Protocol summary

Study aim
Comparing the effects of cabergoline and hydroxychloroquine to prevent ovarian hyperstimulation syndrome in Polycystic ovary syndrome patients undergoing infertility treatment.
Design
The studied sample is among infertile women who are candidates for assisted reproductive techniques referring to Arash Hospital, who will be selected based on the entry criteria and will be divided into two intervention groups using the random allocation method. We designed this study as a pilot with 20 people in each group.
Settings and conduct
This study will be conducted as a clinical trial. In this study, 40 pregnant women candidates for assisted reproductive techniques referred to Arash Hospital will be selected and randomly divided into cabergoline group and hydroxychloroquine group. The study will be conducted in a triple blind manner and the patients, the evaluating doctor and the statistical analyst will not know about the allocation of people to the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having polycystic ovary syndrome according to the Rotterdam criteria Age 18 to 40 years Number of antral follicles (AFC) above 20 AMH>3.36 ng/ml BMI <30 kg/m2 Exit criteria: Suffering from endometriosis Decreased ovarian reserve Chromosomal abnormalities History of sensitivity to drugs that inhibit dopamine or cabergoline Also, patients who do not take the desired drugs on a daily basis and those who have allergic symptoms or drug side effects will be excluded from the study.
Intervention groups
The examined samples will be selected based on the inclusion criteria and will be randomly divided into cabergoline and hydroxychloroquine groups. Both groups are under ART with antagonist cycle.
Main outcome variables
Incidence of Ovarian Hyperstimulation Syndrome as the primary and blood levels of urea, creatinine, sodium and potassium as secondary outcomes.

General information

Reason for update
Acronym
OHSS,PCOS
IRCT registration information
IRCT registration number: IRCT20240305061171N1
Registration date: 2024-06-29, 1403/04/09
Registration timing: retrospective

Last update: 2024-06-29, 1403/04/09
Update count: 0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Elnaz Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3426 3921
Email address
dr.elnazz.salari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of cabergoline and hydroxychloroquine to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS patients undergoing infertility treatment.
Public title
Comparing the effects of cabergoline and hydroxychloroquine to prevent ovarian hyperstimulation syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Polycystic ovary syndrome according to Rotterdam criteria Age 18 to 40 years The number of antral follicles (AFC) above 20 Anti-Müllerian hormone (AMH) more than 3.36 ng/ml Body mass index (BMI) less than 30 kg/m2
Exclusion criteria:
Suffering from endometriosis Decreased ovarian reserve Chromosomal abnormalities History of sensitivity to drugs that inhibit dopamine or cabergoline Patients who do not take the desired drugs on a daily basis
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization In this method, we use simple randomization models such as the use of a table of random numbers or the use of computer randomization methods, and we place each client in the intervention or control group. One of the advantages of this type of randomization is that the type of treatment assigned to the two groups is completely unpredictable and according to the probability theory, it can be guaranteed that in a large number, the sample size of the study will be the same in the intervention and control groups. Also, the implementation of this method is very simple.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be conducted in a triple blind study and the patients, the evaluating doctor and the statistical analyst will not know about the allocation of people to the intervention and control groups. In a triple blind study, the participant, the researcher, and the statistical consultant are all unaware of the arrangement of the groups. The way to conduct triple-blind studies is that there is an external observer in this studies who assigns common names such as: A and B to the drug (intervention) and placebo (control).
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
Resalat highway, after Shahid Bagheri highway, Shahid Bagh Darnia St. (Rashid Shamali), corner of 162 Alley (Shahid Abdul Majid)
City
Tehran
Province
Tehran
Postal code
1653986961
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.699

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Primary outcome: Ovarian hyperstimulation syndrome (OHSS)
Timepoint
After the intervention
Method of measurement
Based on clinical criteria, ultrasound and tests performed

Secondary outcomes

1

Description
Secondary outcome: Blood creatinine level
Timepoint
Before starting the intervention, After the intervention
Method of measurement
Based on laboratory results

2

Description
Secondary outcome: Blood sodium level
Timepoint
Before starting the intervention, After the intervention
Method of measurement
Based on laboratory results

3

Description
Secondary outcome: Blood potassium level
Timepoint
Before starting the intervention, After the intervention
Method of measurement
Based on laboratory results

4

Description
Secondary outcome: Blood Hematocrit
Timepoint
Before starting the intervention, After the intervention
Method of measurement
Based on laboratory results

5

Description
Secondary outcome: Blood urea level
Timepoint
Before starting the intervention, After the intervention
Method of measurement
Based on laboratory results

Intervention groups

1

Description
Intervention group 1: administration of cabergoline. This group is under ART with antagonist cycle. At the beginning of the cycle, gonadotropin is used with a dose of 150 units, and in follow-up ultrasounds during the cycle, the dose of gonadotropin is adjusted according to the size of the follicle. The trigger in this study is GnRH agonist (1.5 dacc), which is done 36 hours after giving the PICKUP trigger. On the trigger day, 0.5 mg cabergoline is administered to this group for 8 days. In this study, Freez-all strategy is used for all embryos. Three days and 8 days after the pickup, clinical, laboratory and ultrasound symptoms are checked to check OHSS. The patient is told to refer to the doctor from the 8th day until the next menstrual period in case of any problems.
Category
Treatment - Drugs

2

Description
Intervention group 2: Administration of hydroxychloroquine. This group is under ART with antagonist cycle. At the beginning of the cycle, gonadotropin is used with a dose of 150 units, and in follow-up ultrasounds during the cycle, the dose of gonadotropin is adjusted according to the size of the follicle. The trigger in this study is GnRH agonist (1.5 cc dacc), which is done 36 hours after giving the PICKUP trigger. On the trigger day, this group is prescribed 400 mg of hydroxychloroquine for 8 days. In this study, Freez-all strategy is used for all embryos. Three days and 8 days after the pickup, clinical, laboratory and ultrasound symptoms are checked to check OHSS. The patient is told to refer to the doctor from the 8th day until the next menstrual period in case of any problems.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's General Hospital
Full name of responsible person
Ashraf moini
Street address
Resalat highway, after Shahid Bagheri highway, Shahid Baghdarnia St. (Rashid Shamali), corner of 162 Alley (Shahid Abdul Majid)
City
Tehran
Province
Tehran
Postal code
16539115981
Phone
+98 21 7788 3283
Email
hosp_arash@tums.ac.ir
Web page address
https://arash.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ashraf moini
Street address
Keshavarz Blvd., Qods Corner, Tehran University of Medical Sciences Headquarters
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
stat@tums.ac.ir
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
Elnaz Salari
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Resalat highway, after Shahid Bagheri highway, Shahid Baghdarnia St. (Rashid Shamali), corner of 162 Alley (Shahid Abdul Majid)
City
Tehran
Province
Tehran
Postal code
16539115981
Phone
+98 21 7788 3283
Email
dr.elnazz.salari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Salari
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Pars West. East Farjam. Rashid St. Arash Women's General Hospital
City
Tehran
Province
Tehran
Postal code
16539115981
Phone
+98 34 3426 3921
Fax
Email
dr.elnazz.salari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Salari
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Pars West. East Farjam. Rashid St. Arash Women's General Hospital
City
Tehran
Province
Tehran
Postal code
16539115981
Phone
+98 34 3426 3921
Fax
Email
dr.elnazz.salari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information related to the main outcome or similar, can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Since the data related to patients is confidential, under the conditions that a person has a study in line with us and by maintaining the confidentiality of the data, she/he can request the use of the data.
From where data/document is obtainable
Dr. Elnaz Salari Address: Resalat Highway, after Shahid Bagheri Highway, Shahid Bagh Darnia St. (Rashid Shamali), corner of 162 Alley (Shahid Abdul Majid), Arash Women's General Hospital Postal code 16539115981 Phone 02177883283
What processes are involved for a request to access data/document
.After the request, if the executors and the sponsor agree to the request, the documents will be provided to the requester after about 3 months.
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