In respect of effects of vitD3 in implantation. In this clinical trial research we are going to evaluate effects of vit D3 ( Pregnancy outcome, clinical pregnancy rate)in patients with history of two or more repeated implantation failure. After excluding of other problems(Hormonal, Anatomical, Rheumatologic, Thrombophilia, genetic and male problems) and certain to no using vitamin D and Calcium from three months ago in patients, we have two groups: A)use tablet of Ca-D B.I.D twp months before ICSI(case group)n=50; B) use tablet of Ca B.I.D twp months before ICSI(control group)n=50.
General information
Acronym
Assisted reproductive technique
IRCT registration information
IRCT registration number:IRCT2012120311430N2
Registration date:2013-04-20, 1392/01/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Simin Zafardoust
Name of organization / entity
Jahad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 4701
Email address
s.zafardoost@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahad Daneshghahi
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the role of vitamin D3 in microinjection outcome in patients with repeated ART(Assisted Reproductive Technique) failure failure
Public title
The efficacy of vitD3 in patients with ART(Assisted Reproductive Teqchnique) failure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: infertile women 20-35 years old with two or more previous IVF failure, without using vitamin D and Calcium from 3 months before.
Exclusion criteria:untreated medical disorders; endometriosis; poor responders; hydrosalpinx in ultrasonography; abnormal semen analysis ( Abnormal form>96%,A+B≤32%); use of drugs that affect on immune system; thrombophilia (homozygot PAI-I , homozygot C677T, homozygot A1908C, Heterozygot A1908C-C977T); hormonal disorder (FSH>12,PCO); anatomic disorders; genetic disorders and infective disorders
Age
From 20 years old to 35 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
Jahad of university
Street address
Shariati-Yakhchal
City
Tehran
Postal code
19419113194
Approval date
2010-03-02, 1388/12/11
Ethics committee reference number
9224/ 51/ 30/ی پ
Health conditions studied
1
Description of health condition studied
Patients with IVF Failure
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
βhCG ,14 days after embryo transfer
2
Description
Abortion rate
Timepoint
every 2 months
Method of measurement
βhCG and ultrasonography
Secondary outcomes
1
Description
Quality of embryo
Timepoint
Embryo transfer
Method of measurement
Morfology
2
Description
1,25(OH)2D3
Timepoint
Before ovum pick up
Method of measurement
Blood sampling
Intervention groups
1
Description
Intervention group:Tablet Ca-D BID
Category
Treatment - Drugs
2
Description
Control Group:Tablet of Ca BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and recurrent pregnancy loss
Full name of responsible person
Dr Amir hasan Zarnani
Street address
Shariati-Yakhchal
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
َAvicenna research center
Full name of responsible person
Dr Akhondi Mohammad Mehdi
Street address
Yakhchal-Shariati
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
َAvicenna research center
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
Infertility and recurrent pregnancy loss center
Full name of responsible person
Dr Zafardoost Simin
Position
Obstetrics and Gynecologist-fellowship in infertility