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Comparison of the effect of metformin and the combination of acid folic and myo-inositol in infertility patients with poly cystic ovary syndrom (PCOS) who undergoing IVF for the test time.

Protocol summary

Study aim
-Comparison on the BMI -Comparison on the fertilization rate -Comparison on the ovum count-Comparison on the ovum quality-Comparison on the embryo count -Comparison on the embryo quality -Comparison follicle count-Comparison on the follicle size -Comparison on the EP rate-Comparison on the abortion rate-Comparison on the OHSS rate
Design
two arm parallel group randomized trial with double bind , phase 3 on 140 patient
Settings and conduct
After patients entered the study and obtained informed consent in the infertility clinic of Yas Hospital and recorded demographic information including age, weight, height, body mass index, duration of infertility, type of infertility, history of abortion and EP and random drug selection by infertility resident and starting from three month before IVF cycle until ovum puncture,the size and count of follicles recorded by trans vaginal ultrasound .then performed IVF in IVF operating room of Yas Hospital.patients followed for pregnancy by beta HCG and ultrasound,as well as for abortion and EP. OHSS were carefully monitored for event during the cycle. In this study, the drug was prescribed by a resident of the infertility clinic after random selection and the researcher and the statistical unit did not interfere in this process and were not aware and blinding was performed
Participants/Inclusion and exclusion criteria
Infertile women with PCOS who were scheduled to undergoing IVF and had no other cause of infertility.
Intervention groups
Control group: Consumers of metformin as an old and common drug Intervention group: Consumers of a new drug combining myo-inosito and acid folic
Main outcome variables
BMI, ovum count, ovum quality, embryo count, embryo quality, follicle size, follicle count, fertilization rate, abortion rate, EP rate, OHSS rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201219049758N1
Registration date: 2021-01-02, 1399/10/13
Registration timing: retrospective

Last update: 2021-01-02, 1399/10/13
Update count: 0
Registration date
2021-01-02, 1399/10/13
Registrant information
Name
Fereshteh Rastegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4403 4589
Email address
rastegasr.freshteh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2018-10-02, 1397/07/10
Actual recruitment end date
2020-02-09, 1398/11/20
Trial completion date
2020-06-17, 1399/03/28
Scientific title
Comparison of the effect of metformin and the combination of acid folic and myo-inositol in infertility patients with poly cystic ovary syndrom (PCOS) who undergoing IVF for the test time.
Public title
Comparison effect of Metformin and combination of acid folic and myo-inositol" in poly cystic ovary syndrome"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First IVF No histoty of ovarian manipulation Lack of male infertility factor Patency of fallupian tubes No history of smoking
Exclusion criteria:
History of IVF histoty of ovarian manipulation male infertility factor No patency of fallupian tubes history of smoking
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Actual sample size reached: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule:First, 70 letters A and 70 letters B were written on special papers that were not marked inside. Then all of them were placed in a bag and for each patient, after obtaining informed consent, a paper was removed randomly and without replacement, and based on the letter written on it, the desired intervention was performed for the patient. In addition, interventions A or B were determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed as double-blind, the researcher and the analyzer do not know the type of treatment. The drug is used by the infertility resident physician for the patient after random selection.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Deputy of research , First floor, Building number 1, Faculty of Medicine, Norethern entrance of Tehran University of Medical Science, Poursina Streat, Qods Street, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.TUMS. MEDICIN. REC.1399.766

Health conditions studied

1

Description of health condition studied
Infertility, Polycystic ovary syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Improving fertility in patients with polycystic ovary syndrome
Timepoint
Before starting the drug from three months before the start of the IVF cycle until the puncture and then before the puncture then comparison of two drug in fertilization rate
Method of measurement
HCG, Ultrasound

Secondary outcomes

1

Description
Body Mass Index, Fertilization rate, Abortion rate, EP rate, OHSS rate, Ovum count, Ovum quality, Embryo count, , Embryo quality, Follicle count,Follicle size
Timepoint
Patients took the drug three months before the start of the IVF cycle until the puncture, Body Mass Index was measured before and after the drug was completed.
Method of measurement
Body Mass Index: weight(kg) on height(cm2), Fertility: HCG and ultrasound, Abortion: HCG and ultrasound, EP: HCG and ultrasound, OHSS: ultrasound, Follicle size: ultrasound, Follicle count: ultrasound, ovum count: microscopic and embryologist, ovum quality: microscopic and embryologist, Embryo count: microscopic and embryologist, Embryo quality: microscopic and embryologist

Intervention groups

1

Description
Intervention group: Received combination of 2000 mg and 200 micro gr Folic acid twice a day
Category
Treatment - Drugs

2

Description
Control group: Received 500 mg three time a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas Haspital
Full name of responsible person
zahra rezaee
Street address
Yas Hospital, Next to the sarv street, Northern Nejatollahi Street, Karim khan Aven
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Email
zhrrezaee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rezaee
Street address
Yas Hospital, Next to the sarve street,Northern Nejatollahi street, karim khan Aven
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
zhrrezaee@yahoo.com
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
Fereshteh rastegar
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.10, Yas steet., Norhtern Vafa azar Aven, West Ferdows Blvn,
City
Tehran
Province
Tehran
Postal code
1481863373
Phone
+98 21 4403 4589
Email
rastegar.freshteh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra rezee
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital, Next to the sarv street, Norhtern Nejatollahi Karimkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
zhrrezee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Feizabad
Position
Sprcialist
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Yas Hospital, Next to the sarv street, Northern Nejatollahi, Karimkhan Aven
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
009898718311
Email
elhamfeizabad@gmail.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
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified participant
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr.Rezaee and my analysis done with must be done with her opinion .
From where data/document is obtainable
Dr. Zahra rezee
What processes are involved for a request to access data/document
Any reqeust must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Rezee
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