Protocol summary
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Study aim
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Determination of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome in treatment with ovulation-stimulating drugs
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Design
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Randomised, superiority, parallel group trial. Randomisation was centralised and computerised with excel software rand function.
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Settings and conduct
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The study was performed at the Infertility Center of Isfahan University of Medical Sciences. Diagnosis of polycystic ovaries was made according to Rotterdam criteria, including two of the three items of hyperandrogenism disorder, chronic anovulation and polycystic ovary appearance in morphological examination with transvaginal ultrasound (TVS).
Lab tests including FSH, LH, progesterone, estradiol (E2) and Anti-Müllerian hormone were performed.
Ultrasound assessment was performed to measure the number of ovarian follicles with a size of 2 -10 mm and evaluation the thickness of the uterine endometrium on 3th day of the menstrual cycle.
Then the GNRH Antagonist treatment protocol was performed for patients in both case and control groups.
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Participants/Inclusion and exclusion criteria
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Patients with polycystic ovaries and fertility disorders
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Intervention groups
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Intervention group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day with Letrozole 5 mg/daily.
Control group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day.
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Main outcome variables
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Reduced occurrence of ovarian hyperstimulation syndrome
General information
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Reason for update
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Expected sample size increase
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180313039085N1
Registration date:
2021-04-10, 1400/01/21
Registration timing:
retrospective
Last update:
2021-11-25, 1400/09/04
Update count:
1
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Registration date
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2021-04-10, 1400/01/21
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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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2020-03-20, 1399/01/01
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Expected recruitment end date
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2021-03-21, 1400/01/01
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Actual recruitment start date
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2020-03-20, 1399/01/01
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Actual recruitment end date
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2021-03-21, 1400/01/01
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Trial completion date
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2021-03-21, 1400/01/01
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Scientific title
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Evaluation of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome in patients at risk of treatment with ovulation-stimulating drugs
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Public title
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Evaluation of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidate for treatment with ovarian superovulation drugs
history of one year of infertility at least
Body mass index less than 25 kg/m2
Antimullerian hormone levels higher than 5 ng/ml
Exclusion criteria:
History of any hormone therapy during the previous three months
History of allergy to letrozole and other aromatase inhibitors
History of heart disease
History of kidney disease
History of liver disease
History of endocrine diseases
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Age
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From 20 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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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sampling was non-probabilistic and easy. Then patients were randomly divided into four groups: 40 in the letrozole treatment group and 40 in the letrozole-free group. In this randomization method, quadruple therapy blocks (with 10 probabilities) were randomly moved back and forth, and a balanced random list of two treatment groups was obtained with the aim that if the total number of samples was not complete, both groups would be equal.
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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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2021-02-09, 1399/11/21
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Ethics committee reference number
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IR.MUI.MED.REC.1399.1031
Health conditions studied
1
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Description of health condition studied
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Hyperstimulation of ovaries
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ICD-10 code
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N98.1
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ICD-10 code description
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Hyperstimulation of ovaries
Primary outcomes
1
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Description
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Hyperstimulation of ovaries
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Timepoint
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Two weeks after starting treatment
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Method of measurement
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Mild, Moderate, Severe
Intervention groups
1
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Description
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Intervention group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day with Letrozole 5 mg/daily.
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Category
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Treatment - Drugs
2
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Description
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Control group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day.
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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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Esfahan 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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Confidentiality of patient data
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Study Protocol
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Undecided - It is not yet known if there will be 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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No - There is not 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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Undecided - It is not yet known if there will be a plan to make this available