Impact of Vitamine D Status on in Vitro Fertilization Outcomes

Study Overview
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Brief Summary
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Non skeletal effect of vitamin D have been the focus of much interest in the past decade. During the last years, special attention has been given to the impact of vitamin D on human reproduction. Its receptor is expressed in most reproductive organs including hypothalamus, pituitary gland, uterus, ovary, mammary gland and the placenta. In vitro experiments suggest that vitamin D would be involved in regulated embryo-implantation. Concerning AMH, vitamin D seems to alters AMH signaling in human granulosa cells although their circulated levels are correlated in lated reproductive aged women. The results of precedents studies about the impact of vitamin D on IVF outcomes remain conflicting The aim of our study was to assess in a large unselected population of infertile women, the impact of vitamin D deficiency on IVF outcome and to examine the relationship between serum vitamin D levels and the ovarian reserve marker AMH.

Detailed Description
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Vitamin D was measured on the sixth day of stimulation. According to vitamin D level, women were divided into 2 groups (deficiency when 25(OH)D <20 ng/ml and sufficient when 25(OH)D >20 ng/ml). Pregnancy rates were compared among these two groups after controlling age, BMI, characteristics of ovarian stimulation, number of ovocytes obtains, etc.

Official Title
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Evaluation of the Impact of Vitamine D Status on in Vitro Fertilization Outcomes in a Large Population of Infertile Women.

Conditions
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Infertility

Intervention / Treatment
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* Biological: vitamin D estimation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing IVF/ICSI in the center of medical assistance for the procreation of the french hospital of Nantes between september 2010 and may 2011. Exclusion Criteria: Women for who the cycle was interrupted during ovarian stimulation or converted in intrauterine insemination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>Women with sufficient vitamin D level, when 25(OH)D >20 ng/ml | Biological: vitamin D estimation<br>* Serum samples to estimate vitamin D status were collected on the sixth day of stimulation<br>|
| Deficient<br>women deficiency vitamin D level, when 25(OH)D <20 ng/ml | Biological: vitamin D estimation<br>* Serum samples to estimate vitamin D status were collected on the sixth day of stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory pregnancy | Serum HCG was drawn 16 days after ovocyte tapping; Patient had a repeat bHCG drawn 48 hours if they have a positive result from the first bHCG; Clinical pregnancy was defined as ultrasound documentation of fetal heart tones at seven weeks of gestation | 4 weeks to 9 month | 
| Clinical pregnancy | Serum HCG was drawn 16 days after ovocyte tapping; Patient had a repeat bHCG drawn 48 hours if they have a positive result from the first bHCG; Clinical pregnancy was defined as ultrasound documentation of fetal heart tones at seven weeks of gestation | 4 weeks to 9 month | 
| Live birth | Serum HCG was drawn 16 days after ovocyte tapping; Patient had a repeat bHCG drawn 48 hours if they have a positive result from the first bHCG; Clinical pregnancy was defined as ultrasound documentation of fetal heart tones at seven weeks of gestation | 4 weeks to 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between serum vitamin D levels and the ovarian reserve marker AMH | Serum AMH was drawn during hormonal examination on third day of natural cycle. | day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, 25(OH)D, in vitro fertilization, AMH, infertility, clinical pregnancy