NCT00575601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 2, 2009

Status Verified

June 1, 2009

First QC Date

December 15, 2007

Last Update Submit

June 30, 2009

Conditions

Polycystic Ovary Syndrome

Keywords

pcosimvastatinivfembryo transfer

Outcome Measures

Primary Outcomes (1)

  • ivf-et outcomes

    14-20 days

Secondary Outcomes (1)

  • Biochemical parameters baseline and 8weeks Biochemical parameters

    baseline and 8weeks

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: SIMVASTATIN

B

PLACEBO COMPARATOR
Drug: SIMVASTATIN

Interventions

SIMVASTATINDRUG

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

AB

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pcos patients
  • Age \<40 years
  • FSH\<10 IU/L

You may not qualify if:

  • Endometriosis grade 3 \&4
  • History of tubal surgery
  • Hydrosalpinx
  • History of mellitis diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeiny Hospital

Tehran, 1419733141, Iran

Location

Related Publications (2)

  • Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.

    PMID: 37462232DERIVED

  • 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.

    PMID: 21527854DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeLong Qt Syndrome 3

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • batool hossein rashidi, MD

    Tehran University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2007

First Posted

December 18, 2007

Study Start

August 1, 2007

Study Completion

April 1, 2009

Last Updated

July 2, 2009

Record last verified: 2009-06

Locations

IR(1)