Determination of the effect of oral probiotic on sexual function in women with polycystic ovary syndrome treated with letrozole
Design
This study is a randomized clinical trial study that will be performed on 40 patients with polycystic ovary syndrome in the infertility clinic of Hormozgan University of Medical Sciences in 2020.
Settings and conduct
In the intervention group, one Lactofem capsule (including Lactobacillus acidophilus 109 ، 2, Bifidobacterium bifidus 109 ، 2, Lactobacillus rutri 2 × 109, Lactobacillus fermentum 109 × 2; capsule weight of 500 mg bio-capsule) was administered daily for one month orally. In the second month, letrozole at a dose of 2.5 mg daily from the third day of the menstrual cycle for 5 days with daily use of lactofem capsules for one month. In the control group, letrozole alone will be administered 2.5 days from the third day of the menstrual cycle for 5 days in the second month. The sexual function questionnaire will be completed before and two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 18-38 year, Definition of pcos based on the Rotterdam standard, Inability to conceive after one year of regular intercourse without the use of contraceptives, Absence of tubular factors, anatomical and male causes of infertility, Healthy uterine cavity, Normal levels of thyroid hormones.Exclusion criteria:Other endocrine disorders such as hyperprolactinemia, Unwillingness to participate in the study, Use metformin
Lack of follow-up
Intervention groups
Lactofem capsule (500 mg capsule) orally for two months with letrozole administration compared with letrozole alone
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N8
Registration date:2020-10-04, 1399/07/13
Registration timing:registered_while_recruiting
Last update:2020-10-04, 1399/07/13
Update count:0
Registration date
2020-10-04, 1399/07/13
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
2020-09-20, 1399/06/30
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral probiotic on sexual function in patients with polycystic ovary syndrome treated with letrozole
Public title
oral probiotic and sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-38 year
Definition of pcos based on the Rotterdam standard
Inability to conceive after one year of regular intercourse without the use of contraceptives
Absence of tubular factors, anatomical and male causes of infertility
Healthy uterine cavity
Normal levels of thyroid hormones
Exclusion criteria:
Other endocrine disorders such as hyperprolactinemia
Unwillingness to participate in the study
Use metformin
Lack of follow-up
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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 and B) for the allocation of subjects to intervention (A) and control (B) 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 Hormozgan University of Medical Sciences
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.HUMS.REC.1399.326
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention and two months after the intervention
Method of measurement
FSFI sexual function questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one Lactofem capsule (including Lactobacillus acidophilus 109 ، 2, Bifidobacterium bifidus 109 ، 2, Lactobacillus rutri 2 × 109, Lactobacillus fermentum 109 × 2; capsule weight of 500 mg bio-capsule) was administered daily for one month orally. In the second month, letrozole at a dose of 2.5 mg daily from the third day of the menstrual cycle for 5 days with daily use of lactofem capsules for one month.
Category
Treatment - Drugs
2
Description
Control group: letrozole alone will be administered 2.5 days from the third day of the menstrual cycle for 5 days in the second month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Street address
Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6365
Email
maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymoor Aghamolaei
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
معاونت پژوهشی دانشگا
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@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