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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: SIMVASTATIN

Study type: Interventional

Funder types: Other

Identifiers

NCT00575601

850-39-4796

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: SIMVASTATIN

B

Placebo Comparator group

Treatment:

Drug: SIMVASTATIN