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CompletedNCT03305510Updated Oct 10, 2017

Vitamin D Deficiency of Couples and Infertility

An observational study in Vitamin D Deficiency, Infertility and Couples, sponsored by Tongji Hospital. Completed. Open to participants aged 20 Years to 42 Years. Per ClinicalTrials.gov, last updated 2017-10-10.

Sponsored by Tongji Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
20 Years to 42 Years
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Vitamin D Deficiency
  • Infertility
  • Couples
  • In-vitro Fertilization
03

Who can participate

Ages eligible
20 Years to 42 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

non-interventional, single-center cohort study and measured 25(OH) D plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.

Inclusion criteria

  • couples who underwent IVF/ICSI.

Exclusion criteria

Exclusion Criteria:

  • sperm or egg donation, PGD or PGS,TESA or PESA, ovum frozen ,no oocyte for fertilization.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (actual)
Patient registry
No

Groups and cohorts

  • Vitamin D deficiency

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

    Diagnostic Test: vitamin D is below 20ng/ml

  • Vitamin D insufficient

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

  • Vitamin D sufficient

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

Interventions

  • Diagnostic testvitamin D is below 20ng/ml
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 32503520 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03305510
Lead sponsor
Tongji Hospital
Responsible party
Liu Jiang (MD, Tongji Hospital) — Principal investigator
First posted
Oct 10, 2017
Start date
Mar 1, 2016
Primary completion
Mar 1, 2017
Completion
Jun 1, 2017
Last update
Oct 10, 2017

Study contacts

Kun Qian, Doctor
study chair · Tongji Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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