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Completed

NCT Number: NCT00575601

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

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Long Qt Syndrome 3 Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Imam Khomeiny Hospital

Tehran, 1419733141, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

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

Primary outcomes

  1. ivf-et outcomes

    Time frame: 14-20 days

Secondary outcomes

  1. Biochemical parameters baseline and 8weeks Biochemical parameters

    Time frame: baseline and 8weeks

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2009
First posted
Dec 18, 2007
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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