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

NCT ID: NCT01985672

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Frozen embryo transfer

Intervention Type: PROCEDURE

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)

Frozen embryo transfer

Intervention Type: PROCEDURE

Embryo transfer of frozen/thawed embryos after IVF/ICSI

Interventions

Frozen embryo transfer

Embryo transfer of frozen/thawed embryos after IVF/ICSI

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Nikolaos P. Polyzos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikolaos P. Polyzos, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Arne Van de Vijver, MD

Role: PRINCIPAL_INVESTIGATOR

UZBrussel

Locations

Centre for Reproductive Medicine UZ Brussel

Brussels, , Belgium

Countries

Belgium

References

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Reference Type: BACKGROUND

PMID: 19896660 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20667111 (View on PubMed)

Ozkan S, Jindal S, Greenseid K, Shu J, Zeitlian G, Hickmon C, Pal L. Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertil Steril. 2010 Sep;94(4):1314-1319. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8.

Reference Type: BACKGROUND

PMID: 19589516 (View on PubMed)

Aleyasin A, Hosseini MA, Mahdavi A, Safdarian L, Fallahi P, Mohajeri MR, Abbasi M, Esfahani F. Predictive value of the level of vitamin D in follicular fluid on the outcome of assisted reproductive technology. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):132-7. doi: 10.1016/j.ejogrb.2011.07.006. Epub 2011 Aug 10.

Reference Type: BACKGROUND

PMID: 21835540 (View on PubMed)

Other Identifiers

B.U.N. 143201317807

Identifier Type: -

Identifier Source: secondary_id

2013/181

Identifier Type: -

Identifier Source: org_study_id