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Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters

Sponsor
Bahceci Clinic (Other)
Overall Status
Unknown status
CT.gov ID
NCT02365337
Collaborator
(none)
100
Enrollment
1
Location
15
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is observing the relation between serum Vitamin D levels and morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as normal or low , and the influence of those levels in morphokinetic parameters of embryos will be identified.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Up to date there are few studies questioning the serum Vitamin D deficiency as a negative factor for pregnancy rates in women undergoing COH cycles and also are displaying different and inconclusive results. This dedicated negative affects may be mediated through endometrial and/or ovarial factors. In experimental animal models Vitamin D receptors have been found in endometrium and ovaries and deficient levels might have been a cause of impaired folliculogenesis. In one of human study Vitamin D has been suggested as a positive regulator of anti- Mullerian hormone (AMH) production. Therefore, we aimed to clarify the affects of Vitamin D on folliculogenesis, oogenesis and embryo quality in COH cycles by using time lapse monitoring.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters in Women Undergoing Controlled Ovarian Hyperstimulation
    Study Start Date :
    Apr 1, 2015
    Anticipated Primary Completion Date :
    Jun 1, 2016
    Anticipated Study Completion Date :
    Jul 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    vitamin D levels < 20ng/ ml

    Vitamin D levels < 20ng/ ml
    vitamin D levels>20ng/ ml

    Vitamin D levels >20ng/ ml

    Outcome Measures

    Primary Outcome Measures

    1. time to 2 pronucleus (PN) membrane breakdown, first cleavage and 3, 4, 5, 6, 7, and 8 cells stages, morula and blastocyst stage (t2, t3, t4, t5, t6, t7, t8, t Morula (M), t Blastocyst (B) ) [between 17 and 120 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 years to 38 years age, 2 or less in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) attempt history, Unexplained or tubal factor infertility, Serum Follicle Stimulating Hormone (FSH) < 10, Antral Follicule Count (AFC)> 6-8
    Exclusion Criteria:
    • Male factor infertility, Presence of endometriosis or adenomyosis,Diminished ovarian reserve

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bahceci Fulya IVF Center Istanbul Fulya Turkey 34800

    Sponsors and Collaborators

    • Bahceci Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    C CELİK, Associate Professor, Bahceci Clinic
    ClinicalTrials.gov Identifier:
    NCT02365337
    Other Study ID Numbers:
    • BHC19771981
    First Posted:
    Feb 18, 2015
    Last Update Posted:
    Jan 28, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by C CELİK, Associate Professor, Bahceci Clinic
    Vitamin D
    time lapse monitoring
    embryo
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Jan 28, 2016