Investigating the effect of jujube hydroalcoholic extract on the pregnancy outcomes of infertile polycystic ovary syndrome patients s undergoing ovulation induction and comparing it with myoinositol and metformin.
To determine the effect of jujube hydroalcoholic extract on the pregnancy outcome of polycystic ovary syndrome patients undergoing ovulation induction.
Design
Double-blind randomized clinical trial
Settings and conduct
This clinical trial will be conducted in Imam Reza Hospital (AS) Mashhad (Milad Infertility Center) and infertility clinics in Mashhad city. Polycystic ovary and infertility patients who, according to the infertility specialist, should undergo ovulation induction with letrozole, are placed in the metformin, myinositol, jujube and placebo group for 12 weeks as a pre-treatment. Clinical and biochemical fertility results will be reported and compared after this period and the use of letrozole by all patients. Anthropometric indicators, lipid profile, sugar profile and clinical symptoms of polycystic ovary patients will be investigated at the beginning and end of the intervention.
Participants/Inclusion and exclusion criteria
Women with PCOS according to the Rotterdam criteria in the age range of 18-45 years
Willingness to cooperate in the project
Trying to get pregnant for more than a year
- No history of liver and kidney disease
No other metabolic diseases
- No history of hyperprolactinemia, Cushing's, hypothyroidism, congenital adrenal hyperplasia
- Absence of various allergies
- Not using contraceptive and hormonal pills during the 3 months before the study
Intervention groups
Patients with polycystic ovary syndrome and infertility
Main outcome variables
biochemical pregnancy
clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230712058752N1
Registration date:2023-07-18, 1402/04/27
Registration timing:registered_while_recruiting
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
Faezeh Mashhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 6274
Email address
mashhadif4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-12, 1402/04/21
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of jujube hydroalcoholic extract on the pregnancy outcomes of infertile polycystic ovary syndrome patients s undergoing ovulation induction and comparing it with myoinositol and metformin.
Public title
Investigating the effect of jujube hydroalcoholic extract on the pregnancy outcomes of infertile polycystic ovary syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with PCOS according to the Rotterdam criteria
age range between18-45 years
Willing to cooperate in the study
Trying to get pregnant for more than a year
No history of liver and kidney disease
No other metabolic diseases
No history of hyperprolactinemia, Cushing's, hypothyroidism, congenital adrenal hyperplasia
Absence of various allergies
Not using contraceptive and hormonal pills during the 3 months before the study
Exclusion criteria:
other metabolic disease
thyroid disorders
OCP and hormonal drugs before intervention
history of allergy
history of cancer
alcohol or drugs abuse
infertility due to disease another than PCOS
Age
From 18 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
196
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done using Sealedenvelope.com website. Blocks of 4 or 8 will be used to create a random sequence in the present study
Blinding (investigator's opinion)
Double blinded
Blinding description
In the groups receiving tablets, sachets and in the groups receiving sachets, placebo tablets will be used
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad Medical University of Medical Sciences, faculty of medicine
Street address
Mashhad, 91778 99191Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.191
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
biochemical pregnancy
Timepoint
after intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
change in PCOS morphology in sonography
Timepoint
after intervention
Method of measurement
ultrasound sonography
Intervention groups
1
Description
the first Intervention group:: Jujube, in the form of jujube hydroalcoholic extract in the amount of one 10 gram sachet per day, dissolved in 100 cc of cooled boiled water and consumed by patients for 12 weeks. This sachet is prepared from jujube hydroalcoholic extract in Mashhad Faculty of Medicine, Department of Pharmacology
Category
Treatment - Drugs
2
Description
the second intervention group: Metformin, taking one Glucophage 500 mg metformin tablet after lunch for 12 weeks
Category
Treatment - Drugs
3
Description
the third intervention group: Myoinositol, in the form of one inofolic sachet daily for 12 weeks
Category
Treatment - Drugs
4
Description
Control group: Placebo, in tablet form in the sachet receiving groups, and in sachet form in the pill receiving groups, one daily for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
milad infertility treatmaent center Imam Reza Hospital Mashhad
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Mashhadi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Park square, mashhad university of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
mashhadif4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Mashhadi
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
park square, mashhad university of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
mashhadif4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Mashhadi
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
park square, Mashhad university of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
mashhadif4001@mums.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
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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data related to blood tests and demographic factors of people will be published in the article after the study
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers and people who are engaged in the pharmaceutical industry and market
Under which criteria data/document could be used
To investigate treatments that help to treat infertility
From where data/document is obtainable
Faezeh Mashhadi
MD.PhD of nutrition science
mashhadif4001@mums.ac.ir
What processes are involved for a request to access data/document
The reason for the need to send the data and the design proposal
After review by the research team of the article and obtaining permission from them, the data will be available to the researcher