Assessing the effect of adding vitamin D and vitamin E to metformin with dydrogesterone regimen؛ in the treatment of infertile women with polycystic ovary syndrome
The aim of this study is assessing the effect of vitamin E and vitamin D in metformin with dydrogesterone regimen in the treatment of infertile women with polycystic ovary syndrome (PCOS). This assessing is done by studying menstrual discipline؛ follicle maturation؛ endometrial thickness and the pregnancy occurrence in infertile women with PCOS. PCOS patients are identified by Rotterdam criteria and are randomly divided into two groups.
In one group vitamin D and in the other group vitamin E level will be measured. Patients will be divided again in to 4 categories based on vitamin E and vitamin D level(vitamin D deficient , vitamin D sufficient, vitamin E deficient, vitamin E sufficient). These four groups will be divided into two groups as case and control. Metformin with dydrogesterone regimen will be considered as the basement of therapy in all groups. Vitamin D will be added to the cases of the first group and vitamin E will be added to the cases of the second one as adjuvant therapy. Patients will take drugs for three months and the conclusion will be done on the base of the additive effect of therapy؛ assessing changes in the menstrual state؛ the sonographic evaluation؛ success in pregnancy and weight changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022821653N5
Registration date:2016-10-25, 1395/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-25, 1395/08/04
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Science
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of adding vitamin D and vitamin E to metformin with dydrogesterone regimen؛ in the treatment of infertile women with polycystic ovary syndrome
Public title
The influence of vitamin D and vitamin E in the treatment of infertile women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria؛ Infertile women with polycystic ovary syndrome (PCOS)؛ which had no pregnancy history after 12 months of unprotected intercourse.
Exclusion criteria؛ Women with other causes of infertility such as endometriosis؛ internal and surgical diseases؛ and patients who do not have polycystic ovary syndrome (PCOS) criteria.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
317
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers for choosing patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jahrom University of Medical Sience
Street address
Jahrom University of Medical Sience. Motahari boulevard
City
Jahrom
Postal code
Approval date
2016-02-05, 1394/11/16
Ethics committee reference number
IR.JUMS.REC.1394.177
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovary syndrome
Primary outcomes
1
Description
Follicle size
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Sonography
2
Description
Endometrial thickness
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Sonography
3
Description
Menstural discipline
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Sonography
4
Description
Pregnancy
Timepoint
Before intervention and 3 months after intervention
Method of measurement
BHCG
5
Description
Weight
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 3: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.tablet vitamin E 400mg from Dana pharmaceuticals one tablet daily for three months.
control group 3: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.
Category
Treatment - Drugs
2
Description
intervention group 2: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstural cycle to the twenty fifth day of it for three months. capsule vitamin D1000IU from Zahravy pharmaceuticals one capsule daily for three months.
control group 2: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstural cycle to the twenty fifth day of it for three months.
Category
Treatment - Drugs
3
Description
intervention group 1: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months. capsule vitamin D1000IU from Zahravy pharmaceuticals one capsule daily for three months.
control group 1: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.
Category
Treatment - Drugs
4
Description
intervention group4: metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.tablet vitamin E 400mg from Dana pharmaceuticals one tablet daily for three months.
control group 4: only metformin 500mg by Shafa pharmaceuticals؛ one tablet daily for the first week؛ two tablets daily for the second week and then three tablets daily from the third week to the rest of therapy for three months. tablet Dydrogesterone 10mg by solvay pharmaceuticals one tablet daily from the fifteenth day of menstrual cycle to the twenty fifth day of it for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Rasekh Jahromi Infertility Clinic
Full name of responsible person
Athar Rasekh Jahromi
Street address
22 Bahman Avenue
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of jahrom university of medical sience
Full name of responsible person
Dr Kavous Solhjo
Street address
Jahrom University of Medical Sience, Motahari boulevard
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of jahrom university of medical sience
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sience
Full name of responsible person
Dr Kavous Solhjo
Position
Phd of microbiology, Vice Chancellor for research of jahrom university od medical sience
Other areas of specialty/work
Street address
Jahrom University of Medical Sience, Motahari boulevard
City
Jahrom
Postal code
Phone
+98 71 5444 0821
Fax
Email
sohjo@jums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sience
Full name of responsible person
Fatemeh Kargarfard
Position
medical student
Other areas of specialty/work
Street address
Alley 5. Fard asadi avenue
City
Jahrom
Postal code
7416653134
Phone
+7 1330990
Fax
+98 71330990
Email
fatemehkargarfard@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sience
Full name of responsible person
Fatemeh Kargarfard
Position
medical student
Other areas of specialty/work
Street address
Alley5. Fard asadi avenue. Jahrom
City
Jahrom
Postal code
7416653134
Phone
+7 1330990
Fax
+98 71330990
Email
fatemehkargarfard@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)