Determining the effect of sildenafil along with melatonin on oxidative stress markers in patients with polycystic ovary syndrome treated with metformin.
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized and phase 3 study on 128 patients. These patients are randomly divided into 4 groups with a ratio of 1.1 using the random generation computer method, and after receiving the code of ethics and obtaining informed consent, they are entered into the study.
Settings and conduct
Patients with polycystic ovary syndrome referred to Shahid Mofateh Yasouj Clinic are randomly divided into four groups (one control group and three intervention groups) using the random allocation method. The total time of the intervention is 3 months and blood samples are taken at the beginning and end of the intervention. It should be noted that the patient and the researcher did not know about the allocation of the groups and the study is double blind.
Participants/Inclusion and exclusion criteria
Inclusion:
1: age 18 to 45 years 2: body mass index 19 to 25 3: presence of two of the following: findings of ultrasound, signs of hyperandrogenism: clinical, laboratory, oligomenorrhea or amenorrhea
Exclusion:
1: unwillingness to cooperate 2: sensitivity to sildenafil and intolerance of side effects 3: pregnancy 4: severe mental conditions 5: suffering from severe depression and anxiety 6: Current use of psychiatric drugs 7: Smoking
Malonodialdehyde,Metabolites of Nitric oxide,protein metabolites carbonyl,total thiol,total antioxidant,capacity,Reactive protein C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230427058010N1
Registration date:2024-03-11, 1402/12/21
Registration timing:prospective
Last update:2024-03-11, 1402/12/21
Update count:0
Registration date
2024-03-11, 1402/12/21
Registrant information
Name
Mohammad Farajniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3325 3739
Email address
mohammadfarajniya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-18, 1402/12/28
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 sildenafil plus melatonin on oxidative stress markers in polycystic ovarian syndrome patients who treated with metformin
Public title
Evaluation of the effect of sildenafil plus melatonin on oxidative stress markers in polycystic ovarian syndrome patients who treated with metformin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 45 years
Body mass index 19 to 25
Presence of two of the following cases (according to the Rotterdam criteria): Findings of ultrasound sonography ,which was performed on the 10th day of the patient's last menstrual cycle (ovarian volume more than 10 ml or more than 12 follicles of 2 to 9 mm)
Symptoms of hyperandrogenism: Clinical (hirsutism according to Freeman Galloway criteria more than 7 or acne) ,Laboratory (increasing the total testosterone level more than the standard value determined by the relevant laboratory) Oligomenorrhea (cycles longer than 35 days) or amenorrhea (absence of menstruation in the last 6 months)
Exclusion criteria:
Patients who do not want to cooperate.
Sildenafil sensitivity and intolerance to side effects (flushing, visual disturbances, severe drop in blood pressure and hearing disorders)
Pregnancy
Existence of severe mental conditions since 6 months before the research that has an adverse effect on the patient's quality of life, such as the death of a loved one, incurable illness in family members, change of residence, sudden loss of job or extensive surgery.
Suffering from a severe degree of depression and anxiety according to the depression and anxiety questionnaire based on the Beck depression and anxiety questionnaire
Current use of psychiatric medications
Language or cognitive problems preventing the patient from completing the questionnaire
Smoking
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
The block method will be used to assign people to the studied groups. The advantages of block randomization are that the balance of the number of patients in each group is guaranteed. Groups are defined as codes D, C, B, A. Before assigning people to one of the groups, a list of these letters (A, B, C, D) is formed in the form of blocks. Each of the referring and qualified people is assigned to one of the groups. To avoid the predictable risk of assigning people to different groups, blocks with different sizes (4,8,16) will be created.
Blocks are created by the reliable website https://www.sealedenvelope.com and each of the eligible applicants will be assigned to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, none of the participants, clinical caregiver (physician), researchers and outcome evaluator know about the allocation of study groups. This is when all participants have approved and signed the informed consent form to participate in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Yasouj, Shahid Motahari Blvd., Central Headquarters of Yasouj University of Medical Sciences
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.YUMS.REC.1401.195
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
Total plasma antioxidant capacity
Timepoint
0-3 months
Method of measurement
Ferric Reducing Ability of Plasma
2
Description
Metabolites NO
Timepoint
0-3 months
Method of measurement
Griess method
3
Description
Sulfidril protein
Timepoint
0-3 months
Method of measurement
spectroscopy
4
Description
Protein carbonyl
Timepoint
0-3 months
Method of measurement
spectroscopy
5
Description
Malonodialdehyde (MDA)
Timepoint
0-3 months
Method of measurement
spectroscopy
6
Description
The inflammatory marker CRP
Timepoint
0-3 months
Method of measurement
Eliza Sandwich
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: sildenafil (25 mg sildenafil citrate orally every 6 hours) + metformin tablets (500 mg three times a day orally)
Category
Treatment - Other
2
Description
second intervention group: melatonin (3 mg melatonin tablets daily (Razak Pharmaceutical Company, Iran) + Metformin tablet (500 mg orally three times a day)
Category
Treatment - Other
3
Description
third intervention group: melatonin (3 mg melatonin tablet daily, Razak Pharmaceutical Company, Iran) + sildenafil (25 mg sildenafil citrate orally every 6 hours) + metformin tablet (500 mg) gram three times a day orally)
Category
Treatment - Other
4
Description
fourth intervention group: metformin tablets (500 mg orally three times a day)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofteh Yasouj Clinic
Full name of responsible person
Zahra Asadi kalmeh
Street address
15 Gholestan
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 9101 3813
Email
info@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Emam Sajad Yasouj Hospital
Full name of responsible person
Zahra Asadi kalmeh
Street address
Kohgiloyeh and Boyerahmad, Yasouj, next to Azadi Hotel
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 0165
Email
info@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Emam Sajad Yasouj Hospital
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Emam Sajad Yasouj Hospital
Full name of responsible person
Zahra Asadi kalmeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kohgiloyeh and Boyerahmad, Yasouj, next to Azadi Hotel
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 0165
Email
Zasadik66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Sajad Yasouj Hospital
Full name of responsible person
Zahra Asadi kalmeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kohgiloyeh and Boyerahmad, Yasouj, next to Azadi Hotel
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 0165
Email
Zasadik66@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Farajniya
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Ghadir Ave, Faniva Herfei Str, Sarabtaveh
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591147968
Phone
+98 74 3325 3739
Email
mohammadfarajniya@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
No decision has been made yet
When the data will become available and for how long
No decision has been made yet
To whom data/document is available
No decision has been made yet
Under which criteria data/document could be used
No decision has been made yet
From where data/document is obtainable
No decision has been made yet
What processes are involved for a request to access data/document