Protocol summary
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Study aim
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The effect of vitamin D supplementation on pregnancy outcome in frozen thawed embryo transfer cycles
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Design
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In this randomized, not blinded , parallel, phase 2 clinical trial with control group, 114 women with vitamin d insufficiency were randomly divided into two groups using random number table.
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Settings and conduct
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Serum vitamin D level of patients who were candidate for frozen embryo transfer, was checked. 114 patients with serum vitamin D level less than 30 ng/ml and met the inclusion criteria were included in this study. Women were randomly divided into two groups. 57 patients, as a case group received 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 was normal, they entered in the frozen-thawed embryo transfer cycle. 57 another patients, as a control group entered in frozen-thawed embryo transfer cycles without any intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women who want transfer cryopreserved embryos, patients with serum vitamin D level less than 30 ng/ml
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 acquired uterine anomaly with or without operation; donation-recipient cycles .
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Intervention groups
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Intervention group: Patients, as a case group received 50000 units vitamin D supplement orally, weekly for 8-10 weeks and serum vitamin D level was rechecked in the end of treatment.
Control group: Women as a control group entered in frozen-thawed embryo transfer cycle without any intervention.
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Main outcome variables
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Chemical pregnancy
General information
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Reason for update
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Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201207156420N11
Registration date:
2013-12-24, 1392/10/03
Registration timing:
retrospective
Last update:
2021-04-19, 1400/01/30
Update count:
1
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Registration date
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2013-12-24, 1392/10/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Yazd reserch and clinical center for infertility
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Expected recruitment start date
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2013-09-01, 1392/06/10
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Expected recruitment end date
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2013-10-15, 1392/07/23
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Actual recruitment start date
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2013-09-01, 1392/06/10
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Actual recruitment end date
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2013-10-15, 1392/07/23
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Trial completion date
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2014-02-28, 1392/12/09
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Scientific title
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Effect of vitamin D deficiency treatment on pregnancy outcomes in frozen-thawed embryo transfer cycles
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Public title
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Treatment of vitamin D deficiency in assisted reproductive cycles.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women who were candidate for transfer cryopreserved embryos in ART cycles
Infertile women with serum vitamin D below 30ng/ml
Exclusion criteria:
Women older than 40 years
Women less than 20 years
BMI >30 Kg/m2
History of endocrine disorders
Severe endometriosis
Systemic diseases
Repeated implantation failure/repeated abortion
Congenital or acquired uterine anomaly with or without surgery
Women who had visible hydrosalpinx in vaginal ultrasonography
Cycles with egg or embryo donation
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
128
Actual sample size reached:
114
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this randomized clinical trial, infertile women with serum vitamin D below 30ng/ml were enrolled in the study. 1 to 114 numbers were assigned to each woman who met the inclusion criteria consecutively. After giving information about the research design and signed a written consent form, women divided into two 57-participant groups by using random number table and random codes generation. Randomization was simple, individual using a random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-09-23, 1392/07/01
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Ethics committee reference number
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214
Health conditions studied
1
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Description of health condition studied
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Vitamin D3 deficiency, Female infertility treatment
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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14 days after embryo transfer
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Method of measurement
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Serum B-hcg
Secondary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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28 days after embryo transfer
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Method of measurement
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Vaginal sonography
Intervention groups
1
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Description
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Control: Receiving no vitamin D supplementation.
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Category
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Treatment - Drugs
2
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Description
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Intervention: In case group, the patients received 50000 units vitamin D orally every week for 8-10 weeks before starting embryo transfer cycle.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd Research and Clinical Center for Infertility
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally in charge
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
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What processes are involved for a request to access data/document
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Submission of an official application via the agent that is legally in charge
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Comments
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