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Investigation of the therapeutic effect of Dapagliflozin in infertile women with polycystic ovary syndrome (PCOS) undergoing IVF

Protocol summary

Study aim
In this study, we will examine the effect of dapagliflozin-metformin with two drugs metformin and dapagliflozin in PCOS patients undergoing IVF treatment.
Design
A randomized, double-arm, parallel-group clinical trial with a design of 80 patients will be enrolled between April 2024 to September 2024.
Settings and conduct
This study is carried out in Mavold Infertility Clinic, Zahedan University of Medical Sciences Hospital. Patients are placed in the IVF treatment cycle using the gonadotropin-releasing hormone (GNRH) antagonist protocol. The patients in 4 groups received the drugs 2 months before the start of the ovulation cycle, and the drug treatment continued until the day of the puncture of the eggs. Medicines are given to patients by midwives, and both patient and doctor are blinded to the type of medicine.
Participants/Inclusion and exclusion criteria
Infertility due to polycystic ovary syndrome between the ages of 20 and 42 will be considered as a criterion for entering the study. Hypersensitivity to metformin or SGLT2 inhibitors, presence of other infertility factors, male infertility, congenital adrenal hyperplasia, thyroid gland disorder, Cushing's syndrome, pelvic organ pathology, hyperprolactinemia, androgen-secreting neoplasia, diabetes mellitus or taking drugs that affect carbohydrate metabolism. affects, the use of hormonal analogs other than progesterone two months before the start of the research and severe liver, kidney and pancreatitis diseases or gallstones will be considered as exclusion criteria.
Intervention groups
Patients are divided into 4 groups (20 people in each group). Group 1: Metformin 2 times a day. Group 2: dapagliflozin twice a day. Group 3: Dapagliflozin - metformin twice a day. Group 4: Placebo twice a day.
Main outcome variables
Examination of metabolic and hormonal factors, egg and embryo quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240303061157N1
Registration date: 2024-03-16, 1402/12/26
Registration timing: prospective

Last update: 2024-03-16, 1402/12/26
Update count: 0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Forogh Forghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3337 2013
Email address
f.forghani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the therapeutic effect of Dapagliflozin in infertile women with polycystic ovary syndrome (PCOS) undergoing IVF
Public title
Investigation of the therapeutic effect of Dapagliflozin in infertile women with polycystic ovary syndrome (PCOS) undergoing IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with classic polycystic ovary syndrome Infertile women between 20 and 42 years old
Exclusion criteria:
Hypersensitivity to metformin or SGLT-2 inhibitors Pregnancy Diabetes Male infertility
Age
From 20 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done with random sequences generated by the computer and concealment of random allocation was done with the method of sealed opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Dapagliflozin, metformin, dapagliflozin-metfosmin and placebo tablets are placed in similar containers and given to patients by midwives. Also, gynecologists do not know about the type of treatment received by the patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Zahedan University Of Medical Sciences
Street address
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.ZAUMS.REC.1402.440

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
no. of Oocyte retrieved
Timepoint
once, in day of puncture
Method of measurement
Oocyte retrieval was performed by ultrasound-guided transvaginal aspiration using a single-lumen needle.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Received oral rehydration salts (ORS) twice a day for 8 weeks
Category
Placebo

2

Description
Intervention group: Received Metformin drug with a dose of 1000 mg per day for 8 weeks
Category
Treatment - Drugs

3

Description
Intervention group: Received Dapagliflozin at a dose of 5 mg per day for 8 weeks
Category
Treatment - Drugs

4

Description
Intervention group: Receiving ِDapagliflozin 5 mg - metformin 1000 mg per day for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Moloud Infertility Center, Zahedan University of Medical Sciences Hospital
Full name of responsible person
Forough Forghani
Street address
Moloud Infertility Center, Ali Ibn Abitaleb (AS) Superspeciality Hospital, Salamat Blvd., Fars Gulf Highway, Zahedan, Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
info@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Habib Ghaznavi
Street address
Zahedan - Dr. Hasabi Square - Jennet Blvd - University of Medical Sciences campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
info@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Forogh Forghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Faculty of Medicine, Zahedan University of Medical Sciences, Khalij Fars Boulevard, Zahedan, IR Iran. Postal code: 9816743463, Cellphone number: 09128504061, Tel/Fax: +98 54 33372013
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2013
Fax
+98 54 3337 2013
Email
f.forghani@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Forogh Forghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Faculty of Medicine, Zahedan University of Medical Sciences, Khalij Fars Boulevard, Zahedan, IR Iran. Postal code: 9816743463, Cellphone number: 09128504061, Tel/Fax: +98 54 33372013
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2013
Fax
+98 54 3337 2013
Email
f.forghani@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Forogh Forghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Faculty of Medicine, Zahedan University of Medical Sciences, Khalij Fars Boulevard, Zahedan, IR Iran. Postal code: 9816743463, Cellphone number: 09128504061, Tel/Fax: +98 54 33372013
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2013
Fax
+98 54 3337 2013
Email
f.forghani@zaums.ac.ir

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
Yes - There is 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
Data such as metabolic factors, number of eggs, and embryos will be available.
When the data will become available and for how long
Access will start 12 months after printing.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will be made available for statistical analysis if all partners agree.
From where data/document is obtainable
Dr. Forghani Forghani- 09128504021- email Forghani_f@yahoo.com
What processes are involved for a request to access data/document
Data should be extracted from patient records and made available about 2 month later.
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