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

NCT ID: NCT00575601

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

SIMVASTATIN

Intervention Type DRUG

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

B

Group Type PLACEBO_COMPARATOR

SIMVASTATIN

Intervention Type DRUG

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

Interventions

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SIMVASTATIN

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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batool hossein rashidi, MD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Locations

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Imam Khomeiny Hospital

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 37462232 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21527854 (View on PubMed)

Other Identifiers

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850-39-4796

Identifier Type: -

Identifier Source: org_study_id

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