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Comparison of the efficacy of Metformin and Simvastatin in treatment of infertile patients
Acronym :
IRCT registration number : Irct registration number : IRCT201202138994N1
Date registered : December 6, 2012
Registration timing : Retrospective registration
   
Recruitment status : Recruitment complete
Expected recruitment start date : 2012-09-22
Expected recruitment end date : 2012-11-21
   
Scientific title : Comparison of the efficacy of Metformin and Simvastatin in treatment of infertile patients
Summary :

1-objective: comparison of metformin & simvastatin in management of infertility 2-Design: randomized Clinical trial, not blinded . 3-setting & conduct: 40, 20-35 years old women with PCOS and infertility history after matching BMI and normalizing TSH and Prolactin are divided into 2 groups of 20.In Third day of menstruation periods, Hirsutism staging and lab data such as Total Testosterone, LH, FSH, TG , Cholestrole (LDL, HDL), GTT with 75g Glucose were done. Previous tests have been repeated again in the third day of period and hirsutism staging was done, then ICSI protocol was started. the largest diameter of follicles were examined by trans vaginal ultrasound. the numbers of oocyte mitosis 2 after puncture, the numbers of embryo grade A after sperm injection and the risk of OHSS were evaluated. 2 weeks after embryo transfer, Pregnancy was proved by β-HCG and ultrasound was done after 6 weeks to determine Abortion and ectopic pregnancy and then during 12 weeks of pregnancy patients were followed. participants:Inclusion criteria: PCOS, 20-35 years, history of infertility for at least one year. Exclusion criteria: Tubal, anatomical factors, malformations, male factors, endometriosis. Receiving Metformin, Clomiphene or letrozole within 3 months, IUI within 3 months ago, the underlying disease, such as kidney problems, lung disease, diabetes melitus, antiphospholipid syndrome, history of hyperlipidemia and relating drugs. 5-intervention: One group treated with OCP daily+ Metformin TDS for 8 weeks and another group treated with OCP + Simvastatin daily for 8 weeks. 6-main outcome measures variables: rate of pregnancy

   
Public title : Comparison of the efficacy of Metformin and Simvastatin in patients with polycystic ovarian syndrome(PCOS) in Intra Cytoplasmic Sperm Injection(ICSI )cycles.
Purpose : Treatment
Inclusion/exclusion 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
Maximum age : Year: 150         
Gender : female
   
Health condition table is empty1 : Infertility
Condition studied : N97.0
Condition ICD-10 code : Female infertility associated with anovulation
   
Intervention/Control1 group 1: metformin 500 mg TDS and oral contraception pill daily for 2 month
Intervention category Treatment: drugs
Intervention/Control2 group 2: simvastatin 40 mg daily and oral contraception pill daily for 2 month
Intervention category Treatment: drugs
   
Primary outcome measure1: Pregnancy rate
Primary outcome time point 16 weeks
Primary outcome method of measurement Serum B-HCG
   
Secondary outcome measure 1 : Body mass index
Secondary outcome time point Before and 2 month after intervention
Secondary outcome method of measurement BMI index
Secondary outcome measure 2 : cases of abortion
Secondary outcome time point 6 weeks after fetus transfer
Secondary outcome method of measurement physical exam and sonography
Secondary outcome measure 3 : Cases of ectopic pregnancy
Secondary outcome time point 6 weeks after fetus transfer
Secondary outcome method of measurement Sonography
Secondary outcome measure 4 : Staging of hirsutism
Secondary outcome time point 2 month after intervention
Secondary outcome method of measurement standard scaling score system
Secondary outcome measure 5 : Ovarian hyperstimulation syndrome
Secondary outcome time point After puncture
Secondary outcome method of measurement Physical exam and sonography
Secondary outcome measure 6 : Number of oocyte in mitosis 2
Secondary outcome time point After puncture
Secondary outcome method of measurement Lab data analize
Secondary outcome measure 7 : Number of fetus in grade A
Secondary outcome time point After sperm injection
Secondary outcome method of measurement Lab data analize
Secondary outcome measure 8 : TG,Chol(HDL,LDL),FSH,LH,Total Testesteron,GGT with 75 g glucose
Secondary outcome time point Before and 2 month after intervention
Secondary outcome method of measurement Lab data analize
Trial phase : 2-3
Target sample size : 40
Randomization : randomized
Blinding : Not blinded
Placebo : not used
Assignment : Parallel
Other design features :
   
Centre name 1 Ahwaz Reserch & Infertility Center of Emam Khomeiny Hospital
Contact person's name Mandana Rouzitalab
Country Iran, Islamic Republic Of
Contact details : Emam Khomeiny Hospital, Azadegan avenue
Ahwaz
Khozestan
6193673166
00986112222114
00
00
pourmatroud@ajums.ac.ir
   
Ethics committee name 1 Ahwaz Ethic Committee of Jundishapur University of Medical Sciences
Date approved 2011-12-24
Reference number u-90218
Contact details : Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
Ahwaz
Khozestan
Iran, Islamic Republic Of
61357-15794
   
Sponsor 1 Ahwaz Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology
Contact person's name DR Feghhi.Mostafa
Contact details : Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
Ahwaz
Khozestan
Iran, Islamic Republic Of
61357-15794
00986113333477
00

Feghhim671@live.com
   
Person responsible for general inquiries
Mandana Rouzitalab
Affiliated Organization name Ahwaz Jundishapur University of Medical Sciences
Position/degree Gynecology and Obsteteric resident
Contact details : Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
Ahwaz
Khozestan
Iran, Islamic Republic Of
00986112222114
00
mrouzitalab@yahoo.com
   
Person responsible for scientific inquiries
Dr Elham Pourmatroud
Affiliated Organization name Ahwaz Jundishapur University of Medical Sciences
Position / degree Obstetrics and Gynecologist, Fellowship of Infertillity and Laparascopy
Contact details : Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
Ahwaz
Khozestan
Iran, Islamic Republic Of
00986113361984
00
pourmatroud@ajums.ac.ir
   
Person responsible for updating data
Mandana Rouzitalab
Affiliated Organization name Ahwaz Jundishapur University of Medical Sciences
Position / degree Gynecology and Obstetric resident
Contact details : Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
Ahwaz
Khozestan
Iran, Islamic Republic Of
   
Registered by : Mandana  Rouzitalab
Ahwaz Jundishapur University of Medicen Sciences
Ahwaz Jundishapur University of Medicen Sciences, Esfand avenue, Golestan bulvard
Ahwaz
Khozestan
Iran, Islamic Republic Of
Phone: 00987116265301
Fax: 00987116275264
pourmatroud@ajums.ac.ir