Clinical trial NCT01985672: Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer
Official title: Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer. A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women undergoing a frozen ET with 1 or 2 Day 5 (blastocyst stage) embryo

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: 2 weeks after embryo transfer
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Nikolaos P. Polyzos, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZBrussel
name: Arne Van de Vijver, MD
role: PRINCIPAL_INVESTIGATOR
References:
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