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

Completed

• Conditions: Infertility
• Interventions: Procedure: Frozen embryo transfer

• Registration Number: NCT01985672
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-10
• Study First Submitted QC: 2013-11-10
• Study First Posted: 2013-11-15
• Primary Completion: 2014-06
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamin D sufficient patients	Frozen embryo transfer	Serum 25-OH Vitamin D levels \>20ng/L undergoing Frozen embryo transfer (vitamin D levels are measured on the day of embryo transfer)
Vitamin D deficient patients	Frozen embryo transfer	Serum 25-OH Vitamin D levels \<20ng/L undergoing Frozen embryo transfer (vitamin D levels are measured on the day of embryo transfer)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	4 weeks after embryo transfer	The presence of intrauterine gestational sac at 7 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy	2 weeks after embryo transfer	Positive pregnancy test 2 weeks after embryo transfer

Trial Locations

Locations (1)

Centre for Reproductive Medicine UZ Brussel; 🇧🇪 Brussels, Belgium