Protocol summary
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Study aim
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Effect of adding letrozole to gonadotropin on pregnancy outcomes
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Design
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Clinical trials, sample size 100 patients, phase 3 of the clinical trial, with the control group, with parallel groups, without blindness, randomized with an enveloped packet.
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Settings and conduct
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This Randomized clinical trial without blindness is conducted for evaluating the effect of intrauterine injection of PRP in Asherman patients referred to Shahid Sadoughi Hospital or Research and Clinical Center for Infertility, Yazd, Iran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Infertile patients which are the candidate for ART.
Exclusion criteria: History of endocrine disorders, Intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions), Azoospermia of partner Severe endometriosis
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Intervention groups
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Intervention group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, all patients in this group will receive 5 mg letrozole orally science the second day of the cycle When dominant follicle reached to 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.
Control group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, When the dominant follicle reached 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.
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Main outcome variables
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Chemical pregnancy rate, clinical pregnancy rate
General information
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Reason for update
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Updating the trial according to the last changes in methods and adding results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N19
Registration date:
2018-09-18, 1397/06/27
Registration timing:
registered_while_recruiting
Last update:
2021-03-31, 1400/01/11
Update count:
2
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Registration date
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2018-09-18, 1397/06/27
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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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2018-08-01, 1397/05/10
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Expected recruitment end date
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2019-02-01, 1397/11/12
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Actual recruitment start date
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2018-08-01, 1397/05/10
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Actual recruitment end date
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2018-12-30, 1397/10/09
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Trial completion date
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2019-02-15, 1397/11/26
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Scientific title
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The effect of adding letrozole to gonadotropin on pregnancy outcomes in patients who are the candidate for assisted reproductive techniques
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Public title
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Letrozole in assisted reproductive techniques protocol
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients referred to the Infertility Center, which is undergoing ovulation induction for assisted reproductive techniques.
normal ovarian reserve
Exclusion criteria:
History of endocrine disorders
Intrauterine abnormality (uterine polyp & sub mucosal fibroma & intrauterine adhesions)
Azoospermia of partner
Severe endometriosis
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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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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using computer-generated random numbers in wrapped,
unlabeled envelope each holding a unique number.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2018-06-20, 1397/03/30
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Ethics committee reference number
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Ir.SSU.RSI.REC.1397.009
Health conditions studied
1
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Description of health condition studied
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female Infertility
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ICD-10 code
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N97.9
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ICD-10 code description
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Female infertility, unspecified
Primary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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15 days after embryo transfer
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Method of measurement
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Blood laboratory kit
2
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Description
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Clinical pregnancy
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Timepoint
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3 weeks after positive beta-h Cg
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Method of measurement
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Observation of fetal heart activity by transvaginal ultrasonography
Intervention groups
1
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Description
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Control group: Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously, all patients in this group will receive 5 mg letrozole (Iran hormone-Iran)) orally science send day of cycle, When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.
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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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Yazd 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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Due to the privacy of patients
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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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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use in the retrospective study
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From where data/document is obtainable
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use in the retrospective study
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What processes are involved for a request to access data/document
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Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2021-03-07, 1399/12/17
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2020-04-30, 1399/02/11
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Abstract of published paper
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Abstract
Background
Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth.
Objective
This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders.
Materials and Methods
In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins.
Results
Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
Conclusion
Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.