Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT01999608
Collaborator
(none)
283
1
22
12.9

Study Details

Study Description

Brief Summary

The role of vitamin D deficiency in female reproduction remains controversial. Early retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium.

Taking into account that knock-out experiments have shown that vitamin D receptor null mice not only experience uterine hypoplasia but also impaired folliculogenesis, it might be hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian reserve. This may be further supported by previous reports demonstrating that serum 25-OH Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age.

The aim of this study is to examine through a large set of prospectively recruited infertile women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    283 participants
    Time Perspective:
    Prospective
    Official Title:
    Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients. A Cross-sectional Analysis
    Study Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Vitamin D deficient patients

    Serum 25-OH Vitamin D levels <20ng/L

    Vitamin D sufficient patients

    Serum 25-OH Vitamin D levels ≥20ng/L

    Outcome Measures

    Primary Outcome Measures

    1. Antimullerian hormone values in relation to vitamin D status [Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)]

      On the day of the preliminary testing (irrespective of the day of the menstrual cycle) patients will have their serum 25-OH-vitamin D and antimullerian hormone levels determined. 25-OH-vitamin D and antimullerian hormone levels will be measured in samples retrieved on the same day

    2. Antral follicle count in relation to vitamin D status [2nd-3rd day of the menstrual cycle following the determination of vitamin D levels]

      On the following cycle of the measurement of serum 25-OH-Vitamin D and AMH levels patient will have a transvaginal ultrasound to determine the antral follicle count (AFC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    infertile women less than 42 years old, undergoing their first treatment cycle in our institution

    Exclusion Criteria:

    vitamin D supplements, taking medication for systematic disease or having potential iatrogenic (e.g. ovarian surgery, gonadotoxic therapy) or known genetic cause of ovarian loss

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Reproductive Medicine UZ Brussel Brussels Belgium 1090

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    • Principal Investigator: Nikolaos P. Polyzos, MD PhD, Universitair Ziekenhuis Brussel
    • Principal Investigator: Arne Van de Vijver, MD, UZBrussel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nikolaos P. Polyzos, Principal Investigator, Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT01999608
    Other Study ID Numbers:
    • 2013/180
    First Posted:
    Dec 3, 2013
    Last Update Posted:
    Jun 2, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by Nikolaos P. Polyzos, Principal Investigator, Universitair Ziekenhuis Brussel
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 2, 2016