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

Infertility Clinical Trial

Official title:

Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer. A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985672
• Other study ID #: 2013/181
• Secondary ID: B.U.N. 143201317
• Status: Completed
• Phase: N/A
• First received: November 10, 2013
• Last updated: August 5, 2015
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: July 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View Citation

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. — View Citation

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):1314-9. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	The presence of intrauterine gestational sac at 7 weeks of gestation	4 weeks after embryo transfer	No
Secondary	Biochemical pregnancy	Positive pregnancy test 2 weeks after embryo transfer	2 weeks after embryo transfer	No