Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients

Infertility Clinical Trial

Official title:

Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients. A Cross-sectional Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999608
• Other study ID #: 2013/180
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: June 1, 2016
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The role of vitamin D deficiency in female reproduction remains controversial. Early retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium.

Taking into account that knock-out experiments have shown that vitamin D receptor null mice not only experience uterine hypoplasia but also impaired folliculogenesis, it might be hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian reserve. This may be further supported by previous reports demonstrating that serum 25-OH Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age.

The aim of this study is to examine through a large set of prospectively recruited infertile women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

infertile women less than 42 years old, undergoing their first treatment cycle in our institution

Exclusion Criteria:

vitamin D supplements, taking medication for systematic disease or having potential iatrogenic (e.g. ovarian surgery, gonadotoxic therapy) or known genetic cause of ovarian loss

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Vitamin D Deficiency

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 (8)

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

Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Müllerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16. — View Citation

Merhi ZO, Seifer DB, Weedon J, Adeyemi O, Holman S, Anastos K, Golub ET, Young M, Karim R, Greenblatt R, Minkoff H. Circulating vitamin D correlates with serum antimüllerian hormone levels in late-reproductive-aged women: Women's Interagency HIV Study. Fertil Steril. 2012 Jul;98(1):228-34. doi: 10.1016/j.fertnstert.2012.03.029. Epub 2012 Apr 10. — 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

Rudick BJ, Ingles SA, Chung K, Stanczyk FZ, Paulson RJ, Bendikson KA. Influence of vitamin D levels on in vitro fertilization outcomes in donor-recipient cycles. Fertil Steril. 2014 Feb;101(2):447-52. doi: 10.1016/j.fertnstert.2013.10.008. Epub 2013 Nov 5. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antimullerian hormone values in relation to vitamin D status	On the day of the preliminary testing (irrespective of the day of the menstrual cycle) patients will have their serum 25-OH-vitamin D and antimullerian hormone levels determined. 25-OH-vitamin D and antimullerian hormone levels will be measured in samples retrieved on the same day	Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)	No
Primary	Antral follicle count in relation to vitamin D status	On the following cycle of the measurement of serum 25-OH-Vitamin D and AMH levels patient will have a transvaginal ultrasound to determine the antral follicle count (AFC)	2nd-3rd day of the menstrual cycle following the determination of vitamin D levels	No