Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients

NCT ID: NCT01999608

Last Updated: 2016-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Infertility

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Vitamin D deficient patients

Serum 25-OH Vitamin D levels \<20ng/L

No interventions assigned to this group

Vitamin D sufficient patients

Serum 25-OH Vitamin D levels ≥20ng/L

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos P. Polyzos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolaos P. Polyzos, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Arne Van de Vijver, MD

Role: PRINCIPAL_INVESTIGATOR

UZBrussel

Locations

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Centre for Reproductive Medicine UZ Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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)

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.

Reference Type BACKGROUND
PMID: 20667111 (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)

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.

Reference Type BACKGROUND
PMID: 22914766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24210230 (View on PubMed)

Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian 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.

Reference Type BACKGROUND
PMID: 22508713 (View on PubMed)

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 antimullerian 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.

Reference Type BACKGROUND
PMID: 22494925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9241280 (View on PubMed)

Other Identifiers

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2013/180

Identifier Type: -

Identifier Source: org_study_id

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