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Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya (Other)
Overall Status
Completed
CT.gov ID
NCT03503006
Collaborator
(none)
2,569
Enrollment
1
Location
22.3
Actual Duration (Months)
115
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

At present, there is no agreement on the effect of vitamin D level in serum and follicular fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology. This project intends to make a prospective cohort study with large sample, based on a complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET pregnancy outcome. This study is also the first to study the relationship between maternal vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2569 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer
    Actual Study Start Date :
    Mar 21, 2018
    Actual Primary Completion Date :
    Oct 30, 2019
    Actual Study Completion Date :
    Jan 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. clinical pregnancy rate [Until 28 day after embryo transferred]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • female with only fallopian tube factor or male factor infertility,first IVF/ICSI cycle,18 years old≤age≤35 years old,take a long protocol or super-long protocol,18≤BMI≤25, menstrual regularity(periodic change < 7 days)
    Exclusion Criteria:
    • Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥2.0 cm, and/or Uterine fibroids located within the endometrium≤1cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan China 410008

    Sponsors and Collaborators

    • Reproductive & Genetic Hospital of CITIC-Xiangya

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reproductive & Genetic Hospital of CITIC-Xiangya
    ClinicalTrials.gov Identifier:
    NCT03503006
    Other Study ID Numbers:
    • LCYJ-201802
    First Posted:
    Apr 19, 2018
    Last Update Posted:
    Mar 23, 2020
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Mar 23, 2020