Protocol summary
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Study aim
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Comparison of the effect of two methods of cabergoline administration to prevent Ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome.
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Design
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This study is designed as a randomized, single-blind clinical trial with parallel groups with a sample size of 100 individuals per group
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Settings and conduct
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This clinical trial will be conducted in the infertility department of Arash Hospital. 200 infertile women with PCO who undergo IVF and are at high risk of OHSS will be included in the study. They are randomly assigned to two groups one and two. In the IVF process, in group one,tablets cabergoline(0.5 mg) are prescribed orally and daily for 15 days at the same time as the GNRH antagonist is started, and in group two, in the IVF process, tablets cabergoline (0.5 mg) are prescribed at the same time as the trigger (GNRH agonist) is started. It is prescribed orally for 8 days.
IVF process will be done for both groups. From three days after ovarian puncture, clinical and laboratory symptoms and ultrasound examination are performed to check OHSS. The outcome examiner will be unaware of the type of intervention. But the patient will be aware of the type of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age of 18-45 patients, with polycystic ovary syndrome, high AMH and AFC
Exclusion criteria: sensitivity to cabergoline, not taking the drug completely, discontinuation of the drug due to side effects or drug sensitivity
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Intervention groups
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Intervention group 1: Simultaneously with the start of GNRH antagonist, half a milligram of cabergoline is prescribed for 15 days
Intervention group 2: In this group, at the same time as the trigger (GNRH agonist) begins, half a milligram of cabergoline is prescribed for 8 days.
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Main outcome variables
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Ovarian hyperstimulation syndrome
General information
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Reason for update
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The inclusion criteria for AFC and AMH were not precisely defined. High AFC means the number of antral follicles above 20, and AMH means the serum level of antimullerin hormone above 3ng/ml.
Also, the secondary outcomes of the study were not registered, which was added to the list of secondary outcomes.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090526001952N16
Registration date:
2023-05-30, 1402/03/09
Registration timing:
registered_while_recruiting
Last update:
2023-10-07, 1402/07/15
Update count:
1
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Registration date
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2023-05-30, 1402/03/09
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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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2023-03-01, 1401/12/10
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Expected recruitment end date
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2023-11-21, 1402/08/30
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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 the effect of two cabergoline administration methods to prevent ovarian hyperstimulation syndrome (OHSS) in patients with polycystic ovary syndrome (PCO) under IVF
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Public title
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Comparison of the effect of two methods of cabergoline administration to prevent ovarian hyperstimulation syndrome in women with polycystic ovary syndrome
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range of 18 to 45 years old
Patients with polycystic ovary syndrome
high level of anti-müllerian hormone (AMH) level (> 3 ng/ml) and/or high antral follicle count (AFC)>20
Exclusion criteria:
Allergy to cabergoline
Not taking the drug completely
Stopping the drug due to side effects or drug sensitivity
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Age
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From 18 years old to 45 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
- Data analyser
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Sample size
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Target sample size:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Our sample size is 200 people, with 100 people in each group. The randomization method used in this study will be the block randomization method developed by the statistics expert by using the STATA software in a randomization list format. Then, according to the randomization list, the type of intervention for each individual will be written on paper, and the paper will be put in a sealed envelope. Envelopes will be numbered according to the randomization list. The physician will examine the patient's eligibility, and if the patient is eligible, she will tell the hospital research assistant. The research assistant will then provide the sealed envelope to the physician, and the physician will begin the intervention according to the contents of the envelope.or.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Because of the kind of intervention, The patient will be aware of the treatment. Outcomes assessor will not be informed about the kind of treatment A statistician who is unaware of the type of interventions in each group will analyze the data
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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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2023-02-27, 1401/12/08
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1401.806
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Ovarian hyperstimulation syndrome
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Timepoint
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Three days after pancture
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Method of measurement
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Ultrasound and clinical findings
Secondary outcomes
1
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Description
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Checking the hematocrit level
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Timepoint
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Three days after ovum-pick up day
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Method of measurement
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5 cc of blood is drawn in fasting state and the hematocrit level will be measured in Arash Hospital's laboratory with the (Counter SYSMEX KS-500i) device, and the device is calibrated every morning by the responsible expert.
2
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Description
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Abdominal circumference
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Timepoint
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Three days after ovum-pick up day
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Method of measurement
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The abdominal circumference is measured at the midpoint of the line between the rib or costal margin and the iliac crest in the midaxillary line by using tape measure.
3
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Description
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Patient’s satisfaction
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Timepoint
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2 weeks after ovum-pick up day
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Method of measurement
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Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.
4
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Description
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Serum creatinine level
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Timepoint
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Three days after ovum-pick up day
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Method of measurement
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5 cc of blood is drawn in the fasting state and and the level of serum creatinine will be measured in the laboratory of Arash hospital using the Hitachi 717 device and the Jaffe’s method.
5
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Description
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Serum sodium and potassium levels
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Timepoint
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Three days after ovum-pick up day
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Method of measurement
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5 cc of blood is drawn in fasting state and the serum levels of sodium and potassium will be measured in the laboratory of Arash Hospital using the Automatic Electrolyte analyzer of AUDICOM company and the ion selective electrode (ISE) method.
Intervention groups
1
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Description
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Intervention group1: At the same time as starting the GNRH antagonist, cabergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 15 days.
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Category
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Treatment - Drugs
2
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Description
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Intervention group2:In this group, at the same time as the trigger (GNRH agonist) begins, abergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 8 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be 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