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The effect of Myo-inositol on pregnancy success in women with IVF/ICSI cycle

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History
# Registration date Revision Id
5 2022-08-01, 1401/05/10 235320
4 2022-06-12, 1401/03/22 229737
3 2022-05-15, 1401/02/25 227835
2 2022-05-01, 1401/02/11 225163
1 2019-05-09, 1398/02/19 89408
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  • General information

    Infertility for at least one year
    Not using contraception
    Candidates for IVF / ICSI
    Minimum age of 20 years and a maximum of 40 years
    Agonist cycles
    Infertility for at least one year
    Not using contraception
    Candidates for IVF / ICSI
    Minimum age of 20 years and a maximum of 40 years
    Agonist cycles
    having a regular menstrual cycle (24-35 days)
    نازایی حداقل به مدت یکسال
    استفاده نکردن از روشهای جلوگیری از بارداری
    کاندید انجام IVF/ICSI
    داشتن سن حداقل 20 سال و حداکثر 40 سال
    سیکل های اگونیست
    نازایی حداقل به مدت یکسال
    استفاده نکردن از روشهای جلوگیری از بارداری
    کاندید انجام IVF/ICSI
    داشتن سن حداقل 20 سال و حداکثر 40 سال
    سیکل های اگونیست
    داشتن سیکل منظم قاعدگی (24 تا 35 روز)

  • Primary outcomes

    #1
    The number of oocytes obtained
    The number and quality of oocytes obtained
    تعداد تخمک های بدست آمده
    تعداد و کیفیت تخمک های بدست آمده
    #2
    Number of embryos formed
    Number and quality of embryos formed
    تعداد جنین های تشکیل شده
    تعداد و کیفیت جنین های تشکیل شده
    #3
    Number of clinical pregnancy
    empty
    تعداد باراری های کلینیکال
    empty
    Clinical pregnancy was defined as a fetal cardiac activity in the 6th to 7th wk of pregnancy using sonography
    empty
    هفته ششم تا هفتم بارداری با استفاده از سونوگرافی
    empty
    Sonography
    empty
    سونوگرافی
    empty
    #4
    Miscarriage
    empty
    سقط
    empty
    Pregnancy loss earlier than the 20th wk of gestation
    empty
    سقط جنین در طی بارداری قبل از هفته 20
    empty
    Observation and sonography
    empty
    مشاهده و سونوگرافی
    empty
    #5
    Preterm delivery
    empty
    تولد زودرس
    empty
    During the pregnancy, it was measured. Definition: Birth of a baby earlier than 37 wk gestation.
    empty
    در طی بارداری سنجش می شود. تعریف: تولد بچه قبل از هفته 37 بارداری
    empty
    Observation and sonography
    empty
    مشاهده و سونوگرافی
    empty
    #6
    Live birth
    empty
    تولد زنده
    empty
    At the end of pregnancy
    empty
    در انتهای بارداری
    empty
    Observation
    empty
    مشاهده
    empty

  • Secondary outcomes

    #1
    The number of clinical pregnancies
    Number of clinical pregnancy
    تعداد حاملگی های کلینیکال
    تعداد بارداری کلینیکال
    Third week after intervention
    Clinical pregnancy was defined as a fetal cardiac activity in the 6th to 7th week of pregnancy.
    هفته سوم پس از مداخله
    بارداری کلینیکی که به عنوان فعالیت قلب جنین در هفته های هفته ششم تا هفتم بارداری تعریف می شود.
    Based on Beta-HCG and ultrasound confirmation
    Sonography
    بر اساس تایید Beta-HCG و سونوگرافی
    سونوگرافی
    #2
    empty
    Miscarriage
    empty
    سقط
    empty
    Pregnancy loss earlier than the 20th week of gestation
    empty
    سقط جنین در طی بارداری قبل از هفته 20
    empty
    Observation and sonography
    empty
    مشاهده و سونوگرافی
    #3
    empty
    Preterm delivery
    empty
    تولد زودرس
    empty
    It was measured during the pregnancy. Definition: Birth of the baby earlier than 37wk of the pregnancy.
    empty
    در طی بارداری سنجش می شود. تعریف: تولد بچه قبل از هفته 37 بارداری
    empty
    Observation and sonography
    empty
    مشاهده و سونوگرافی
    #4
    empty
    Live birth
    empty
    تولد زنده
    empty
    At the end of pregnancy
    empty
    در انتهای بارداری
    empty
    Observation
    empty
    مشاهده

  • Intervention groups

    #1
    Control group: Administration of placebo daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital with the onset of OCP since the onset of an agonist cycle or embryo transfer for 2 months.
    Control group: Administration of placebo daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital at the onset of an agonist cycle or embryo transfer for 2 months.
    گروه کنترل: تجویز پلاسبو روزانه به بیماران کاندید ICSI/IVF مراجعه کننده به کلینیک نازایی بیمارستان بعثت همراه با شروع OCP از ابتدای شروع سیکل اگونیستی یا زمان انتقال جنین به مدت 2ماه .
    گروه کنترل: تجویز پلاسبو روزانه به بیماران کاندید ICSI/IVF مراجعه کننده به کلینیک نازایی بیمارستان بعثت از ابتدای شروع سیکل اگونیستی یا زمان انتقال جنین به مدت 2ماه .

Protocol summary

Study aim
The aim of this study is to determine the effect of Myo -inositol on fertility success in patients with IVF / ICSI cycles.
Design
In this single blinded randomized clinical trial, the researcher goes to the infertility clinic daily. Each patient who has inclusion criteria to enroll in the study is considered as a sample. Samples were divided into 2 groups A and B by computer random selection. Patients were randomly divided into two intervention and control groups based on randomized block method. Total of 50 patients were enrolled.
Settings and conduct
This clinical trial is carried out at the Infertility Clinic of Besat Hospital in Sanandaj. Patients are unaware of how they are grouped and blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study included: Infertility for at least one year, not using contraception, candidates for IVF / ICSI, minimum age of 20 years and a maximum of 40 years, Agonist cycles.Exclusion criteria for the study included: Underlying disease, uterine Anomaly, freeze embryo transfer cycle, history of repeated abortions.
Intervention groups
Administration of 2000 mg Myo-inositol plus 200 mg of folic acid daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital
Main outcome variables
The number of developed follicles; number of oocytes obtained; number of embryos formed; number of clinical pregnancies, Number of preterm births, number of abortions, number of live births

General information

Reason for update
Minor changes related to increasing the number of samples studied, increasing the number of outcomes studied
Acronym
IRCT registration information
IRCT registration number: IRCT20181225042109N1
Registration date: 2019-05-09, 1398/02/19
Registration timing: prospective

Last update: 2022-06-13, 1401/03/23
Update count: 4
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Shahin Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4675
Email address
s.abbasi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Myo-inositol on pregnancy success in women with IVF/ICSI cycle
Public title
The effect of Myo-inositol on pregnancy success
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility for at least one year Not using contraception Candidates for IVF / ICSI Minimum age of 20 years and a maximum of 40 years Agonist cycles having a regular menstrual cycle (24-35 days)
Exclusion criteria:
Underlying disease Uterine Anomaly Freeze embryo transfer cycle History of repeated abortions Women with any underlying diseases such as metabolic or endocrine disorders and uterine anomaly
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher goes to the clinic daily. Each patient who has inclusion criteria to enroll in the study is considered as a sample. Samples are divided into 2 groups A and B by computer random selection.Patients are randomly divided into two intervention and control groups based on randomized block method, for example: ABAB / AABB / BBAA.
Blinding (investigator's opinion)
Double blinded
Blinding description
Women in the study and outcome assessors are unaware of how they are grouped. The appearance of the drug will be the same for both intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.MUK.REC.1397.236

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Number of developed follicles
Timepoint
Two weeks after the intervention
Method of measurement
Using Sonography

2

Description
The number and quality of oocytes obtained
Timepoint
Two weeks after the intervention
Method of measurement
Using Sonography

3

Description
Number and quality of embryos formed
Timepoint
Third week after intervention
Method of measurement
Using Sonography

Secondary outcomes

1

Description
Number of clinical pregnancy
Timepoint
Clinical pregnancy was defined as a fetal cardiac activity in the 6th to 7th week of pregnancy.
Method of measurement
Sonography

2

Description
Miscarriage
Timepoint
Pregnancy loss earlier than the 20th week of gestation
Method of measurement
Observation and sonography

3

Description
Preterm delivery
Timepoint
It was measured during the pregnancy. Definition: Birth of the baby earlier than 37wk of the pregnancy.
Method of measurement
Observation and sonography

4

Description
Live birth
Timepoint
At the end of pregnancy
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: Administration of 2000 mg myo-inositol plus 200 mg of folic acid daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital with the onset of OCP since the onset of an agonist cycle or embryo transfer for 2 months
Category
Treatment - Drugs

2

Description
Control group: Administration of placebo daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital at the onset of an agonist cycle or embryo transfer for 2 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Shahin Abbasi
Street address
Keshavarz St, Besat Hospital, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66186-34683
Phone
+98 87 3328 5910
Email
s.abbasi@muk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Street address
Pasdaran St.,Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Mozh.zarei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Shahin Abbasi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
s.abbasi@muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fariba Seyedoshohadaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz St, Besat Hospital, sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3328 5910
Email
f.seyedoshohadaei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shahin Abbasi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
s.abbasi@muk.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
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
Yes - There is 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
Not applicable
Title and more details about the data/document
Part of the data on the primary outcome is for sharing.
When the data will become available and for how long
One year after the publication the data will be available.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Meta-analysis is allowed on the data of this study.
From where data/document is obtainable
Dr. Shahin Abbasi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: s.abbasi@muk.ac.ir
What processes are involved for a request to access data/document
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email .
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