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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General information
2023-06-20, 1402/03/30
2023-03-01, 1401/12/10
2023-0603-2001 00:00:00
2023-08-11, 1402/05/20
2023-11-21, 1402/08/30
2023-0811-1121 00:00:00
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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.
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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در معیارهای ورود AFC و AMH بالا درست تعریف نشده بود. منظور از AFC بالا تعداد فولیوکلهای آنترال بالای 20 عدد و منظور از AMH سطح سرمی آنتی مولرین هورمون بالای 3ng/ml می باشد.
همچنین پیامد ثانویه طرح نیز ثبت نشده بود که به لیست پیامدهای ثانویه اضافه شد.
در معیارهای ورود AFC و AMH بالا درست تعریف نشده بود. منظور از AFC بالا تعداد فولیوکلهای آنترال بالای 20 عدد و منظور از AMH سطح سرمی آنتی مولرین هورمون بالای 3ng/ml می باشد. همچنین پیامد ثانویه طرح نیز ثبت نشده بود که به لیست پیامدهای ثانویه اضافه شد.
Age 18-45
patients with polycystic ovary syndrome
high AMH and AFC
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
Age range of 18- to 45 patientsyears 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
سن ۱۸-۴۵
بیماران مبتلا به سندرم تخمدان پلی کیستیک
AMH, AFC بالا
محدوده سنی 18 تا45 سال
بیماران مبتلا به سندرم تخمدان پلی کیستیک
AMH, AFC بالا (تعداد فولیکولهای آنترال بالای 20 عدد و سطح سرمی آنتی مولرین هورمون بالای 3ng/ml )
سن ۱۸-۴۵محدوده سنی 18 تا45 سال بیماران مبتلا به سندرم تخمدان پلی کیستیک AMH, AFC بالا (تعداد فولیکولهای آنترال بالای 20 عدد و سطح سرمی آنتی مولرین هورمون بالای 3ng/ml )
Secondary outcomes
#1
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Checking the hematocrit level
Checking the hematocrit level
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بررسی سطح هماتوکریت
بررسی سطح هماتوکریت
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Three days after ovum-pick up day
Three days after ovum-pick up day
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سه روز پس از عمل تخمک گیری
سه روز پس از عمل تخمک گیری
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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.
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.
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5 سی سی خون در حالت ناشتا گرفته می شود و ﻣﯿﺰان ﻫﻤﺎﺗﻮکرﯾﺖ در آزﻣﺎﯾﺸگاه ﺑﯿﻤﺎرﺳﺘﺎن آرش و ﺑﺎ دﺳﺘگاه (کاﻧﺘﺮﺳﯿﺴﻤکس کااس-500 آی) اﻧﺪازه گیری خواهد ﺷﺪ، ﺿﻤنا اﯾﻦ دﺳﺘگاه ﻫﺮ روز ﺻﺒﺢ ﺗﻮﺳﻂ کارﺷﻨﺎس ﻣﺴﺌﻮل کاﻟﯿﺒﺮه میشود.
5 سی سی خون در حالت ناشتا گرفته می شود و ﻣﯿﺰان ﻫﻤﺎﺗﻮکرﯾﺖ در آزﻣﺎﯾﺸگاه ﺑﯿﻤﺎرﺳﺘﺎن آرش و ﺑﺎ دﺳﺘگاه (کاﻧﺘﺮﺳﯿﺴﻤکس کااس-500 آی) اﻧﺪازه گیری خواهد ﺷﺪ، ﺿﻤنا اﯾﻦ دﺳﺘگاه ﻫﺮ روز ﺻﺒﺢ ﺗﻮﺳﻂ کارﺷﻨﺎس ﻣﺴﺌﻮل کاﻟﯿﺒﺮه میشود.
#2
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Abdominal circumference
Abdominal circumference
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اندازه گیری دور شکم
اندازه گیری دور شکم
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Three days after ovum-pick up day
Three days after ovum-pick up day
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سه روز پس از عمل تخمک گیری
سه روز پس از عمل تخمک گیری
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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.
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.
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دور شکم در نقطه میانی خط بین دنده یا حاشیه دنده ای و تاج ایلیاک در خط میانی آگزیلاری با متر نواری اندازه گیری می شود.
دور شکم در نقطه میانی خط بین دنده یا حاشیه دنده ای و تاج ایلیاک در خط میانی آگزیلاری با متر نواری اندازه گیری می شود.
#3
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Patient’s satisfaction
Patient’s satisfaction
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رضایت بیمار
رضایت بیمار
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2 weeks after ovum-pick up day
2 weeks after ovum-pick up day
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2 هفته پس از عمل تخمک گیری
2 هفته پس از عمل تخمک گیری
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Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.
Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.
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رضایت بیمار با مقیاس کلامی ضعیف، رضایت بخش، خوب از طریق تماس تلفنی ارزیابی می شود.
رضایت بیمار با مقیاس کلامی ضعیف، رضایت بخش، خوب از طریق تماس تلفنی ارزیابی می شود.
#4
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Serum creatinine level
Serum creatinine level
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سطح سرمی کراتینین
سطح سرمی کراتینین
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Three days after ovum-pick up day
Three days after ovum-pick up day
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سه روز پس از عمل تخمک گیری
سه روز پس از عمل تخمک گیری
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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 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.
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5 سی سی خون در حالت ناشتا از بیمار گرفته می شود و ﻣﯿﺰان کراتینین سرم در آزﻣﺎﯾﺸگاه ﺑﯿﻤﺎرﺳﺘﺎن آرش و ﺑﺎ استفاده از دﺳﺘگاه هیتاچی717 و روش ژافه اﻧﺪازه گیری خواهد ﺷﺪ.
5 سی سی خون در حالت ناشتا از بیمار گرفته می شود و ﻣﯿﺰان کراتینین سرم در آزﻣﺎﯾﺸگاه ﺑﯿﻤﺎرﺳﺘﺎن آرش و ﺑﺎ استفاده از دﺳﺘگاه هیتاچی717 و روش ژافه اﻧﺪازه گیری خواهد ﺷﺪ.
#5
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Serum sodium and potassium levels
Serum sodium and potassium levels
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سطح سرمی سدیم و پتاسیم
سطح سرمی سدیم و پتاسیم
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Three days after ovum-pick up day
Three days after ovum-pick up day
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سه روز پس از عمل تخمک گیری
سه روز پس از عمل تخمک گیری
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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.
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.
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5 سی سی خون در حالت ناشتا از بیمار گرفته می شود و ﻣﯿﺰان سرمی سدیم وپتاسیم در آزﻣﺎﯾﺸگاه ﺑﯿﻤﺎرﺳﺘﺎن آرش و ﺑﺎ استفاه از دستگاه اتوماتیک الکترولیت آنالایزر کمپانی اودیکام و روش الکترود انتخابی یونی (ISE) اﻧﺪازه گیری خواهد ﺷﺪ.
5 سی سی خون در حالت ناشتا از بیمار گرفته می شود و ﻣﯿﺰان سرمی سدیم وپتاسیم در آزﻣﺎﯾﺸگاه ﺑﯿﻤﺎرﺳﺘﺎن آرش و ﺑﺎ استفاه از دستگاه اتوماتیک الکترولیت آنالایزر کمپانی اودیکام و روش الکترود انتخابی یونی (ISE) اﻧﺪازه گیری خواهد ﺷﺪ.
Protocol summary
Study aim
Comparison of the effect of two methods of cabergoline administration to prevent Ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome.
Design
This study is designed as a randomized, single-blind clinical trial with parallel groups with a sample size of 100 individuals per group
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Ovarian hyperstimulation syndrome
General information
Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2023-05-30, 1402/03/09
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of the effect of two cabergoline administration methods to prevent ovarian hyperstimulation syndrome (OHSS) in patients with polycystic ovary syndrome (PCO) under IVF
Public title
Comparison of the effect of two methods of cabergoline administration to prevent ovarian hyperstimulation syndrome in women with polycystic ovary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Vice-Chancellor in Research Affairs-Tehran University of Medical Science, 6th floor, near Qods st, keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.806
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Ovarian hyperstimulation syndrome
Timepoint
Three days after pancture
Method of measurement
Ultrasound and clinical findings
Secondary outcomes
1
Description
Checking the hematocrit level
Timepoint
Three days after ovum-pick up day
Method of measurement
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
Description
Abdominal circumference
Timepoint
Three days after ovum-pick up day
Method of measurement
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
Description
Patient’s satisfaction
Timepoint
2 weeks after ovum-pick up day
Method of measurement
Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.
4
Description
Serum creatinine level
Timepoint
Three days after ovum-pick up day
Method of measurement
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
Description
Serum sodium and potassium levels
Timepoint
Three days after ovum-pick up day
Method of measurement
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
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women’s Hospital
Full name of responsible person
Ashraf Moini
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
hosp_arash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Fotohi
Street address
Unit 601, Sixth floor, Keshavrz Blvd., Ghods Ave., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?