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Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

Sponsor
ART Fertility Clinics LLC (Other)
Overall Status
Completed
CT.gov ID
NCT03073720
Collaborator
(none)
43
Enrollment
1
Location
29.2
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the correlation between bioavailable Vitamin D values and euploid status of the embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To study the possible correlation between bioavailable vitamin D values in follicular fluid and embryo quality markers.

    To correlate bioavailable Vitamin D values in follicular fluid from large size follicles with embryo euploid status as our main objective. Secondly, looking at morphokinetics and mitochondrial content of these embryos.

    Taking into account that most of UAE patients have deficiency or insufficiency of Vitamin D, if there is a correlation found we will understand better the underlying mechanism by which bioavailable Vitamin D levels may be affecting embryo quality, therefore IVF outcomes.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Follicular Fluid Levels of Bioavailable Vitamin D and Embryo Quality Markers: Euploid Status, Morphokinetics and Mitochondrial DNA Content Among UAE Women Undergoing an IVF Cycle
    Actual Study Start Date :
    Jul 26, 2017
    Actual Primary Completion Date :
    Jul 30, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Vitamin D values in follicular fluid and embryo quality markers among UAE women undergoing an IVF cycle [6-10 months]

      A correlation between vitamin D levels and embryo development patterns

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 48 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Women´s Age >18 - ≤43 years.

    • BMI 19-33

    • Male partner will produce fresh sperm sample on the same day of the egg collection procedure.

    • Women with more than 10 follicles at the time of the trigger

    • At the time of egg retrieval, at least three follicles between 14-<17 mm and three follicles ≥17 mm.

    • Women ≤35 years old stimulation with rFSH antagonist

    • Women ≥36 years old stimulation with highly-purified human menopausal gonadotropins (hpHMG) specifically for the additional LH.

    • Middle East population

    Exclusion Criteria:

    • Polycystic ovarian syndrome (according to the Rotterdam Criteria).

    • Patients at risk of OHSS, according to the criteria previously described by Papanikolau et al. (23).

    • History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.

    • Severe male factor definition (<2 million of sperm per ml of ejaculate)

    • Recurrent miscarriage (3 miscarriages)

    • Smokers

    • History of chemotherapy or radiotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVI Middle East Fertilty Clinic Abu Dhabi United Arab Emirates

    Sponsors and Collaborators

    • ART Fertility Clinics LLC

    Investigators

    • Principal Investigator: Human Fatemi, Medical D., ART Fertility Clinics LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof Dr. Human Fatemi, Medical Director, ART Fertility Clinics LLC
    ClinicalTrials.gov Identifier:
    NCT03073720
    Other Study ID Numbers:
    • 1606-ABU-048-HF
    First Posted:
    Mar 8, 2017
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Mar 6, 2020