Comparison of the effect of Myoinositol with the control group on the outcomes of assisted reproductive treatments in patients with polycystic ovary syndrome
Comparison of the effect of Myoinositol with the control group on the outcomes of assisted reproductive treatments in patients with polycystic ovary syndrome
Design
This controlled, parallel-group, single-blinded, phase 3 clinical trial is conducted on 98 infertile women. Random allocation rule is used for randomization.
Settings and conduct
This study is conducted on women diagnosed with polycystic ovary syndrome who referred to Yas Hospital Complex. In the intervention group, they receive myoinositol powder 4 grams per day for 8 weeks, and the control group receives folic acid tablet 400 mg per day for 8 weeks, and then both groups enter the ovulation cycle.
Participants/Inclusion and exclusion criteria
Infertile women aged 20 to 38 years and diagnosed with polycystic ovary syndrome according to ESHRE-ASRM Rotterdam criteria are included in the study. Women with endometriosis, hydrosalpinx, and women with body mass index higher than 35 are excluded from the study.
Intervention groups
The intervention group receives myoinositol powder 4 grams per day for 8 weeks and the control group receives folic acid tablet 400 mg per day for 8 weeks and then both groups enter the ovulation cycle.
Main outcome variables
Ovum quality and number, embryo quality and clinical pregnancy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240119060732N2
Registration date:2024-06-29, 1403/04/09
Registration timing:prospective
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Firoozeh Akbari Asbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4216 0852
Email address
fasbagh_md@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Myoinositol with the control group on the outcomes of assisted reproductive treatments in patients with polycystic ovary syndrome
Public title
The effect of Myoinositol on the outcomes of assisted reproductive treatments in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome according to ESHRE-ASRM criteria
Infertile women
Exclusion criteria:
Body mass index above 35
Endometriosis
Azospermia
Sever oligospermia
Hydrosalpinx
Age
From 20 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 49 letters A and 49 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The doctor investigating the outcomes does not know the type of treatment of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethic commitee of Tehran University of Medical sciences
Street address
Ethics committee of Tehran University of Medical Sciences, Poursina St., Qods St., Kesahvarz Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2023-05-23, 1402/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.113
Health conditions studied
1
Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
The oocyte quality
Timepoint
Once, at the puncture day
Method of measurement
The embryologist reports
2
Description
The oocyte number
Timepoint
Once, at the puncture day
Method of measurement
The embryologist reports
3
Description
The embryo quality
Timepoint
Once, at the puncture day
Method of measurement
The embryologist reports
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Once, six weeks after fetal transfer
Method of measurement
Ultrasound
Intervention groups
1
Description
Intervention group: They receive myoinositol powder 4 grams per day for 8 weeks and then enter the ovulation cycle.
Category
Treatment - Drugs
2
Description
Control group: They receive folic acid powder 400 mg per day for 8 weeks and then enter the ovulation cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital Complex
Full name of responsible person
Firoozeh Akbari Asbagh
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
fasbagh_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Ali Akbari Sari
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
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
Firoozeh Akbari Asbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Fax
Email
fasbagh_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Firoozeh Akbari Asbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Fax
Email
fasbagh_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Firoozeh Akbari Asbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Fax
Email
fasbagh_md@yahoo.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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After the manuscript is 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. Firoozeh Akbari Asbagh, and any analysis must be done with her opinion.
From where data/document is obtainable
via email to fasbagh_md@yahoo.com
What processes are involved for a request to access data/document
Any request must be e-mailed with its proposal to Dr. Firoozeh Akbari Asbagh.