Protocol summary
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Study aim
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To compare clomiphene citrate stair-step protocol with standard protocol on ovulation induction and treatment of infertility in women with polycystic ovarian syndrome
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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 <12 mm, 100 mg clomiphene is administered daily for another 5 days , on the 20th day of menstruation ultrasound is performed. If the size was<12 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.
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Main outcome variables
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Ovulation induction
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190507043502N1
Registration date:
2019-05-26, 1398/03/05
Registration timing:
registered_while_recruiting
Last update:
2020-01-28, 1398/11/08
Update count:
1
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Registration date
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2019-05-26, 1398/03/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-22, 1398/03/01
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Expected recruitment end date
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2019-10-22, 1398/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of clomiphene citrate stair-step protocol with standard protocol on ovulation induction and treatment of infertility in women with polycystic ovarian syndrome
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Public title
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Comparison of clomiphene citrate stair-step protocol with standard protocol on treatment of infertility
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Infertility due to polycystic ovarian syndrome resistant to treatment
willingness to participate in the study
Exclusion criteria:
Age over forty years
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Women in the study are unaware of how they are grouped
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-25, 1397/10/04
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Ethics committee reference number
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IR.MUK.REC.1397.268
Health conditions studied
1
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Description of health condition studied
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Ovulation induction
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ICD-10 code
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N97.0
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ICD-10 code description
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Female infertility associated with anovulation
Primary outcomes
1
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Description
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The size of follicles
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Timepoint
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The days 14, 20, 25 of the cycle
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Method of measurement
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Transvaginal ultrasonography
Intervention groups
1
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Description
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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 12 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 12 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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sanandaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of the data on the primary outcome is for sharing.
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When the data will become available and for how long
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One year after the publication the data will be available.
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Meta-analysis is allowed on the data of this study.
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From where data/document is obtainable
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Dr. Solmaz Ghasemi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: solmaz.ghasemi@muk.ac.ir
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What processes are involved for a request to access data/document
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After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.
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Comments
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