The treatment effect evaluation of vitamine D deficiency on fertility outcomes of patients who receive frozen-thawed embryos, is the aim of this study. This is a interventional, randomized, not blinded clinical trial. Serum vitamin D level of patients who want to transfer her own frozen embryos, is checked. 100 patients with serum vitamin D level less than 30 ng/ml are included in this study. The patients with sever endometriosis, systemic diseases and donated embryos, are excluded. 50 patients, as a case group receive 50000 units vitamin D supplement per oral, weekly for 8-10 weeks and serum vitamin D level is rechecked in the end of treatment. If serum vitamin D level is normal, they are intered in the frozen-thawed embryo transfer cycle. 50 another patients, as a control group are intered in frozen-thawed embryo transfer cycle without any intervention. Primary outcome is chemical pregnancy that is determind with serum B-hcg level 14 days after embryo transfer. secondry outcome is clinical pregnancy that is determind by seeing gestational sac in vaginal sonography, 28 days after embryo transfer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207156420N11
Registration date:2013-12-24, 1392/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-12-24, 1392/10/03
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd reserch and clinical center for infertility
Expected recruitment start date
2013-09-25, 1392/07/03
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D deficiency treatment on fertility outcomes in frozen-thawed embryo transfer cycles.
Public title
Treatment of vitamin D deficiency in assisted reproductive cycles.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women who want transfer cryopreserved embryos. Exclusion criteria: more than 40 years old; less than 20 years old ; history of endocrine disorder; severe endometriosis; systemic disease; repeated implantation failure; repeated abortion; congenital or aquired uterine anomally with or without operation; donation-recepient cycles .
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd research and clinical center for infertility
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
214
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
N97.9
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Serum B-hcg
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
28 days after embryo transfer
Method of measurement
vaginal sonography
Intervention groups
1
Description
Control: Recieve no vitamin D supplementation.
Category
N/A
2
Description
Intervention: In case group,the patients recieve 50000 units vitamin D per oral every week for 8-10 weeks before starting embryo transfer cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali Avenue, Safayeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Ali mohammad abdoli fahadan
Street address
Bouali Avenue, Safayeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd reaserch and clinical center for infertility
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
Yazd research center for infertility
Full name of responsible person
Abbas aflatoonian
Position
professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
Abbas_aflatoonian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd reserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd reserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)