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Evaluation the effect of silymarin on serum oxidative stress markers and in vitro fertilization outcome in patients with polycystic ovarian syndrome

Protocol summary

Summary
Objectives: Despite the higher number of oocytes obtained from patients with polycystic ovarian syndrome (PCOS) and less need to gonadotropin stimulation, obtained oocytes have less potential for growth, are not able to complete meiosis, and their ability to normal fertilization and embryo formation is reduced. Oxidative stress is one of the effective factors in the incidence of some reproductive diseases such as endometriosis, PCOS, and unexplained infertility. In this study we evaluate the effect of silymarin on serum oxidative stress markers and in vitro fertilization outcome in patients with PCOS. Design: Block randomization, double blind, placebo controlled, single center, trial phase 2, including 40 women with PCOS who are candidate for in vitro fertilization. Participants including major eligibility criteria: Women with PCOS who are candidate for in vitro fertilization Intervention: Silymarin tablet, 70 mg, three times a day, orally. Placebo tablet, three times a day, orally. Main outcome measures: Paraoxonase enzyme activity, Serum concentration of malondialdehyde, Serum CRP level, Number of follicles, Endometrial thickness

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041321743N1
Registration date: 2015-06-16, 1394/03/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Nazila Najdi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
najdin@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of silymarin on serum oxidative stress markers and in vitro fertilization outcome in patients with polycystic ovarian syndrome
Public title
Effect of Milk Thistle on relieving infertility in women with polycystic ovaries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient satisfaction; Age between 20-35 years old; Patients with PCOS. Exclusion criteria: Patients with diabetes mellitus or hypertension; Cigarette smoking; Using antioxidant drugs currently or in the past 3 months; Multifactorial infertility.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Amir Abad, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-03-03, 1393/12/12
Ethics committee reference number
93-12-13

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Paraoxonase enzyme activity
Timepoint
Before using silymarin and after completing usage
Method of measurement
Elisa kit

2

Description
malondialdehyde concentration
Timepoint
Before using silymarin and after completing usage
Method of measurement
Elisa kit

3

Description
C-reactive protein level
Timepoint
Before using silymarin and after completing usage
Method of measurement
Elisa kit

4

Description
number of follicles
Timepoint
After completing silymarin usage
Method of measurement
ultrasonography

5

Description
Endometrial thickness
Timepoint
After completing silymarin usage
Method of measurement
ultrasonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1. Silymarin tablet, 70 mg, three times a day, orally, made in Gol Daroo company, Iran.
Category
Treatment - Drugs

2

Description
Intervention 2. Placebo tablet, three times a day, orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mirza Kouchak Khan hospital
Full name of responsible person
Dr Nazila Najdi
Street address
Ostad Nejatollahi street- Karim Khan boulevard
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Masud Yunesian
Street address
Keshavarz Boulevard, Amir Abad, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Vice Chancellor for Research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Nazila Najdi
Position
Obstetrician and gynecologist
Other areas of specialty/work
Street address
Mirza Kouchak Khan hospital, Ostad Nejatollahi, Karim Khan boulevard
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
najdinnazila@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nazila Najdi
Position
Obstetrician and gynecologist
Other areas of specialty/work
Street address
Mirza Kouchak Khan hospital, Ostad Nejatollahi, Karim Khan boulevard
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
najdinnazila@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nazila Najdi
Position
Obstetrician and gynecologist
Other areas of specialty/work
Street address
Mirza Kouchak Khan hospital, Ostad Nejatollahi, Karim Khan boulevard
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
najdinnazila@yahoo.com
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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