Evaluating the effect of combination of Inofolic Supplement and Klomifen and Klomifen alone on infertility treatment in women with polycystic ovarian syndrome
Evaluating the effect of Inofolic Supplement to help infertility treatment in patients with polycystic ovarian syndrome
Design
Patients will be selected by simple random sampling method. Patients will be selected by researcher visiting the infertility clinic daily. After giving the necessary explanation about the study and signing the informed consent form, researcher will give a card to patients from a package containing 80 closed envelopes which contains cards A (intervention group) and B (control group). Patients will be divided into groups A (intervention group) and B (control group) based on the card they received. Sampling continues in two parallel groups until the number of samples completed. Patients have no information about grouping.
Settings and conduct
This clinical trial is carried out at the Infertility Clinic of Besat Hospital in Sanandaj. Patients are unaware of the group they are assigned and they will be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age of 20 to 40 years old, Infertile women with polycystic ovarian syndrome. Non inclusion Criteria: Ovarian surgery history in the past three months, Use of antiepileptic drugs and glucocorticoids
Congenital adrenal hyperplasia, Hypothyroidism, Hyperthyroidism
Intervention groups
Patients in the intervention group will be given clomiphene and inofolic supplement for 3 months and patients in the control group will receive only Clomiphene for 3 months.
Main outcome variables
The number of developed follicles,The number of clinical pregnancies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190825044605N1
Registration date:2019-09-27, 1398/07/05
Registration timing:retrospective
Last update:2019-09-27, 1398/07/05
Update count:0
Registration date
2019-09-27, 1398/07/05
Registrant information
Name
Khadijeh Ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 5890
Email address
k.ebrahimpour@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of combination of Inofolic Supplement and Klomifen and Klomifen alone on infertility treatment in women with polycystic ovarian syndrome
Public title
The effect of Inofolic Supplement on infertility treatment in women with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 20 to 40 years old
Infertile women with polycystic ovarian syndrome
Exclusion criteria:
Ovarian surgery history in the past three months
Use of antiepileptic drugs and glucocorticoids
Congenital adrenal hyperplasia
Hypothyroidism
Hyperthyroidism
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by simple random sampling method. Patients will be selected by researcher visiting the infertility clinic daily. After giving the necessary explanation about the study and signing the informed consent form, researcher will give a card to patients from a package containing 80 closed envelopes which contains cards A (intervention group) and B (control group). Patients will be divided into groups A (intervention group) and B (control group) based on the card they received. Sampling continues in two parallel groups until the number of samples completed. Patients have no information about grouping.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both intervention and control groups receive routine infertility treatment but they both are unaware of the group they are assigned and they will be kept blind about the drug type they will receive.
Placebo
Not 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
Kurdistan University of Medical Sciences, Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2019-01-02, 1397/10/12
Ethics committee reference number
IR.MUK.REC.1397.228
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
The number of developed follicles
Timepoint
Two weeks after the intervention
Method of measurement
Using Sonography
2
Description
The number of clinical pregnancies
Timepoint
Third week after intervention
Method of measurement
Based on Beta-HCG and ultrasound confirmation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will be given clomiphene and inofolic supplement for 3 months. In the first month of the intervention, 50 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month. In the second month of the intervention, 100 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month.In the third month of the intervention, 150 mg clomiphene is administered to the patient for 5 days from the third day of menstruation, an inofolic sachets containing 2000 g myoinositol and 200 μg folic acid is administered daily until the end of the month.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group received only clomiphene for 3 months. In the first month 50 mg clomiphene is administered to the patient for 5 days from the third day of menstruation. In the second month 100 mg clomiphene is administered to the patient for 5 days from the third day of menstruation.In the third month 150 mg clomiphene is administered to the patient for 5 days from the third day of menstruation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Khadijeh Ebrahimpour
Street address
Besat Hospital, Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
66186-34683
Phone
+98 87 3328 5910
Email
K.ebrahimpour@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
ebrahimghaderi@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
Khadijeh Ebrahimpour
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kurdistan University of Medical Sciences, Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
k.ebeahimpour@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Nasrin Soofizadeh
Position
Assistance Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Besat Hospital, Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3328 5910
Email
nsoofizadeh@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khadijeh Ebrahimpour
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kurdistan University of Medical Sciences, Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
k.ebrahimpour@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
Some part of the data on the primary outcome can be shared.
When the data will become available and for how long
One year after the publication of the paper 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. Khadijeh Ebrahimpouri, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: k.ebrahimpour@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 .