Protocol summary

Study aim
Comparison of Mean Levels of Testosterone, Cholesterol, Triglyceride, Oocyte Quality, Embryo Quality, BMI, LH, FSH in Two Groups Treated with Inositol and Sitagliptin Addition to Inositol
Design
The Clinical Trial, One Control Group with a Parallel Group,double Blind, Randomized, Phase 3 on 70 Patients who will be Randomized with Block Method
Settings and conduct
Body Mass Index and Levels of Fating Blood Sugar, Luteinizing Hormone & Follicle-Stimulation Hormone, Triglyceride, Cholesterol and Testosterone are Evaluated Before Starting in Both Groups. Group A will Receive their Routine Medications Plus Sitagliptin Tablet and Inofolic Powder, and Group B will Receive their Routine Medications Plus Inofolic Powder, 8 Weeks Before the Start of In Vitro Fertilization Cycle in the Infertility Center of Shahid Beheshti Hospital in Kashan, and then Embryo Transfer will be Done with Appropriate Quality. The Quality of Embryo and Oocyte and Laboratory Criteria and Body Mass Index will be Investigated in Two Groups
Participants/Inclusion and exclusion criteria
Inclusion Criteria People with Polycystic Ovarian Syndrome, Age Between 18 and 40 Years Old, Known Case of Polycystic Ovarian Syndrome, and Based on their Infertility Records, are Candidates for Entering the Cycle of Infertility Treatment and ICSI; Exclusion Criteria People with Uterine Abnormalities
Intervention groups
Group Treated with Inositol Group Treated with Inositol and Sitagliptin
Main outcome variables
Embryo Quality, Oocyte Quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240128060827N1
Registration date: 2024-02-11, 1402/11/22
Registration timing: prospective

Last update: 2024-02-11, 1402/11/22
Update count: 0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Mahdis Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5500 5363
Email address
mahdiis174@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-06-03, 1403/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Sitagliptin and Inositol on the Oocyte and Embryo Quality in Poly Cystic Ovarian Syndrome (PCOS) Patients Undergoing Intra Cytoplasmic Sperm Injection (ICSI)
Public title
Comparison the Effect of Sitagliptin and Inositol on the Fertility Treatment in Polycystic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Polycystic Ovarian Syndrome Age Between 18 and 40 Years People who are Known Case of Polycystic Ovarian Syndrome Based on Sonographic and Laboratory Findings Contained in the Case file People who are Candidates for Infertility Treatment and ICSI Based on Infertility Records
Exclusion criteria:
People with Uterine Abnormalities (such as Asherman's Syndrome, Fibroids, Polyps, and a Diagnosis of Adenomyosis) Contraindications for Inositol and Sitagliptin Treatment Cycles with Embryo Donation or Prenatal Genetic Screening Endometriosis and Infertility with Unknown Cause Severe Male Factor Infertility
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
First, the Drug Package of Sitagliptin and Inofolic was Coded with the Letter A and the Drug Package of Inofolic with the Letter B, and then using the Website www.sealdenvelope.com/simple-randomiser/v1/lists, the Randomization List was Selected by Selecting a Sample Size of 70. And it is Prepared by Balanced Quadruple Blocking Method. Then, through the obtained Randomization list, the People Included in the study will be Assigned to one of the two groups A and B. For example, suppose that in the first quartet block, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples will be assigned to group B, and it will continue in this way until the last sample
Blinding (investigator's opinion)
Single blinded
Blinding description
A person who has no Role in this Trial and is not Aware of the Random Allocation will Allocate the Drugs to thePparticipants, a code will be Placed on the box of the Drugs. The Researcher is Unaware of the Type of Intervention and After Analyzing the Data, the Package Codes will be Decoded. Considering that the Form of Drugs and their Consumption are not the same, one is in the form of Powder and the other is a Tablet, and Considering the Proven Therapeutic Effect of Inofolic Powder in the Treatment of Infertility, Placebo cannot be Considered.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi blv, Kashan Medical Science University
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.225

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
Oocyte Quality
Timepoint
8 Weeks Later Use of Medications
Method of measurement
Microscope

2

Description
Embryo Quality
Timepoint
8 Weeks Later Use of Medications
Method of measurement
Microscope

Secondary outcomes

1

Description
Body Mass Index
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Dividing Weight by Height to the Power of 2

2

Description
Luteinizing hormone
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
ELISA test

3

Description
Follicle stimulating hormone
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
ELISA test

4

Description
Fasting Blood Sugar
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
ELISA test

5

Description
Testosterone
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
ELISA test

Intervention groups

1

Description
Intervention group: Patients in the Intervention Group Received Sitagliptin Tablets 50 mg Every 12 Hours Made by Abidi Company and Inofolic Powder Including 2000 mg Myoinositol and 200 mcg Folic Acid Made by Teb Mofid Nikan Every 12 Hours with their Routine Medications for 8 Weeks Before the Start of the IVF Cycle and then Embryo Transfer will be Done with Appropriate Quality, Embryo and Oocyte quality and the Level of Laboratory Criteria (LH, FSH, FBS, Testosterone) and BMI will be Checked
Category
Treatment - Drugs

2

Description
Control group: Patients in the Control Group Received Inofolic Powder Including 2000 mg Myoinositol and 200 mcg Folic Acid Made by Teb Mofid Nikan Every 12 Hours with their Routine Medications for 8 Weeks Before the Start of the IVF Cycle and then Embryo Transfer will be Done with Appropriate Quality, Embryo and Oocyte quality and the Level of Laboratory Criteria (LH, FSH, FBS, Testosterone) and BMI will be Checked
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Mahdis Rajabi
Street address
Ghotbe Ravandi Blv, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715988111
Phone
+98 31 5500 9999
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Doctor Gholamali Hamidi
Street address
Tahghighat & Fanavari Moavenat , Kashan Medical Science University
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
hamiidi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fateme Foroozanfard
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Blv, Kashan Medical Science University
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
fatemehforoozanfard@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahdis Rajabi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Blv, Kashan Medical Science University
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
Mahdiis174@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahdis Rajabi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Blv, Kashan Medical science university
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
Mahdiis174@yahoo.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
Undecided - It is not yet known if there will be 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
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