Clinical trial NCT01999608: Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients
Official title: Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients. A Cross-sectional Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 283
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women 18-43 years old undergoing IVF/ICSI

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Antimullerian hormone values in relation to vitamin D status
timeFrame: Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)
measure: Antral follicle count in relation to vitamin D status
timeFrame: 2nd-3rd day of the menstrual cycle following the determination of vitamin D levels
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Nikolaos P. Polyzos, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZBrussel
name: Arne Van de Vijver, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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