Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT01985672
Collaborator
(none)
280
1
23
12.2

Study Details

Study Description

Brief Summary

Vitamin D receptors are present and differently expressed in murine endometrium and ovary throughout the estrous cycle , whereas knock-out experiments have shown that vitamin D receptor null mice experience uterine hypoplasia and impaired folliculogenesis.

Only few retrospective studies examining the role of vitamin D levels in infertile patients have been published up to date, whereas results are strongly contradictory, with some supporting that maternal vitamin D deficiency is associated with lower pregnancy rates and others demonstrating that vitamin D deficiency does not affect final reproductive outcome.

Finally, a recent retrospective study postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium, given that vitamin D deficiency was not correlated with ovarian stimulation characteristics or with markers of embryo quality in this study.

In order to examine a potential negative effect of vitamin D deficiency on pregnancy rates, mediated through the endometrium, the aim of the current study was to examine the impact of vitamin D levels on pregnancy rates only in an infertile population undergoing embryo transfer of frozen-thawed embryos.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Frozen embryo transfer

Study Design

Study Type:
Observational
Actual Enrollment :
280 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer. A Prospective Cohort Study
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Vitamin D deficient patients

Serum 25-OH Vitamin D levels <20ng/L undergoing Frozen embryo transfer (vitamin D levels are measured on the day of embryo transfer)

Procedure: Frozen embryo transfer
Embryo transfer of frozen/thawed embryos after IVF/ICSI

Vitamin D sufficient patients

Serum 25-OH Vitamin D levels >20ng/L undergoing Frozen embryo transfer (vitamin D levels are measured on the day of embryo transfer)

Procedure: Frozen embryo transfer
Embryo transfer of frozen/thawed embryos after IVF/ICSI

Outcome Measures

Primary Outcome Measures

  1. Clinical pregnancy [4 weeks after embryo transfer]

    The presence of intrauterine gestational sac at 7 weeks of gestation

Secondary Outcome Measures

  1. Biochemical pregnancy [2 weeks after embryo transfer]

    Positive pregnancy test 2 weeks after embryo transfer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All women undergoing a frozen ET with 1 or 2 Day 5 (blastocyst stage) embryo

  • Age 18-39

Exclusion Criteria:
  • Women > or = 40 years old

  • IVM ET

  • Uterine abnormalities

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:
NCT01985672
Other Study ID Numbers:
  • 2013/181
  • B.U.N. 143201317807
First Posted:
Nov 15, 2013
Last Update Posted:
Aug 6, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Nikolaos P. Polyzos, Principal Investigator, Universitair Ziekenhuis Brussel
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2015