahmanpour H, Sills ES. Simvastatin effects on androgens, inflammatory mediators, and endogenous pituitary gonadotropins among patients with PCOS undergoing IVF: results from a prospective, randomized, placebo-controlled clinical trial. J Investig Med. 2011 Aug;59(6):912-6. doi: 10.2310/JIM.0b013e31821bfd9c.
Results Reference
derived

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

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