Assessment of the effect of administration of hormonal contraceptives (OCP) with vitamin D3 supplements on the sexual dysfunction in women with polycystic ovary syndrome: A randomized double-blind placebo-controlled clinical triall
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
Due to content modification
Due to content modification
empty
به علت اصلاح مطالب
به علت اصلاح مطالب
Age 18-40 years old 2. Diagnosis of polycystic ovary syndrome based on Rotterdam criteria by gynecologist 3. Sexual dysfunction based on FSFI4 questionnaire. Lack of chronic diseases (diabetes, high blood pressure, previous venous embolism ...) 5. Women who have D3 vitamin D3 deficiency (D3 <20ng / ml .6) There is no evidence of depression based on the BDI7 questionnaire. Sexual activity during a recent month and sexually active. 8. Non-infertility based on patient's statements. 9. Condom use as a contraceptive method from the beginning of the study three months before the start of the study 10. Failure to plan for pregnancy during the study 11. No need for treatment for OCP 12. Rejection of other causes of ovulation and hyperandrogenemia (Cushing's disease, thyroid dysfunction, High levels of prolactin, congenital adrenal hyperplasia ...)
) Iranian women age 18- 404 years , 2) PCOS based on Rotterdam criteria (19), 3) women having Vitamin D3 level less than 20 ng/ml (base on the test), 4) women having sex in the last month, and 5) women who used non-hormonal contraceptives three months before the start of the study
Age) Iranian women age 18-40 404 years old, 2. Diagnosis of polycystic ovary syndrome) PCOS based on Rotterdam criteria by gynecologist(19), 3. Sexual dysfunction based on FSFI4 questionnaire. Lack of chronic diseases (diabetes, high blood pressure, previous venous embolism ...) 5. Women who havewomen having Vitamin D3 vitamin D3 deficiencylevel less than 20 ng/ml (D3 <20ng / ml .6) There is no evidence of depression basedbase on the BDI7 questionnaire. Sexual activity during a recenttest), 4) women having sex in the last month, and sexually active. 8. Non5) women who used non-infertility based on patient's statements. 9. Condom use as a contraceptive method from the beginning of the studyhormonal contraceptives three months before the start of the study 10. Failure to plan for pregnancy during the study 11. No need for treatment for OCP 12. Rejection of other causes of ovulation and hyperandrogenemia (Cushing's disease, thyroid dysfunction, High levels of prolactin, congenital adrenal hyperplasia ...)
1. سن 18-40 سال2. تشخیص سندرم تخمدان پلی کیستیک بر اساس معیار روتردام توسط متخصص زنان 3. وجود اختلال عملکرد جنسی بر اساس پرسشنامه FSFI4. عدم ابتلا به بیماریهای مزمن (دیابت، فشارخون بالا، آمبولی وریدی قبلی...)5. زنانی که براساس آزمایش ویتامینD3 مبتلا به کمبود ویتامینD3 می باشند( (D3<20ng/ml .6. عدم وجود شواهدی از افسردگی بر اساس پرسشنامه BDI7. داشتن فعالیت جنسی در یک ماه اخیر و فعال بودن از نظر جنسی8. عدم ناباروری براساس اظهارات بیمار 9. استفاده از کاندوم به عنوان روش پیشگیری از بارداری از سه ماه قبل از شروع مطالعه10. عدم قصد بارداری در طول مطالعه11. عدم نیاز درمانی به OCP 12. رد کردن علل دیگر عدم تخمک گذاری و هیپرآندروژنمی (بیماری کوشینگ، اختلال عملکرد تیروئید، سطح پرولاکتین بالا، هیپرپلازی مادرزادی آدرنال...)
1) زنان ایرانی 18 تا 44 ساله، 2) سندرم تخمدان پلی کیستیک بر اساس معیارهای روتردام (19)، 3) زنان دارای سطح ویتامین D3 کمتر از ng/ml 20 (بر اساس آزمایش)، 4) زنان دارای رابطه جنسی. در ماه گذشته و 5) زنانی که سه ماه قبل از شروع مطالعه از داروهای ضد بارداری غیر هورمونی استفاده کردند.
1. سن) زنان ایرانی 18-40 سال2. تشخیص تا 44 ساله، 2) سندرم تخمدان پلی کیستیک بر اساس معیارمعیارهای روتردام توسط متخصص(19)، 3) زنان 3. وجود اختلال عملکرد جنسی دارای سطح ویتامین D3 کمتر از ng/ml 20 (بر اساس پرسشنامه FSFI4. عدم ابتلا به بیماریهای مزمن (دیابتآزمایش)، فشارخون بالا، آمبولی وریدی قبلی...)54) زنان دارای رابطه جنسی. در ماه گذشته و 5) زنانی که براساس آزمایش ویتامینD3 مبتلا به کمبود ویتامینD3 می باشند( (D3<20ng/ml .6. عدم وجود شواهدی از افسردگی بر اساس پرسشنامه BDI7. داشتن فعالیت جنسی در یک ماه اخیر و فعال بودن از نظر جنسی8. عدم ناباروری براساس اظهارات بیمار 9. استفاده از کاندوم به عنوان روش پیشگیری از بارداری از سه ماه قبل از شروع مطالعه10. عدم قصدمطالعه از داروهای ضد بارداری در طول مطالعه11غیر هورمونی استفاده کردند. عدم نیاز درمانی به OCP 12. رد کردن علل دیگر عدم تخمک گذاری و هیپرآندروژنمی (بیماری کوشینگ، اختلال عملکرد تیروئید، سطح پرولاکتین بالا، هیپرپلازی مادرزادی آدرنال...)
included having the history of side effects (such as headache, vomiting from OCP), chronic diseases, including diabetes mellitus, hypertension, Vascular-Thrombi-Embolism (VTE), and thyroid, having the history for sterility, having no history of depression based on Beck Depression Inventory (BDI) questionnaire, having intention to conceive in near future, no need for OCP treatment, the having no history of Cushing's syndrome, adrenal hyperplasia, and adrenal tumor.
included having the history of side effects (such as headache, vomiting from OCP), chronic diseases, including diabetes mellitus, hypertension, Vascular-Thrombi-Embolism (VTE), and thyroid, having the history for sterility, having no history of depression based on Beck Depression Inventory (BDI) questionnaire, having intention to conceive in near future, no need for OCP treatment, the having no history of Cushing's syndrome, adrenal hyperplasia, and adrenal tumor.
داشتن سابقه عوارض جانبی (مانند سردرد، استفراغ ناشی از OCP)، بیماری های مزمن از جمله دیابت، فشار خون بالا، ترومبوز عروقی (VTE) و تیروئید، داشتن سابقه عقیمی، نداشتن سابقه افسردگی بر اساس پرسشنامه پرسشنامه افسردگی بک (BDI)، داشتن قصد باردار شدن در آینده نزدیک، عدم نیاز به درمان OCP، نداشتن سابقه سندرم کوشینگ، هیپرپلازی آدرنال و تومور آدرنال.
داشتن سابقه عوارض جانبی (مانند سردرد، استفراغ ناشی از OCP)، بیماری های مزمن از جمله دیابت، فشار خون بالا، ترومبوز عروقی (VTE) و تیروئید، داشتن سابقه عقیمی، نداشتن سابقه افسردگی بر اساس پرسشنامه پرسشنامه افسردگی بک (BDI)، داشتن قصد باردار شدن در آینده نزدیک، عدم نیاز به درمان OCP، نداشتن سابقه سندرم کوشینگ، هیپرپلازی آدرنال و تومور آدرنال.
This study is randomized using permuted block randomization contains 4th block (two participants in experimental group and two participants in placebo group) by the Random allocation software .
In case of vitamin D3 deficiency (less than 20 ng/ml) (20), all participants were randomly divided into two equal groups (A and B) using a random number table, where each selected number was randomly assigned to a group. became This work was done until the number of people in each group was completed. The researcher had no authority to change the status of the assignments or predict the entry of people into any group. Random concealment was performed by a third party who did not participate in the other phases of the intervention
This study is randomizedIn case of vitamin D3 deficiency (less than 20 ng/ml) (20), all participants were randomly divided into two equal groups (A and B) using permuted block randomization contains 4th block (two participantsa random number table, where each selected number was randomly assigned to a group. became This work was done until the number of people in experimentaleach group and two participantswas completed. The researcher had no authority to change the status of the assignments or predict the entry of people into any group. Random concealment was performed by a third party who did not participate in placebo group) bythe other phases of the Random allocation software .intervention
دراین مطالعه از روش تصادفی سازی بلوکی شامل بلوکهای 4 تایی(2 شرکت کننده در گروه مداخله و 2 شرکت کننده در گروه کنترل)با استفاده از نرم افزار تولید توالی تصادفی استفاده شده است
در صورت کمبود ویتامین D3 (کمتر از ng/ml 20) ، همه شرکت کنندگان به طور تصادفی به دو گروه مساوی (A و B) با جدول اعداد تصادفی تقسیم شدند که هر تعداد انتخاب شده به طور تصادفی به یک گروه تقسیم شدند. این کار تا تکمیل تعداد افراد هر گروه انجام می شد. محقق هیچ اختیاری برای تغییر وضعیت تکالیف یا پیش‌بینی ورود افراد به هیچ گروهی نداشت. اختفای تصادفی توسط شخص ثالثی انجام شد که در سایر مراحل مداخله شرکت نکرد.
دراین مطالعهدر صورت کمبود ویتامین D3 (کمتر از روشng/ml 20) ، همه شرکت کنندگان به طور تصادفی سازی بلوکی شامل بلوکهای 4 تایی(2به دو گروه مساوی (A و B) با جدول اعداد تصادفی تقسیم شدند که هر تعداد انتخاب شده به طور تصادفی به یک گروه تقسیم شدند. این کار تا تکمیل تعداد افراد هر گروه انجام می شد. محقق هیچ اختیاری برای تغییر وضعیت تکالیف یا پیش‌بینی ورود افراد به هیچ گروهی نداشت. اختفای تصادفی توسط شخص ثالثی انجام شد که در سایر مراحل مداخله شرکت کننده در گروه مداخله و 2 شرکت کننده در گروه کنترل)با استفاده از نرم افزار تولید توالی تصادفی استفاده شده استنکرد.
Recruitment centers
#1
Name of recruitment center - English: Emam hasan mojtaba hospital
Name of recruitment center - Persian: بیمارستان امام حسن مجتبی (ع)
Full name of responsible person - English: Raziyeh Navidmehr
Full name of responsible person - Persian: راضیه نویدمهر
Street address - English: Rajaee Street
Street address - Persian: خیابان رجایی
City - English: Nazarabad
City - Persian: نظراباد
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3331619755
Phone: +98 26 4535 5953
Fax:
Email: navidmehrraziyeh@gmail.com
Web page address:
Name of recruitment center - English: Emam Hasan Mojtaba Hospital
Name of recruitment center - Persian: بیمارستان امام حسن مجتبی (ع)
Full name of responsible person - English: Raziyeh Navidmehr
Full name of responsible person - Persian: راضیه نویدمهر
Street address - English: Emam Hasan Mojtaba Hospital., Beginning of Rajaee Ave
Street address - Persian: ابتدای خیابان رجایی، بیمارستان امام حسن مجتبی (ع)
City - English: Nazarabad
City - Persian: نظراباد
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3331619755
Phone: +98 26 4535 5953
Fax:
Email: navidmehrraziyeh@gmail.com
Web page address:
Name of recruitment center - English: Emam hasan mojtaba hospitalHasan Mojtaba Hospital Name of recruitment center - Persian: بیمارستان امام حسن مجتبی (ع) Full name of responsible person - English: Raziyeh Navidmehr Full name of responsible person - Persian: راضیه نویدمهر Street address - English: Emam Hasan Mojtaba Hospital., Beginning of Rajaee StreetAve Street address - Persian: ابتدای خیابان رجایی، بیمارستان امام حسن مجتبی (ع) City - English: Nazarabad City - Persian: نظراباد Province: Alborz Country: Iran (Islamic Republic of) Postal code: 3331619755 Phone: +98 26 4535 5953 Fax: Email: navidmehrraziyeh@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تربیت مدرس
Full name of responsible person - English: Mr. Seyyed Saeed Mousavian
Full name of responsible person - Persian: آقای سید سعید موسویان
Street address - English: Jalal Al Ahmad Highway ، Koui Nasr
Street address - Persian: بزرگراه جلال آل احمد-کوی نصر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411500111
Phone: +98 21 82880
Fax: +98 21 8800 4535
Email: pres@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه علوم پزشکی تربیت مدرس
Full name of responsible person - English: Mr., Seyyed Saeed Mousavian
Full name of responsible person - Persian: آقای سید سعید موسویان
Street address - English: Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave
Street address - Persian: خیابان جلال آل احمد، پل نصر، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411500111
Phone: +98 21 82880
Fax: +98 21 8800 4535
Email: pres@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares University Name of organization / entity - Persian: دانشگاه علوم پزشکی تربیت مدرس Full name of responsible person - English: Mr., Seyyed Saeed Mousavian Full name of responsible person - Persian: آقای سید سعید موسویان Street address - English: Jalal AlTarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Highway ، Koui NasrAve Street address - Persian: بزرگراهخیابان جلال آل احمد-کوی، پل نصر، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411500111 Phone: +98 21 82880 Fax: +98 21 8800 4535 Email: pres@modares.ac.ir Web page address:
Protocol summary
Study aim
Determination of the effect of concomitant administration of hormonal contraceptives (OCP) with vitamin D3 supplements on sexual dysfunction (MDD) in women with polycystic ovary syndrome.
Design
Considering that no study has been done on the subject of the research and the study has a 6 months’ follow-up, there is no possibility of doing a preliminary study prior to the main study. With 95% confidence and 90% test power, the number of samples in both groups equal to 31.08 which means 32 participants in each group, and with a 10% drop rate, 35 people participate in both groups with a total number of 70 participants.
Settings and conduct
First, 70 women aged 18-40 years old with PCOS, sexual dysfunction and vitamin D3 deficiency will be divided into two equal groups of experimental group and control group. Each group will receive 50,000 UI vitamin D3 pearl per week for up to 12 weeks. Patients in the intervention group will take contraceptive pills (OCP) for 3 months (21 days each month) along with vitamin D3 pearl, and those who are in the control group will take placebo with the exact same appearance and administration order of contraceptive pills for three months.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age: 18-40 years
Diagnosis of Polycystic Ovary Syndrome
Sexual dysfunction
Absence of chronic diseases
Women with vitamin D3 deficiency
Absence of depression
No infertility based on patient's statements
Using condom as a contraceptive method
Exclusion criteria
People who show side effects due to medication consumption
Intervention groups
People who are in the experimental group will receive contraceptives (OCP) for 3 months along with vitamin D3 Pearl.
Main outcome variables
Considering that vitamin D3 is likely to be useful in improving female sexual function, this study aims to investigate the synergistic effect of OCP with vitamin D3 pearls in women with PCOS.
General information
Reason for update
Due to content modification
Acronym
IRCT registration information
IRCT registration number:IRCT20150905023897N3
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2024-06-14, 1403/03/25
Update count:1
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
ِDr. Shahideh Jahanian Sadatmahalleh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4826
Email address
shahideh.jahanian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-04-18, 1398/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of administration of hormonal contraceptives (OCP) with vitamin D3 supplements on the sexual dysfunction in women with polycystic ovary syndrome: A randomized double-blind placebo-controlled clinical triall
Public title
Assessment of the effect of contraceptive pills on the treatment of sexual dysfunction in women with polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
) Iranian women age 18- 404 years , 2) PCOS based on Rotterdam criteria (19), 3) women having Vitamin D3 level less than 20 ng/ml (base on the test), 4) women having sex in the last month, and 5) women who used non-hormonal contraceptives three months before the start of the study
Exclusion criteria:
included having the history of side effects (such as headache, vomiting from OCP), chronic diseases, including diabetes mellitus, hypertension, Vascular-Thrombi-Embolism (VTE), and thyroid, having the history for sterility, having no history of depression based on Beck Depression Inventory (BDI) questionnaire, having intention to conceive in near future, no need for OCP treatment, the having no history of Cushing's syndrome, adrenal hyperplasia, and adrenal tumor.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In case of vitamin D3 deficiency (less than 20 ng/ml) (20), all participants were randomly divided into two equal groups (A and B) using a random number table, where each selected number was randomly assigned to a group. became This work was done until the number of people in each group was completed. The researcher had no authority to change the status of the assignments or predict the entry of people into any group. Random concealment was performed by a third party who did not participate in the other phases of the intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
the researcher and the patients will be unaware of how participants are treated and grouped. For this purpose, the OCP and placebo are codified by the scientific expert of the drug manufacturer (Iran Hormone Company). The main researcher treats patients double-blindly according to the codes of drug packets. The code of the drug packet is recorded on the form of individual information, and the researcher who tracks and completes the information form will not be aware of the type of treatment.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University of Medical Sciences
Street address
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.MODARES.REC.1397.169
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Sexual Dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Fanction Score obtained in the Female Sexual Function Index (FSFI) questionnaire
Timepoint
At the start of the study and 3 and 6 months from the start of the treatment
Method of measurement
Female Sexual Function Index (FSFI) questionnaire
2
Description
The level of vitamin D 3 in the blood
Timepoint
At the start of the study and 3 and 6 months from the start of the treatment
Method of measurement
Biochemical examination of blood
Secondary outcomes
empty
Intervention groups
1
Description
LD combined oral contraceptive pills produced by Iran Hormone company are consumed for 3 months, 21 days each month from the second day of the menstrual period, then the medication is not taken for 7 days, and then its consumption will start over again. Pills are taken for up to 3 menstrual periods.
Category
Treatment - Drugs
2
Description
Taking pills of the same color, shape and size (placebo) with LD, which completely has no effect, produced by Iran Hormone company for 3 months, 21 pills each month from the second day of menstruation, and then the medication is not taken for 7 days. Then its consumption start will start again. Pills are taken for up to 3 menstrual periods.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hasan Mojtaba Hospital
Full name of responsible person
Raziyeh Navidmehr
Street address
Emam Hasan Mojtaba Hospital., Beginning of Rajaee Ave
City
Nazarabad
Province
Alborz
Postal code
3331619755
Phone
+98 26 4535 5953
Email
navidmehrraziyeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mr., Seyyed Saeed Mousavian
Street address
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1411500111
Phone
+98 21 82880
Fax
+98 21 8800 4535
Email
pres@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
D Shahideh Jahanian Sadatmahale
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
D., Shahideh Jahanian Sadatmahale
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave.,
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
D Shahideh Jahanian Sadatmahale
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Title and more details about the data/document
Information on the main outcome of the study
When the data will become available and for how long
1400
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Use for further research in the future
From where data/document is obtainable
Email Addressing Responsible for Study
What processes are involved for a request to access data/document