Comparison of clomiphene citrate stair-step protocol with standard protocol on ovulation induction and treatment of infertility in women with polycystic ovarian syndrome
To compare clomiphene citrate stair-step protocol with standard protocol on ovulation induction and treatment of infertility in women with polycystic ovarian syndrome
Design
In this single blinded randomized clinical trial, the researcher goes to infertility clinic daily. Each patient who has inclusion criteria to enroll in the study is considered as a sample. Samples were divided into 2 groups A and B by computer random selection. Patients were randomly divided into intervention and control groups based on randomized block method. Total of 60 patients were enrolled.
Settings and conduct
This clinical trial is carried out at the Infertility Clinic of Besat Hospital in Sanandaj. Patients are unaware of how they are grouped and blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertility due to polycystic ovarian syndrome resistant to treatment and willingness to participate in the study. Exclusion criterion is age over forty years.
Intervention groups
Intervention group 1: From the third day of menstruation, 50 mg clomiphene is administered daily for 5 days on 14th day of menstruation ultrasound is performed. If the size of the follicles was <14 mm, 100 mg clomiphene is administered daily for another 5 days , on the 20th day of menstruation ultrasound is performed. If the size was<14 mm, for another 5 days, 150 mg of clomiphene is administered daily and on the 25th day of menstruation ultrasound is performed.
Intervention group 2: From the third day of menstruation, 50 mg clomiphene is administered daily for 5 days and ultrasound is performed on the 14th day of menstruation. If ovulation is not induced, in the next month protocol repeated with 100 mg , if ovulation not induced, in the next month (the third month) protocol repeated with 150 mg clomiphene.
Main outcome variables
Ovulation induction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190507043502N1
Registration date:2019-05-26, 1398/03/05
Registration timing:registered_while_recruiting
Last update:2019-05-26, 1398/03/05
Update count:1
Registration date
2019-05-26, 1398/03/05
Registrant information
Name
Solmaz Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4655
Email address
solmaz.ghasemi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clomiphene citrate stair-step protocol with standard protocol on ovulation induction and treatment of infertility in women with polycystic ovarian syndrome
Public title
Comparison of clomiphene citrate stair-step protocol with standard protocol on treatment of infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility due to polycystic ovarian syndrome resistant to treatment
willingness to participate in the study
Exclusion criteria:
Age over forty years
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher goes to the clinic daily. Each patient who has inclusion criteria to enroll in the study is considered as a sample. Samples are divided into 2 groups A and B by computer random selection.Patients are randomly divided into two intervention and control groups based on randomized block method, for example: ABAB / AABB / BBAA.
Blinding (investigator's opinion)
Single blinded
Blinding description
Women in the study are unaware of how they are grouped
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
IR.MUK.REC.1397.268
Health conditions studied
1
Description of health condition studied
Ovulation induction
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
The size of follicles
Timepoint
The days 14, 20, 25 of the cycle
Method of measurement
Transvaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: From the third day of menstruation, 50 mg of clomiphene citrate is administered daily to the patients for 5 days and on 14th day of menstruation ultrasound is performed.If the size of the follicles was less than 14 mm, then 100 mg of clomiphene citrate is administered daily for another 5 days and on the 20th day of the menstruation ultrasound is performed. If the size of the follicles was less than 14 mm then for another 5 days, 150 mg of clomiphene citrate is administered daily to the patients and on the 25th day of menstruation ultrasound is performed.
Category
Treatment - Drugs
2
Description
Intervention group: From the third day of menstruation, 50 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation.If ovulation is not induced, in the next month from the third day of menstruation, 100 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation, and if ovulation is not induced, in the next month (the third month) from the third day of menstruation, 150 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Solmaz Ghasemi
Street address
Keshavarz St, Besat Hospital, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66186-34683
Phone
+98 87 3328 5910
Email
solmaz.ghasemi@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Mozh.zarei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Solmaz Ghasemi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
solmaz.ghasemi@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sholeh Shahgheibi
Position
Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz St, Besat Hospital, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3328 5910
Email
shahgheibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Solmaz Ghasemi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
solmaz.ghasemi@muk.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data on the primary outcome is for sharing.
When the data will become available and for how long
One year after the publication the data will be available.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Meta-analysis is allowed on the data of this study.
From where data/document is obtainable
Dr. Solmaz Ghasemi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: solmaz.ghasemi@muk.ac.ir
What processes are involved for a request to access data/document
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.