Evaluation of the effect of myoinositol on the sexual function of patients with polycystic ovary syndrome treated with cyproterone compound
Design
clinical trial with a control group; with parallel groups; Randomized; Designed in 60 patients; phase 3; randomized using block randomization method
Settings and conduct
Eligible patients referred to Mofateh Clinic of Yasuj University of Medical Sciences will be divided into four groups of 30 people and sexual performance will be measured.
Participants/Inclusion and exclusion criteria
Eligibility conditions: age 18 to 40 years, Confirmation of polycystic ovary syndrome based on the Rotterdam criteria, Iranian, Absence of severe mental conditions since six months before the research, Not suffering from severe depression and anxiety according to the depression and anxiety questionnaire, No current use of psychiatric medications, No language or cognitive problems preventing the patient from completing the questionnaire, No smoking, No current use of drugs affecting sexual function, Failure to previously diagnose an organic cause for sexual dysfunction by an experienced physician, Currently taking cyproterone compound tablets as prescribed by the gynecologist
Intervention groups
Intervention group : inofolic powder (2 grams myoinositol + 400 micrograms folic acid; daily,12 weeks) along with cyproterone compound tablet (21 days per monthly cycle, 3 months); control group: Cyproterone compound tablet (21 days per monthly cycle, 3 months)
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N17
Registration date:2023-07-03, 1402/04/12
Registration timing:prospective
Last update:2023-07-03, 1402/04/12
Update count:0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-08, 1402/04/17
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of myoinositol on the sexual function of patients with polycystic ovary syndrome treated with cyproterone compound
Public title
myoinositol and sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 to 40 years
Confirmation of polycystic ovary syndrome based on the Rotterdam criteria
Iranian
Absence of severe mental conditions since six months before the research
Not suffering from severe depression and anxiety according to the depression and anxiety questionnaire
No current use of psychiatric medications
No language or cognitive problems preventing the patient from completing the questionnaire
No smoking
No current use of drugs affecting sexual function
Failure to previously diagnose an organic cause for sexual dysfunction by an experienced physician
Currently taking cyproterone compound tablets as prescribed by the gynecologist
Exclusion criteria:
Patients who do not want to cooperate.
Pregnancy during study
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A، B ) for the allocation of subjects to intervention and control groups will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.YUMS.REC.1402.050
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
Sexual function
Timepoint
Before the intervention and three after the intervention
Method of measurement
sexual function questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: inofolic powder (2 grams myoinositol + 400 micrograms folic acid; daily,12 weeks) along with cyproterone compound tablet (21 days per monthly cycle, 3 months)
Category
Treatment - Drugs
2
Description
Control group: Cyproterone compound tablet (21 days per monthly cycle, 3 months)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of medical sciences, Shahid Mofateh Clinic
Full name of responsible person
Parvin-Alsadat Eslamnik
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 912 425 8623
Email
f.bazarganipour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
amin.hosseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Parvin-Alsadat Eslamnik
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
f.bazarganipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin-Alsadat Eslamnik
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
f.bazarganipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin- Alsadat Eslamnik
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
f.bazarganipour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD