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Investigating the effect of the start time of dopamine agonist in antagonist cycles in reducing the rate of ovarian hyperstimulation syndrome

Protocol summary

Study aim
Investigating the effect of the start time of dopamine agonist in antagonist cycles in reducing the rate of ovarian hyperstimulation syndrome
Design
Clinical trial with control group, with parallel groups, unblinded, randomized.
Settings and conduct
In this study, about 124 people are randomly placed into two groups of 62 people. Unlike the control group, the intervention group is given a trigger with GnRH agonist. It is done in Shariati Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between the ages of 15 and 40, having at least one year of infertility history, patients with polycystic ovary syndrome using the Rotterdam criteria approved by the Rotterdam Joint Group in 2004. These criteria include having 17 or more follicles with a diameter of 10 mm or more on the trigger day, a peak estradiol level above 3,500 pg/ml, use of a GnRH antagonist protocol, use of a GnRH agonist, and cycles in which all embryos were cryopreserved. . Exclusion criteria: having a history of sensitivity to cabergoline and other dopamine agonists, having heart, kidney and liver disease, low response to ovarian stimulation and thus not being at risk of developing ovarian hyperstimulation syndrome, history of hyperprolactinemia.
Intervention groups
Intervention group: On the trigger day with GnRH agonist, they will receive cabergoline 0.5 mg orally once daily for 7 days. Control group: They will receive cabergoline 0.5 mg orally once daily for 7 days.
Main outcome variables
Reducing the rate of ovarian hyperstimulation syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240514061800N1
Registration date: 2024-05-18, 1403/02/29
Registration timing: prospective

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
shahedeh khansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4643 2157
Email address
b_sh2110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the start time of dopamine agonist in antagonist cycles in reducing the rate of ovarian hyperstimulation syndrome
Public title
Investigating the effect of the start time of dopamine agonist in antagonist cycles in reducing the rate of ovarian hyperstimulation syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 15 to 40, having at least one year of infertility history, patients with polycystic ovary syndrome using the Rotterdam criteria approved by the Rotterdam Joint Group in 2004. These criteria include having 17 or more follicles with a diameter of 10 mm or more on the trigger day, a peak estradiol level above 3,500 pg/ml, use of a GnRH antagonist protocol, use of a GnRH agonist, and cycles in which all embryos were cryopreserved. .
Exclusion criteria:
Having a history of sensitivity to cabergoline and other dopamine agonists, having heart, kidney, and liver disease, low response to ovarian stimulation and thus not being at risk of developing ovarian hyperstimulation syndrome, history of hyperprolactinemia.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1403.025

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with female factors

Primary outcomes

1

Description
Reducing the rate of ovarian hyperstimulation syndrome
Timepoint
After the intervention
Method of measurement
Transvaginal ultrasound and estradiol level measurement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: On the trigger day with GnRH agonist, they will receive cabergoline 0.5 mg orally once daily for 7 days.
Category
Treatment - Drugs

2

Description
Control group: They will receive cabergoline 0.5 mg orally once daily for 7 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Unit, Shariati Hospital
Full name of responsible person
shahedeh khansari
Street address
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, North Karegar Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8800 8810
Email
Dr_sh_Kh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahedeh khansari
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
Dr_sh_Kh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahedeh khansari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Unit, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
Dr_sh_Kh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahedeh khansari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Unit, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
Dr_sh_Kh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahedeh khansari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Unit, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
Dr_sh_Kh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
No other condition is considered
From where data/document is obtainable
Dr_sh_Kh@yahoo.com
What processes are involved for a request to access data/document
1 year
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