Protocol summary

Summary
1) The study of effect of N-acetyl Cysteine(NAC) & Metformin co-treatment on Biochemical factors of follicular fluid, Oocytes and Embryos quality in patients with PCOs and undergoing ICSI treatment. 2)Through a prospective experimental study designed as a clinical trial, 60 infertile patients diagnosed with PCOS who were referred to IVF Unit of the Reproductive Health Research Center of Gom were enrolled. Overall, considering a 95% confidence interval and 80% power, 60 patients were required as the sample population. 3) Inclusion criteria dictated that the patients needed to fulfill PCOS diagnostic criteria based on the Rotterdam consensus workshop in 2003 . That is, in order to be enrolled, each patient needed to have two out of three chronic oligo or anovulation criteria, clinical or biochemical hyperandrogenism or polycystic ovaries at sonography examination. Presence of infertility factors other than anovulation, pelvic organic pathologies, congenital adrenal hyperplasia, thyroid dysfunction, Cushing’s syndrome, hyperprolactinemia, androgen secreting neoplasia, diabetes mellitus , severe hepatic or kidney diseases, and active peptic ulcer were considered as exclusion criteria. 4) All patients were advised to avoid any change in their physical activity and nutrition and not to undergo any new pharmacotherapy during the study. Patients were asked to report any possible adverse effects. Patients were divided into four groups considering the similarity of compound confounding variables and randomized in order to minimize the effects of confounding factors through a randomized method. 1)Group-M, cases received treatment with Metformin (started with 500 mg three times daily). 2)Group-N, cases received N-acetyl cysteine, 1.8 gm/day (600 mg three times daily). 3)Group-MN, cases received N-acetyl cysteine, 1.8 gm/day (600 mg three times daily)+ Metformin (started with, 500 mg three times daily). 4) 2)Group-P, the control group took placebo (ORS, Poursina, Tehran, Iran, batch no.30).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204159476N1
Registration date: 2012-08-14, 1391/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Ebrahim Cheraghi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3409
Email address
e-cheraghi@phd.araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-07-31, 1391/05/10
Expected recruitment end date
2013-02-28, 1391/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-acetyl Cysteine(NAC) & Metformin co-treatment on Biochemical factors of follicular fluid, Oocytes and Embryos quality in patients with PCOs and undergoing ICSI treatment
Public title
Effect of N-acetyl Cysteine(NAC) & Metformin co-treatment in patients with PCOs and undergoing ICSI treatment
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion critria: age between 25 to 35 years old and PCOS diagnosed according to Rotterdam criteria (2003). Exclusion criteria: presence of infertility factors other than anovulation,male infertility; pelvic organic pathologies; congenital adrenal hyperplasia; thyroid dysfunction; Cushing’s syndrome; hyperprolactinemia; androgen secreting neoplasia; diabetes mellitus; severe hepatic or kidney diseases and active peptic ulcer.
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Royan inistitute Ethics Committee
Street address
Banihashem ave.
City
Tehran
Postal code
Approval date
2012-07-10, 1391/04/20
Ethics committee reference number
EC/91/1041

Health conditions studied

1

Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
N83.2
ICD-10 code description
E28.2

Primary outcomes

1

Description
Biochemical factors of follicular fluid
Timepoint
After 2 month
Method of measurement
Lab. kits

2

Description
Oocyte and embryo quality
Timepoint
After 2 month
Method of measurement
Morphology

3

Description
Biochemical factors of blood serum
Timepoint
After 2 month
Method of measurement
Lab. kits

Secondary outcomes

1

Description
Gastation rate
Timepoint
After 3 month
Method of measurement
Lab. kit

Intervention groups

1

Description
Control group- placebo-ORS- 3 per day for 6 week
Category
Placebo

2

Description
Metformin group- 1500 mg/ day -6 week
Category
Treatment - Drugs

3

Description
NAC group- 1800 mg/day - 6 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
ACECR Qom of INFERTILITY RESEARCH CENTER
Full name of responsible person
Dr. Zahra Ebrahimi, Gynecologist
Street address
Gom, Sharake Isar, Shabnam ave.
City
Gom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mohammad Shariatzadeh
Street address
Arak, Sardasht
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Qom ACECR Infertility Treatment Highly Specialized Center
Full name of responsible person
Dr, Marzie Aavi Soltani
Position
Gynecologist
Other areas of specialty/work
Street address
Gom, Shahrak eisar, Shabnam ave.
City
Gom
Postal code
Phone
+98 25 1270 0155
Fax
Email
m.alavisoltani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ebrahim Cheraghi
Position
PhD candidate
Other areas of specialty/work
Street address
Gom, Shahrak eisar
City
Gom
Postal code
Phone
+98 25 1270 0155
Fax
+98 25 1270 0154
Email
cheraghi20@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ACECR qom
Full name of responsible person
seid reza tabatabaei
Position
MSc
Other areas of specialty/work
Street address
City
qom-shahrake eisar- shabnam ave.
Postal code
Phone
+98 25127001557
Fax
+98 27 00154
Email
taba_1359@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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