1. Home
  2. Approved trials
  3. » فارسی

Comparison of the adjuvant effect of N-acetylcysteine and metformin in induction of ovulation in infertile women with polycystic ovary syndrome treated with clomiphene citrate

Protocol summary

Study aim
Comparison of adjuvant efficacy of two treatment regimens including metformin and n-acetylcysteine with clomiphene citrate in induction of ovulation and fertility improvement in infertile women with polycystic ovary syndrome
Design
Clinical trial with control group, with parallel groups, single blinded, randomized, phase 3 on 50 patients. In this study, we will use the block randomization method.
Settings and conduct
This randomized clinical trial study will be performed on infertile women with polycystic ovary syndrome. Patients are randomly divided into two groups by block randomization method, one group receiving N-acetylcysteine and the other group receiving metformin. Patients will be unaware of how randomization occurs. In both groups and on days 12 to 16 of the cycle, transvaginal ultrasound will be performed.
Participants/Inclusion and exclusion criteria
Infertile female will enroll the study who aged between 20 and 35 years old with polycystic ovary syndrome and normal hysterosalpingography who are candidate for ovulation induction by normal sperm analysis Exclusion criteria are: Endocrine diseases such as abnormal thyroid and prolactin, using metformin and clomiphene in the previous cycle to induce ovulation, patients who are clomiphene-resistance, allergic reaction with metformin or N-acetylcysteine, simple ovarian cyst, liver disease
Intervention groups
In the first intervention group, n-acetylcysteine 1200 mg (Produced by Shimi Daru Company) will be ordered daily in two divided doses and in the second intervention group, metformin 1500 mg daily (Produced by Shimi Daru Company) in three divided doses from the first day of the cycle for 4 weeks.
Main outcome variables
number of follicles, endometrial thickness, size of follicles, frequency of intrauterine sac

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210310050658N1
Registration date: 2022-02-11, 1400/11/22
Registration timing: prospective

Last update: 2022-02-11, 1400/11/22
Update count: 0
Registration date
2022-02-11, 1400/11/22
Registrant information
Name
Mozhgan Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 7436
Email address
mozhganahmadi13691990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the adjuvant effect of N-acetylcysteine and metformin in induction of ovulation in infertile women with polycystic ovary syndrome treated with clomiphene citrate
Public title
N-acetylcysteine and metformin in induction of ovulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 20-35 years infertile with polycystic ovary syndrome candidates for ovulation induction spouse with normal sperm analysis with normal hysterosalpingography without tubular pathology
Exclusion criteria:
Endocrine and endocrinological diseases such as thyroid disorders and abnormal prolactin Patients who used metformin and clomiphene more frequently in the previous cycle to induce ovulation Clomiphene resistant patients Pituitary or hypothalamic disorders characterized by low gonadotropin levels Drug allergy to metformin or N Acetyl Cystein Simple ovarian cyst Liver disease
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. The size of all blocks is equal and the block size will be 6 (including 3 participants in the intervention group and 3 participants in the control group) in this two-group experiment. Random allocation software is also used to generate a random sequence of blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the drug prescribing protocol.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1435689752
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.ZUMS.REC.1399.454

Health conditions studied

1

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

Primary outcomes

1

Description
Number of follicles
Timepoint
Four weeks after the intervention
Method of measurement
Transvaginal ultrasound

2

Description
Endometrial thickness
Timepoint
Four weeks after the intervention
Method of measurement
Transvaginal ultrasound

3

Description
Size of follicles
Timepoint
Four weeks after the intervention
Method of measurement
Transvaginal ultrasound

4

Description
frequency of intrauterine sac
Timepoint
Four weeks after the intervention
Method of measurement
Transvaginal ultrasound

Secondary outcomes

1

Description
positive human chorionic gonadotropin (HCG)
Timepoint
Four weeks after the intervention
Method of measurement
ELIZA test

Intervention groups

1

Description
Intervention group: N-acetylcystein administration (produced by Shimi Daru Company)1200 mg daily in two divided doses from the first day of the cycle for 4 weeks
Category
Treatment - Drugs

2

Description
Intervention group: Metformin (produced by Shimi Daru Company) 1500 mg daily in three divided doses from the first day of the cycle for 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Clinic of Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Mozhgan Ahmadi
Street address
Infertility Clinic, Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Mozhganahmadi13691990@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical Sciences Campus, Dr. Yousef Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۸۴
Phone
+98 24 3301 8100
Email
riasat@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mozhgan Ahmadi
Position
Non-faculty specialist physician
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678552
Phone
+98 21 8806 4148
Email
mozhganahmadi13691190@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mozhgan Ahmadi
Position
Non-faculty specialist physician
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1422356522
Phone
+98 21 8806 4148
Email
mozhganahmadi13691990@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mozhgan Ahmadi
Position
Non-faculty specialist physician
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1422432425
Phone
+98 21 8806 4148
Email
mozhganahmadi13691190@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data including the main and secondary outcomes can be shared.
When the data will become available and for how long
Access period starts from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals.
From where data/document is obtainable
Contact the research expert of the Infertility Clinic of Zanjan University to receive the required documents or data.
What processes are involved for a request to access data/document
To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her.
Comments
Loading...