Comparison of the efficacy of Metformin and Simvastatin in patients with polycystic ovarian syndrome(PCOS) in Intra Cytoplasmic Sperm Injection(ICSI )cycles.

Comparison of the efficacy of Metformin and Simvastatin in treatment of infertile patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201202138994N1

Enrollment

Registered

2012-12-06

Start date

2012-09-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility. Female infertility associated with anovulation

Interventions

Intervention 1: group 1: metformin 500 mg TDS and oral contraception pill daily for 2 month. Intervention 2: group 2: simvastatin 40 mg daily and oral contraception pill daily for 2 month.

Treatment - Drugs

group 1: metformin 500 mg TDS and oral contraception pill daily for 2 month

group 2: simvastatin 40 mg daily and oral contraception pill daily for 2 month

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria: PCOS, age 20-35, previous history of infertility for at least 1year. Exclusion criteria: tubal infertility, anatomical factors & malformations, male infertility factors, endometriosis, receiving metformin , clomiphene or letrozol, IUI in last 3 months, underline disease such as renal, pulmonary, diabetes mellitus, anti phospholipid syndrome and hypertrigelyceridemia and receiving anti hyperlipidemia drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pregnancy rate. Timepoint: 16 weeks. Method of measurement: Serum B-HCG.	—

Secondary

Measure	Time frame
Body mass index. Timepoint: Before and 2 month after intervention. Method of measurement: BMI index.;TG,Chol(HDL,LDL),FSH,LH,Total Testesteron,GGT with 75 g glucose. Timepoint: Before and 2 month after intervention. Method of measurement: Lab data analize.;Staging of hirsutism. Timepoint: 2 month after intervention. Method of measurement: standard scaling score system.;Ovarian hyperstimulation syndrome. Timepoint: After puncture. Method of measurement: Physical exam and sonography.;Number of oocyte in mitosis 2. Timepoint: After puncture. Method of measurement: Lab data analize.;Number of fetus in grade A. Timepoint: After sperm injection. Method of measurement: Lab data analize.;Cases of ectopic pregnancy. Timepoint: 6 weeks after fetus transfer. Method of measurement: Sonography.;Cases of abortion. Timepoint: 6 weeks after fetus transfer. Method of measurement: physical exam and sonography.	—

Measure

Time frame

Body mass index. Timepoint: Before and 2 month after intervention. Method of measurement: BMI index.;TG,Chol(HDL,LDL),FSH,LH,Total Testesteron,GGT with 75 g glucose. Timepoint: Before and 2 month after intervention. Method of measurement: Lab data analize.;Staging of hirsutism. Timepoint: 2 month after intervention. Method of measurement: standard scaling score system.;Ovarian hyperstimulation syndrome. Timepoint: After puncture. Method of measurement: Physical exam and sonography.;Number of oocyte in mitosis 2. Timepoint: After puncture. Method of measurement: Lab data analize.;Number of fetus in grade A. Timepoint: After sperm injection. Method of measurement: Lab data analize.;Cases of ectopic pregnancy. Timepoint: 6 weeks after fetus transfer. Method of measurement: Sonography.;Cases of abortion. Timepoint: 6 weeks after fetus transfer. Method of measurement: physical exam and sonography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMandana Rouzitalab

Ahwaz Jundishapur University of Medical Sciences

mrouzitalab@yahoo.com+98 61 1222 2114

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026