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Evaluation of the effect of Lactofem probiotic supplement on sexual function in patients with different phenotypes of polycystic ovary syndrome undergoing cyproterone compound.

Protocol summary

Study aim
Evaluation of the effect of Lactofem probiotic supplement on sexual function in patients with different phenotypes of polycystic ovary syndrome undergoing cyproterone compound
Design
clinical trial with 8 intervention and control groups; with parallel groups; Randomized; Designed in 480 patients, phase 3, randomization using block method
Settings and conduct
Eligible patients referred to Muftah Clinic of Yasuj University of Medical Sciences will be divided into eight groups of 60 people according to phenotype and sexual function 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 groups (phenotype A, B, C, D): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Bio Fermentation Company, Iran) orally, daily, for 3 months) Control groups (phenotype A, B, C, D): cyproterone compound tablets (21 days per monthly cycle, for 3 months)
Main outcome variables
Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160524028038N18
Registration date: 2024-01-04, 1402/10/14
Registration timing: prospective

Last update: 2024-01-04, 1402/10/14
Update count: 0
Registration date
2024-01-04, 1402/10/14
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
2024-02-09, 1402/11/20
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Lactofem probiotic supplement on sexual function in patients with different phenotypes of polycystic ovary syndrome undergoing cyproterone compound.
Public title
Evaluation of the effect of Lactofem probiotic supplement on sexual function in patients with polycystic ovary syndrome
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 language or cognitive problems preventing the patient from completing the questionnaire No current use of drugs affecting sexual function No smoking Failure to previously diagnose an organic cause for sexual dysfunction by an experienced physician No current use of psychiatric medications 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: 480
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,a,B,b,C,c,D,d) for the allocation of subjects to intervention ( A, B, C, D)and control (a, b, c, d) 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
2023-12-20, 1402/09/29
Ethics committee reference number
IR.YUMS.REC.1402.149

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
FSFI sexual function questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: (phenotype A): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months)
Category
Treatment - Drugs

2

Description
Intervention group: (phenotype B): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months)
Category
Treatment - Drugs

3

Description
Intervention group: (phenotype C): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months)
Category
Treatment - Drugs

4

Description
Intervention group: (phenotype D): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months)
Category
Treatment - Drugs

5

Description
Control group (phenotype A): cyproterone compound tablets (21 days per monthly cycle, for 3 months)
Category
Treatment - Drugs

6

Description
Control group (phenotype B): cyproterone compound tablets (21 days per monthly cycle, for 3 months)
Category
Treatment - Drugs

7

Description
Control group (phenotype C): cyproterone compound tablets (21 days per monthly cycle, for 3 months)
Category
Treatment - Drugs

8

Description
Control group (phenotype D): cyproterone compound tablets (21 days per monthly cycle, for 3 months)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Zahra Asadi
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 917 793 1581
Email
zasadik66@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
Zahra Asadi
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
+98 917 793 1581
Email
zasadik66@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zahra Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 917 793 1581
Email
zasadik66@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zahra Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 917 793 1581
Email
zasadik66@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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