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

Protocol summary

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

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202138994N1
Registration date: 2012-12-06, 1391/09/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Mandana Rouzitalab
Name of organization / entity
Ahwaz Jundishapur University of Medicen Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5301
Email address
pourmatroud@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishaour University of Medical Science, Vice Chancellor for Research and Technology
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Metformin and Simvastatin in treatment of infertile patients
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
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahwaz Ethic Committee of Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
61357-15794
Approval date
2011-12-24, 1390/10/03
Ethics committee reference number
u-90218

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
Pregnancy rate
Timepoint
16 weeks
Method of measurement
Serum B-HCG

Secondary outcomes

1

Description
Body mass index
Timepoint
Before and 2 month after intervention
Method of measurement
BMI index

2

Description
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

3

Description
Staging of hirsutism
Timepoint
2 month after intervention
Method of measurement
standard scaling score system

4

Description
Ovarian hyperstimulation syndrome
Timepoint
After puncture
Method of measurement
Physical exam and sonography

5

Description
Number of oocyte in mitosis 2
Timepoint
After puncture
Method of measurement
Lab data analize

6

Description
Number of fetus in grade A
Timepoint
After sperm injection
Method of measurement
Lab data analize

7

Description
Cases of ectopic pregnancy
Timepoint
6 weeks after fetus transfer
Method of measurement
Sonography

8

Description
cases of abortion
Timepoint
6 weeks after fetus transfer
Method of measurement
physical exam and sonography

Intervention groups

1

Description
group 1: metformin 500 mg TDS and oral contraception pill daily for 2 month
Category
Treatment - Drugs

2

Description
group 2: simvastatin 40 mg daily and oral contraception pill daily for 2 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahwaz Reserch & Infertility Center of Emam Khomeiny Hospital
Full name of responsible person
Mandana Rouzitalab
Street address
Emam Khomeiny Hospital, Azadegan avenue
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology
Full name of responsible person
DR Feghhi.Mostafa
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Mandana Rouzitalab
Position
Gynecology and Obsteteric resident
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
mrouzitalab@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Elham Pourmatroud
Position
Obstetrics and Gynecologist, Fellowship of Infertillity and Laparascopy
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
Phone
+98 61 1336 1984
Fax
Email
pourmatroud@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Mandana Rouzitalab
Position
Gynecology and Obstetric resident
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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