Vitamin D Deficiency of Couples and Infertility

Study Overview
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Brief Summary
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Between March 2016 and March 2017, we performed a large retrospective, non-interventional, single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and reproductive capacity .

Detailed Description
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Before conducting ovarian stimulation, all couples must conduct preoperative routine examination such as routine blood test, blood group examination and infectious disease examination. We collected 2ml remaining blood from the examination by use of sodium heparin, which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry. All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.

Official Title
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Prospective Cohort Study About Vitamin D Deficiency of Couples and Infertility

Conditions
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Vitamin D Deficiency, Infertility, Couples, In-vitro Fertilization

Intervention / Treatment
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* Diagnostic Test: vitamin D is below 20ng/ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: couples who underwent IVF/ICSI. Exclusion Criteria: sperm or egg donation, PGD or PGS,TESA or PESA, ovum frozen ,no oocyte for fertilization.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitamin D deficiency<br>The level of vitamin D is below 20ng/ml. | Diagnostic Test: vitamin D is below 20ng/ml<br> <br> |
| Vitamin D insufficient<br>The level of vitamin D is between 20ng/ml and 30ng/ml. | |
| Vitamin D sufficient<br>The level of vitamin D is above 30ng/ml. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate | Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts. | the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination |