Vitamin D Deficiency of Couples and Infertility

Completed

• Conditions: Couples; Vitamin D Deficiency; Infertility; In-vitro Fertilization
• Interventions: Diagnostic Test: vitamin D is below 20ng/ml

• Registration Number: NCT03305510
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-06-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-08
• Study First Submitted QC: 2017-10-09
• Last Update Submitted: 2017-10-09
• Study First Posted: 2017-10-10
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamin D deficiency	vitamin D is below 20ng/ml	The level of vitamin D is below 20ng/ml.

Primary Outcome Measures

Name	Time	Method
fertilization rate	the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination	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.