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Completed

NCT Number: NCT03305510

Vitamin D Deficiency of Couples and Infertility

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 .

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Couples Deficiency Diseases Genital Diseases In-vitro Fertilization Infertility Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Urogenital Diseases

Age range

20 year–42 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vitamin D is below 20ng/ml

Diagnostic Test

Primary outcomes

  1. fertilization rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Prospective Cohort Study About Vitamin D Deficiency of Couples and Infertility

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2017
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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