Comparing the therapeutic effect of Melijent-M and Synoripa on infertile women with polycystic ovary syndrome undergoing Sperm intracytoplasmic injection
In this study, we examine the effect of linagliptin-metformin and empagliflozin-metformin with metformin in patients with polycystic ovary syndrome treated with intracytoplasmic sperm injection.
Design
Clinical trial patients are divided into 4 groups (20 people in each group). Group 1: Metformin 2 times a day. Group 2: linagliptin-metformin twice a day. Group 3: empagliflozin- metformin twice a day. Group 4: Placebo twice a day
In a double-blind manner, randomization will be done on 80 patients in phase 2 by preparing a simple table with a computer and a random sealed envelope method.
Settings and conduct
This study is conducted in Moulud Infertility Clinic of Zahedan University of Medical Sciences. 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. Medications are given to patients by midwives, and both patient and physician are blinded to the type of medication using a simple computer table and sealed envelope randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertility due to classic polycystic ovary syndrome and between the ages of 25 and 35.
Exclusion criteria: Patients with hypersensitivity to metformin or inhibitors of dipeptidyl peptidase-4 and sodium glucose cotransporter-2, congenital adrenal hyperplasia, thyroid gland disorder, Cushing's syndrome, hyperprolactinemia, androgen secreting neoplasia, Affects severe liver, kidney and pancreatitis diseases or gallstones
Intervention groups
Patients are divided into 4 groups (20 people in each group). Group 1: Metformin 2 times a day. Group 2: linagliptin-metformin twice a day. Group 3: empagliflozin-metformin twice a day. Group 4: Placebo twice a day
Main outcome variables
Egg and embryo quality, metabolic and hormonal factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241027063520N1
Registration date:2024-11-17, 1403/08/27
Registration timing:prospective
Last update:2024-11-17, 1403/08/27
Update count:0
Registration date
2024-11-17, 1403/08/27
Registrant information
Name
Mahdieh Sadat Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 342 6126
Email address
ms.mousavi98@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effect of Melijent-M and Synoripa on infertile women with polycystic ovary syndrome undergoing Sperm intracytoplasmic injection
Public title
Investigating the effect of two combined drugs with metformin in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility due to polycystic ovary syndrome
Patients with polycystic ovary syndrome aged 25 to 35
Exclusion criteria:
Patients with hypersensitivity to metformin
Patients with hypersensitivity to dipeptidyl peptidase-4 inhibitors
Patients with hypersensitivity to sodium glucose cotransporter-2
Male infertility
Patients with congenital adrenal hyperplasia
Patients with thyroid gland disorders
Patients with Cushing's syndrome
Patients with androgen secreting neoplasia
Severe liver diseases
Severe kidney diseases
Patients with gallstones
Age
From 25 years old to 35 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
The method of randomization will be done as a simple randomization, individually. The tool used is sealed envelopes, so that 80 sealed envelopes numbered from 1 to 80 are placed in a box. After accepting each of the patients and after obtaining informed consent, the treating doctor randomly removed one of the sealed envelopes inside the box (without seeing the contents of the box) and in this way the patients were categorized into different groups. they become
Inside the box, the drugs are divided into 4 groups: placebo, metformin, Meligent-M and Synoripa and are randomly placed in each envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Linagliptin-metformin, empagliflozin-metformin, metformin 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 Arak University
Street address
Shahid Beheshti St.
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.ARAKU.REC.1403.026
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
Investigation of changes in biochemical factors in blood serum
Timepoint
Measurement of biochemical factors before the patient started taking the drug and 8 weeks after taking the drug on the day of puncture.
Method of measurement
Using the ELISA kit
2
Description
Investigation of changes in hormonal factors in blood serum
Timepoint
Measurement of hormonal factors before the patient started taking the drug and 8 weeks after taking the drug on the day of puncture.
Method of measurement
Using the ELISA kit
Secondary outcomes
1
Description
The number of eggs obtained.
Timepoint
On the day of puncture, the patient's egg count is checked.
Method of measurement
Oocyte collection by ultrasound-guided transvaginal aspiration using a single-lumen needle
Intervention groups
1
Description
Control group: with Oral rehydration solutions(ORS) (Porsina, placebo, Iran) twice a day for 8 weeks
Category
Placebo
2
Description
Intervention group: receiving metformin (500 mg twice a day) for 8 weeks
Category
Treatment - Drugs
3
Description
Intervention group: receiving Meligent-M (linagliptin-metformin) 2.5/500 mg twice a day for 8 weeks
Category
Treatment - Drugs
4
Description
Intervention group: receiving Synoripa (empagliflozin-metformin) 5/500 mg twice a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Moloud Infertility Treatment Clinic, Zahedan University of Medical Sciences
Full name of responsible person
Mahdieh Sadat Mousavi
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
Arak University
Full name of responsible person
Hamed Safikhani
Street address
Arak university, Karbala Blvd., Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
p-r@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak University
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
Arak University
Full name of responsible person
Mahdieh Sadat Mousavi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Developmental biology
Street address
No. 10, Pardisan 2, University St., Koi Asatid
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3349 1574
Email
ms.mousavi98@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Mahdieh Sadat Mousavi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Developmental biology
Street address
No. 10, Pardisan 2, University St., Koi Asatid
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3349 1574
Email
ms.mousavi98@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Mahdieh Sadat Mousavi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Developmental biology
Street address
No. 10, Pardisan 2, University St., Koi Asatid
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3349 1574
Email
ms.mousavi98@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
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.