NCT03305510

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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

October 8, 2017

Last Update Submit

October 9, 2017

Conditions

Outcome Measures

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.

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

Study Arms (3)

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

Vitamin D deficiency

Eligibility Criteria

Age20 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • couples who underwent IVF/ICSI.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vitamin D DeficiencyInfertility

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Kun Qian, Doctor

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 8, 2017

First Posted

October 10, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10