The comparison of the effectiveness of vitamin C supplementation with balance diet, versus Placebo on the Luteinizing hormone, follicle-stimulating hormone, Dehydroepiandrosterone, testosterone, estradiol, progesterone and sex hormone-binding protein in infertile women with polycystic ovary syndrome
This double-blind crossover randomized trial is a study foe measuring the effectiveness of vitamin c supplementation on several hormones levels in infertile women with a balanced diet. Inclusion Criteria: Having 2 of 3 criteria Rotterdam; Women with at least one year before entering the study had tried unsuccessfully to conceive; women aged 35-18 years and exclusion criteria: Unwillingness to continue working; sensitivity to vitamin c; abnormal bleeding .In this study, 56 infertile women with polycystic ovarian syndrome entered the study.The 56 women were divided into two groups of 28 And every menstrual cycle hormone test groups on day 3 (estradiol, Dehydroepiandrosterone, testosterone, sex hormone-binding protein, Luteinizing hormone, follicular hormone) and then one group received placebo and the other group vitamin C for one month, and then day 22 menstrual cycle is done progesterone test. Medication is discontinued and was done repeated on day 3 of menstruation hormone testing and control groups changed in the intervening months, the intervention group as in the control group.On 22 trial done, and the drug was discontinued in subsequent periods last 3 days of testing done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030312672N1
Registration date:2013-04-22, 1392/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-22, 1392/02/02
Registrant information
Name
Razeieh Hosseini
Name of organization / entity
The Ministry Of Health, Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 711235782
Email address
hoseiniraz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of vitamin C supplementation with balance diet, versus Placebo on the Luteinizing hormone, follicle-stimulating hormone, Dehydroepiandrosterone, testosterone, estradiol, progesterone and sex hormone-binding protein in infertile women with polycystic ovary syndrome
Public title
The effect vitamin C supplementation on infertile women with polycystic ovary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: People who are willing to cooperate؛ Having 2 of 3 criteria Rotterdam; Women with at least one year before entering the study had tried unsuccessfully to conceive; women aged 35-18 years; Do not use alcohol; Not used hormonal drugs within the last 2 months; No abnormal bleeding; Women who still have a normal uterus and tubal; Normal Spermogram man; Disorders related to reproductive hormones; no history of pelvic surgery; The absence of Laparoscopic Surgery; Body Mass Index between 19/8 to 29
exclusion criteria: Unwillingness to continue working; sensitivity to vitamin c; abnormal bleeding.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University Of Medical Of Research , Ministry of Health
Street address
Research Deputy, Shiraz University of Medical Science
City
Shiraz
Postal code
Approval date
2012-06-14, 1391/03/25
Ethics committee reference number
CT-91-6086
Health conditions studied
1
Description of health condition studied
Infertility, polycystic ovarian disease
ICD-10 code
N.97
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
LH
Timepoint
Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period
Method of measurement
ELIZA
2
Description
FSH
Timepoint
Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period
Method of measurement
ELIZA
3
Description
DHEAS
Timepoint
Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period
Method of measurement
ELIZA
4
Description
Testosterone
Timepoint
Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period
Method of measurement
ELIZA
5
Description
Estradiol
Timepoint
Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period
Method of measurement
ELIZA
6
Description
progesteone
Timepoint
Day 22 of first cycle, Day 22 of the second cycle
Method of measurement
ELIZA
7
Description
SHBG
Timepoint
Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period
Method of measurement
ELIZA
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in the early period of hormone tests performed and then 750 mg of vitamin C per day prescribed treatment period lasted up to 22 days and then tested progesterone medication is discontinued. In the next cycle day 3 hormonal tests done again, this time as the 22 day period will receive a placebo control group.
Category
Treatment - Drugs
2
Description
The control group in the early period of hormone tests performed and then placebo prescribed treatment period lasted up to 22 days and then tested progesterone medication is discontinued. In the next cycle day 3 hormonal tests done again, this time as the 22 day period will receive a 750 mg of vitamin C Intervention group .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Mother and Child Hospital (Ghadir)
Full name of responsible person
Razieh Hosseini
Street address
Quran Gate, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Razieh Hosseini
Street address
Zand Street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of Medical Sciences
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
Shiraz College Of Nursing Midwifery
Full name of responsible person
Sadigheh Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1242 4128
Fax
Email
Forouharism@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz College Of Nursing Midwifery
Full name of responsible person
Sadigheh Forouhari
Position
Master of Midwifery , Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1242 4128
Fax
Email
Forouharism@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz College Of Nursing Midwifery
Full name of responsible person
Sadighe Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1235 7282
Fax
+98 71 1230 7594
Email
Forouharism@yahoo.com
Web page address
www.Sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)