Protocol summary
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Study aim
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The aim of this study is to determine the effect of Myo -inositol on fertility success in patients with IVF / ICSI cycles.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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The number of oocytes obtained; the number of embryos formed; the number of clinical pregnancies, Number of preterm births, number of abortions, number of live births
General information
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Reason for update
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Minor changes related to increasing the number of samples studied, increasing the number of outcomes studied
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181225042109N1
Registration date:
2019-05-09, 1398/02/19
Registration timing:
prospective
Last update:
2022-08-01, 1401/05/10
Update count:
4
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Registration date
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2019-05-09, 1398/02/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-22, 1398/03/01
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Expected recruitment end date
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2019-09-21, 1398/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Myo-inositol on pregnancy success in women with IVF/ICSI cycle
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Public title
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The effect of Myo-inositol on pregnancy success
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-02, 1397/09/11
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Ethics committee reference number
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IR.MUK.REC.1397.236
Health conditions studied
1
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Description of health condition studied
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Female infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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The number and quality of oocytes obtained
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Timepoint
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Two weeks after the intervention
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Method of measurement
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Using Sonography
2
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Description
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Number and quality of embryos formed
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Timepoint
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Third week after intervention
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Method of measurement
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Using Sonography
Secondary outcomes
1
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Description
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Number of clinical pregnancy
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Timepoint
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Clinical pregnancy was defined as a fetal cardiac activity in the 6th to 7th week of pregnancy.
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Method of measurement
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Sonography
2
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Description
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Miscarriage
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Timepoint
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Pregnancy loss earlier than the 20th week of gestation
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Method of measurement
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Observation and sonography
3
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Description
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Preterm delivery
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Timepoint
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It was measured during the pregnancy. Definition: Birth of the baby earlier than 37wk of the pregnancy.
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Method of measurement
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Observation and sonography
4
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Description
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Live birth
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Timepoint
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At the end of pregnancy
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Method of measurement
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Observation
Intervention groups
1
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Description
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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 since the onset of an agonist cycle or embryo transfer for 2 months
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sanandaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of the data on the primary outcome is for sharing.
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When the data will become available and for how long
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One year after the publication the data will be available.
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To whom data/document is available
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Researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Meta-analysis is allowed on the data of this study.
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From where data/document is obtainable
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Dr. Shahin Abbasi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: s.abbasi@muk.ac.ir
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What processes are involved for a request to access data/document
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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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Comments
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