Protocol summary
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Study aim
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An interventional study that is designed to assess the effect of letrozole and gonadotropin on the success rate of assisted reproductive techniques.
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Design
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Phase 3 clinical trial with a control group, parallel design, using the random allocation rule is performed on 94 patients.
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Settings and conduct
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This randomized study will be performed on 94 patients with IVF indication in Yas Hospital with a convenient sampling method. This is a double-blind study, the patient and analyzer do not know the type of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include women with pelvic endometriosis and primary infertility, in her first IVF cycle, with 18 to 35-year-old and BMI lower than 30 kg/m2, without any uterine diseases and AMH greater than 1 ng/ml. Sperm motility must be at least 20%.
Criteria for not entering: women who underwent letrozole or clomiphene therapy for induction ovulation, Sever endometriosis with DIE, Submucosal myoma, and intramural myoma which were detected in TVS, and withdraw to participation.
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Intervention groups
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On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL.
On the third day of menstruation, the intervention group will receive letrozole 5 mg orally per day for up to 5 days, while in the control group, participants will receive a placebo on the same days as oral pills.
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Main outcome variables
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Cinnal-f and HMG dosage, estradiol level, oocyte number and quality, embryo quality, biochemical pregnancy, and clinical pregnancy
General information
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Reason for update
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Because of the journal request, some parts of the study will be completed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120104008611N12
Registration date:
2021-03-19, 1399/12/29
Registration timing:
prospective
Last update:
2021-06-30, 1400/04/09
Update count:
1
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Registration date
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2021-03-19, 1399/12/29
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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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2021-04-04, 1400/01/15
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Expected recruitment end date
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2021-06-05, 1400/03/15
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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 the effect of combining letrozole and gonadotropin with gonadotropin alone on the IVF / ICSI cycle success rate in women with endometriosis
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Public title
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Assessment the effect of combining letrozole and gonadotropin on the IVF / ICSI cycle success rate
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with 18 to 35 year-old
Body mass index lower than 30 kg/m2
In her first IVF cycle
Without any uterine diseases
Sperm motility of at least 20% in sperm analysis
Anti-mullerin hormone greater than 1 ng/ml
Exclusion criteria:
Women who underwent letrozole or clomiphene therapy for induction ovulation
Sever endometriosis with DIE
Submucosal myoma with any size and intramural myoma greater than 3 cm was detected in transvaginal ultrasound
Withdraw to participation
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Age
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From 18 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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- Participant
- Data analyser
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Sample size
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Target sample size:
94
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation rule: First, 47 letters A and 47 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (letrozole) or B (clomiphene) are determined by a lot.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is performed double-blind, the participants, and the analyzer do not know the type of treatment. The participants, because of placebo usage, do not know the type of their treatment. Also, the analyzer does not know about the treatment group codes in the SPSS datasheet.
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Placebo
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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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2021-01-23, 1399/11/04
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Ethics committee reference number
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IR.TUMS.SINAHOSPITAL.REC.1399.100
Health conditions studied
1
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Description of health condition studied
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Endometriosis
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ICD-10 code
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N80.9
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ICD-10 code description
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Endometriosis, unspecified
Primary outcomes
1
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Description
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The total prescribed dosage of Cinnal-f, and HMG
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Timepoint
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Once, at the trigger day
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Method of measurement
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Will be calculated by gynecologic
2
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Description
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The estradiol level
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Timepoint
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Once, at the trigger day
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Method of measurement
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Blood sample
3
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Description
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The oocyte number, and quality
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Timepoint
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Once, at puncture day
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Method of measurement
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According to the oocyte puberty degree, the oocyte quality will be determined.
4
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Description
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The embryo quality
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Timepoint
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Once, after in vitro fertilization
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Method of measurement
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According to Gardner system
Secondary outcomes
1
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Description
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Biochemical pregnancy
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Timepoint
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Once, 14 days after fetus transfer
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Method of measurement
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Blood sampling
2
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Description
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Clinical pregnancy
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Timepoint
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Once, 6 to 8 weeks after fetus transfer
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Method of measurement
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Pregnancy sac observation in transvaginal ultrasound
Intervention groups
1
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Description
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Intervention group: On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL. On the third day of menstruation, the intervention group will receive letrozole 5 mg orally per day for up to 5 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL. On the third day of menstruation, the control group will receive a placebo orally per day for up to 5 days.
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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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Tehran 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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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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No - There is not 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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All data is potentially shareable after unidentified participants
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When the data will become available and for how long
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After manuscript published
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To whom data/document is available
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No limitations
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Under which criteria data/document could be used
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The data is only available to the project manager, Dr. Pakniat, and any analysis must be done with her opinion.
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From where data/document is obtainable
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Dr. Pakniat
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What processes are involved for a request to access data/document
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Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Pakniat.
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Comments
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