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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03305510
Other study ID # Reproductive center of Tongji
Secondary ID
Status Completed
Phase N/A
First received October 8, 2017
Last updated October 9, 2017
Start date March 1, 2016
Est. completion date June 1, 2017

Study information

Verified date October 2017
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date June 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 42 Years
Eligibility 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


Intervention

Diagnostic Test:
vitamin D is below 20ng/ml


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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