Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients

Completed

• Conditions: Infertility

• Registration Number: NCT01999608
• Lead Sponsor: Universitair Ziekenhuis Brussel

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Primary Completion: 2014-06
• Study Completion: 2015-06
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 283

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antimullerian hormone values in relation to vitamin D status	Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)	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
Antral follicle count in relation to vitamin D status	2nd-3rd day of the menstrual cycle following the determination of vitamin D levels	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)

Trial Locations

Locations (1)

Centre for Reproductive Medicine UZ Brussel; 🇧🇪 Brussels, Belgium