Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients

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).

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Reproductive Medicine UZ Brussel

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Antimullerian hormone values in relation to vitamin D status

Time frame: 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

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Dec 3, 2013
Registry last updated: Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed