Evaluation of the effect of supplementation with vitamin E and vitamin D on serum and follicular fluid oxidative and anti oxidative stress factors, oocyte quality and ICSI outcomes in PCOS infertile women candidate for ICSI who referred to Infertility Clinic of Avicenna Research Center during 2014-2015
The aim of this study is to assess the effects of vit E, vit D on serum and follicular fluid MDA, TAC, SOD and oocyte quality and ICSI out comes in infertile pcos women. For this purpose we enroll 100 infertile pcos women who need ICSI in avicenna infertility clinic during 2014-2015.they divide randomly in two groups.group1 receive 400IU vit E per day and 50000 IU vit D biweekly for 2 months and group 2 receive placebo for 2 months.both groups receive nutrition consult and they receive controlled low glycemic diet with balanced antioxidants and reduced trans fat.ICSI protocol is long in all patients. MDA, TAC, SOD are measured in serum twice: at the beginning of the study, before intervention and at the oocyte collection day and in follicular fluid on the oocyte collection day.antioxidant therapy seem to improve oocyte quality and ICSI outcomes due to reduce oxidative stress markers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081018662N1
Registration date:2014-08-21, 1393/05/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-21, 1393/05/30
Registrant information
Name
Farnaz Fatemi
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
f.fatemi@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility Clinic
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of supplementation with vitamin E and vitamin D on serum and follicular fluid oxidative and anti oxidative stress factors, oocyte quality and ICSI outcomes in PCOS infertile women candidate for ICSI who referred to Infertility Clinic of Avicenna Research Center during 2014-2015
Public title
Effect of vitamin E, vitamin D on treatment of infertility in PCOS patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: PCOS patients based on ROTERDOM criteria; age:18-38 years old; day3 FSH level less than 12; BMI:20-34.
Exclusion criteria: patients with heart, liver or renal disease; patients with Endometriosis; use of anticoagulats: ASA, Heparin, Warfarin; use of antidepresants:Fluoxetin, Certeralin; use of Statins: Levastatin, Atorvastatin; patients with Eye disease: Retinitis pigmentosa; use of anti inflammatory drugs and corticosteroids:prednisolon; use of vitamins and anti oxidants in 3 months ago; vit K deficiency and bleeding disorders; history of chemotherapy or radiotherapy
Age
From 18 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute Ethics Committee
Street address
Avicenna Research Institute, Shahid Beheshti University, Velenjak Avenue, Chamran highway