The purpose of this study is evaluation of the effects of chlosteriol on IVF outcomes in infertile women. For this purpose, first, of women reffering (attending) to Shiraz infertility clinics for IVF infertility, 180 ones will be selected. After assessing the study inclusion criteria and if satisfied, persons will be included in the study. Blood samples from 180 ones will be taken and vitamin D levels in the blood samples will be determined (measured). Among them, 90 ones that have vitamin D deficiency will be enrolled into the study. Four weeks prior to IVF, control and experimental group (intervention) will be fed by determined dose of placebo and cholestriol. The IVF outcomes in groups A and B, including pregnancy tests, and observation of pregnancy style eighth weeks after embryo transfer and the pregnancy continued until twentieth weeks of pregnancy will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030916911N1
Registration date:2014-08-05, 1393/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-05, 1393/05/14
Registrant information
Name
Bahar Morshed Behbahani
Name of organization / entity
Shiraz Medical University
Country
Iran (Islamic Republic of)
Phone
+98 71 1630 1288
Email address
morshed_b@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of calcitriol on IVF outcome in infertile women with vitamin D deficiency refers to infertility centers in Shiraz 2014-2015
Public title
Evaluation of calcitriol on IVF outcome in infertile women with vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Written consent; Lack of bone diseases (disorders); Lack of Kidney (renal) diseases; The absence of endocrine glands' disorders (abnormalities);Absence of chronic digestive disorders (Crohn's, colitis, ulcers, chronic diarrhea); Non-affliction to vitamin D and calcium metabolism disease that their specific effects have proven; Non-use of vitamin D and calcium supplements before entry into the study (oral use in two weeks ago and injection in the last six months); No use (Failure to use) drugs that have significant effects on serum levels of these compounds (vitamin D and calcium), such as antiepliletics (anticonvulsant), diuretics, cardiac drugs, blood pressure medications (drugs), cimetidine, theophilline, cholestyramine; Serum calcium level less than 10/5 g/dl
Exclusion criteria: Allergy to Vitamine D, vitamine D malabsorbtion syndrome, renal function disorder (abnormality), afflicted with hypercalcemia or vitamine D toxicity; Stop treatment (teraphy), ovulation stimulation or embryon transfer for any reseon; Afflicted with the disease affecting vitamine D level (renal diseases, endocrine system disorders); Afflicted with the disease affecting immenuty system; Use of drugs (medicine) affecting unction of immenuty system ; Exsposure to UV rays (radiation) subject to (with) medical and remedy (teraphy) purposes; Afflicted with acute diseases recently
Age
From 20 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
180
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
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz University of Medical Sciences Central Building, Zand Street
City
shiraz
Postal code
1978 -71345
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
ct-92-6899
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
n98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization
Primary outcomes
1
Description
vitamin d level in blood
Timepoint
before starting the process of IVF
Method of measurement
sampling
Secondary outcomes
empty
Intervention groups
1
Description
Drug Intervention group:Calcitriol tab 0.5microgram daily for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo administered to patients in this group for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother and Child Hospital Ghadir
Full name of responsible person
Mohamed Ibrahim Parsanezhad
Street address
Quran Gate,Mother and Child Hospital Ghadir
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences Central Building, Zand Street
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ms.Bahar Morshed Behbahani
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square
City
shiraz
Postal code
Phone
+98 71 1212 2633
Fax
+64 74252
Email
morshed_b@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ms.leila doryanizadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square
City
shiraz
Postal code
Phone
+98 910 700 3933
Fax
+64 74252
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)