Protocol summary
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Study aim
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Comparison the effect of letrozole and clomiphene citrate plus letrozole on the pregnancy rate among infertile patients with polycystic ovarian syndrome undergoing induction of ovulation
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Design
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Not blind randomized controlled clinical trial with two parallel groups
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Settings and conduct
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The study place: Infertility Center, Imam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Female aged 35 or lower, mild male factor infertility, Poly cyctic ovarian syndrome
Exclusion criteria: Reluctance to participate in study, body mass index above 27, endocrine disorder including Hypothyroidism, hyperprolactinemia, diminished ovarian reserve
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Intervention groups
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First intervention group: Letrozole (2.5 mg tablet, Iranian hormones Company) is given twice daily from the third to seventh day of the menstrual cycle.
Second intervention group: Clomiphene 2 tablets daily (50 mg tablets, Iran hormones) and Letrozole (2.5 mg tablets, Iran Hormones Company) oral،twice daily fromf the third to seventh day of the menstrual cycle.
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Main outcome variables
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Pregnancy rate
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:
IRCT20160815029374N6
Registration date:
2019-05-24, 1398/03/03
Registration timing:
registered_while_recruiting
Last update:
2023-06-24, 1402/04/03
Update count:
1
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Registration date
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2019-05-24, 1398/03/03
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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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2019-04-04, 1398/01/15
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Expected recruitment end date
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2020-03-19, 1398/12/29
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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 the effects of letrozole with letrozole in combination with clomiphene on ovulation and pregnancy rate in infertile patients with polycystic ovarian syndrom under Ovulation induction
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Public title
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Effects of letrozole in combination with clomiphene on infertility
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Female aged 35 or lower
Mild male factor infertility
Poly cyctic ovarian syndrome
Exclusion criteria:
Reluctance to participate in study
Body mass index above 27
Endocrine disorder including Hypothyroidism, hyperprolactinemia
Diminished ovarian reserve
History of pelvic surgery
History of ovarian hyperstimulation syndrome
Severe male factor infertility
Abnormal hysterosalpingography
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Age
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From 20 years old to 35 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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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
194
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the first phase of sampling, after applying the criteria for entry and exclude, samples are selected in an accessible manner. Individuals with the criteria for entering, informed consent are obtained. Then, in the second phase, the samples will be assigned to two groups by blocking method. Create blocks and generate random numbers with Random allocation soft ware. The thirty-two blocks of size six will be produced and arranged by the project manager.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The individuals implementing the intervention and evaluating the outcome will not be aware of the allocation of participants.
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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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2019-03-06, 1397/12/15
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Ethics committee reference number
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IR.MAZUMS.IMAMHOSPITAL.REC.1398.001
Health conditions studied
1
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Description of health condition studied
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Disease of genitourinary tract
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ICD-10 code
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Female inf
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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Three weeks after positive B-HCG
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Method of measurement
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ultrasonography
2
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Description
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Ovulation rate
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Timepoint
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Forty-eight hours after HCG injection
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Method of measurement
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ultrasonography
Intervention groups
1
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Description
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Intervention group 1: Letrozole (2.5 mg tablet, Iranian hormones Company) is given twice daily from the third to seventh day of the menstrual cycle.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Clomiphene 2 tablets daily (50 mg tablets, Iran hormones) and Letrozole (2.5 mg tablets, Iran Hormones Company) oral،twice daily from the third to seventh day of the menstrual cycle.
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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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Mazandaran 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available