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

NCT01985672 | Completed

• 2 other identifiers: 2013/181B.U.N. 143201317807
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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

Keywords

Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  The presence of intrauterine gestational sac at 7 weeks of gestation

  4 weeks after embryo transfer

Secondary Outcomes (1)

• Biochemical pregnancy

  2 weeks after embryo transfer

Study Arms (2)

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

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

Interventions

Frozen embryo transfer PROCEDURE

Embryo transfer of frozen/thawed embryos after IVF/ICSI

Vitamin D deficient patients; Vitamin D sufficient patients

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile women undergoing a frozen ET with 1 or 2 Day 5 (blastocyst stage) embryo

You may qualify if:

• All women undergoing a frozen ET with 1 or 2 Day 5 (blastocyst stage) embryo
• Age 18-39

You may not qualify if:

• Women \> or = 40 years old
• IVM ET
• Uterine abnormalities

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Centre for Reproductive Medicine UZ Brussel

Brussels, 1090, Belgium

Location

Related Publications (6)

• Zarnani AH, Shahbazi M, Salek-Moghaddam A, Zareie M, Tavakoli M, Ghasemi J, Rezania S, Moravej A, Torkabadi E, Rabbani H, Jeddi-Tehrani M. Vitamin D3 receptor is expressed in the endometrium of cycling mice throughout the estrous cycle. Fertil Steril. 2010 May 15;93(8):2738-43. doi: 10.1016/j.fertnstert.2009.09.045. Epub 2009 Nov 6.

  PMID: 19896660 BACKGROUND

• Yoshizawa T, Handa Y, Uematsu Y, Takeda S, Sekine K, Yoshihara Y, Kawakami T, Arioka K, Sato H, Uchiyama Y, Masushige S, Fukamizu A, Matsumoto T, Kato S. Mice lacking the vitamin D receptor exhibit impaired bone formation, uterine hypoplasia and growth retardation after weaning. Nat Genet. 1997 Aug;16(4):391-6. doi: 10.1038/ng0897-391.

  PMID: 9241280 BACKGROUND

• Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.

  PMID: 22914766 BACKGROUND

• Anifandis GM, Dafopoulos K, Messini CI, Chalvatzas N, Liakos N, Pournaras S, Messinis IE. Prognostic value of follicular fluid 25-OH vitamin D and glucose levels in the IVF outcome. Reprod Biol Endocrinol. 2010 Jul 28;8:91. doi: 10.1186/1477-7827-8-91.

  PMID: 20667111 BACKGROUND

• 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.

  PMID: 19589516 BACKGROUND

• 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.

  PMID: 21835540 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Nikolaos P. Polyzos, MD PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Arne Van de Vijver, MD

  UZBrussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2013
• First Posted: November 15, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

BE (1)