Comparison of the effect of sitagliptin and metformin on oocyte and embryo quality, number of retrieved and fertilized oocyte and embryo the Polycystic ovary syndrome (PCOS) insulin-resistant women undergoing In vitro fertilization (IVF)
Comparison of the effect of Sitagliptin and Metformin on oocyte and embryo quality, number of retrieved and fertilized oocyte and embryo the PCO insulin-resistant women undergoing IVF
Design
Clinical trial, with parallel groups, double-blind, phase three, randomized, where 90 patients will be randomly assigned to two groups of 45 people with the size of blocks of 8.
Settings and conduct
The studied population are women aged 18-40 referring to the Fatima Zahra Infertility Research Center of Babol. Patients are randomly divided into two intervention groups by block method.
Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day
Intervention group 2: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day
Participants/Inclusion and exclusion criteria
Diagnosis of PCOS based on Rotterdam criteria؛ Age 18 to 40 years؛ BMI≥20؛ Insulin resistant؛ IVF candidate؛ Not taking drugs that are effective on the activity of two drugs at this time in the last 3 months؛ Not taking weight-loss drugs or having any slimming diet or regular aerobic exercise in the last 3 months؛ Not receiving assisted reproductive treatments in the last 3 months
Exclusion Criteria: Getting pregnant during the study؛ The patient's lack of consent to enter or the patient's lack of cooperation in taking the medicine؛ smoking
Intervention groups
Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day
Intervention group 2: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day
Main outcome variables
oocyte and embryo quality (average number of recovered, fertilized oocyte and embryos formed with excellent quality)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220803055607N1
Registration date:2022-08-04, 1401/05/13
Registration timing:prospective
Last update:2022-08-04, 1401/05/13
Update count:1
Registration date
2022-08-04, 1401/05/13
Registrant information
Name
Farimah Mohammadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8301
Email address
f.mohammadian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-13, 1401/05/22
Expected recruitment end date
2023-08-13, 1402/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sitagliptin and metformin on oocyte and embryo quality, number of retrieved and fertilized oocyte and embryo the Polycystic ovary syndrome (PCOS) insulin-resistant women undergoing In vitro fertilization (IVF)
Public title
The effect of sitagliptin and metformin on the quality of oocyte and embryos, the number of retrieved oocyte
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Polycystic ovary syndrome (PCOS) based on Rotterdam criteria
Age 18 to 40 years
BMI≥20
Insulin resistant
In vitro fertilization (IVF) candidate
Not taking drugs that are effective on the activity of two drugs at this time in the last 3 months
Not taking weight-loss drugs or having any slimming diet or regular aerobic exercise in the last 3 months
Not receiving assisted reproductive treatments in the last 3 months
Exclusion criteria:
Getting pregnant during the study
The patient's lack of consent to enter or the patient's lack of cooperation in taking the medicine
smoking
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to two groups of 45 using a block of 8 and a ratio of 1:1. In order to generate the allocation sequence, the free website com.randomization.www will be used. The obtained sequence will be written on separate sheets and will be placed in closed envelopes and will be provided to the main researcher to conduct the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines are in capsule form. For the purpose of blinding, the capsules containing sitagliptin are chosen to be completely identical to metformin capsules so that they are completely similar in terms of smell, color and shape. The capsules containing these drugs are placed in cans of the same shape and size, and then a 3-digit code is written on each can. After the patient enters the study, one of these cans is assigned to the patient and the code on the can is on the patient file (study checklist) is written. Opening the codes will be done after completing the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Siences
Street address
Babol University of Medical Sciences, Gangafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
471764136
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.115
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 and embryo quality
Timepoint
Two months after the start of the intervention
Method of measurement
The average number of retrieved oocyte, fertilized and formed embryos with excellent quality
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day
Category
Treatment - Drugs
2
Description
Intervention group: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Marmar Firouzpour
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center، Noshirvani St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1227 4881
Email
ngh_pa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sedigheh Esmaeilzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
s.esmaeilzadeh@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sedigheh Esmaeilzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
s.esmaeilzadeh@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farimah Mohammadian
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
f.mohammadian@mubabol.ac.ir
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