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Vitamin D Deficiency of Couples and Infertility

NCT ID: NCT03305510

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-06-01

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.

Conditions

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Vitamin D Deficiency Infertility Couples In-vitro Fertilization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Vitamin D deficiency

The level of vitamin D is below 20ng/ml.

vitamin D is below 20ng/ml

Intervention Type DIAGNOSTIC_TEST

Vitamin D insufficient

The level of vitamin D is between 20ng/ml and 30ng/ml.

No interventions assigned to this group

Vitamin D sufficient

The level of vitamin D is above 30ng/ml.

No interventions assigned to this group

Interventions

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vitamin D is below 20ng/ml

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Jiang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun Qian, Doctor

Role: STUDY_CHAIR

Tongji Hospital

References

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Jiang L, Yang J, Song J, Hu Y, Qian K. Normal fertilisation rates and serum 25-OHD levels among couples undergoing in-vitro fertilisation: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Jun 5;20(1):346. doi: 10.1186/s12884-020-02959-z.

Reference Type DERIVED
PMID: 32503520 (View on PubMed)

Other Identifiers

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Reproductive center of Tongji

Identifier Type: -

Identifier Source: org_study_id