Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome

Study Overview
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Brief Summary
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Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries . The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Detailed Description
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Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries . The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Official Title
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Serum Vitamin D Level in Subfertile Women and Its Association With Ovarian Reserve and IVF Outcome.

Conditions
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VITAMIN D Disorders

Intervention / Treatment
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* Other: monitor reproductive outcome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subfertile women, Indication for IVF, 20-42 yrs of age. Exclusion Criteria: Women on therapeutic supplementation for Vitamin D Deficiency, Recurrent high order implantation failure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal vitamin D levels group<br>MORE THAN 20 NG/ML VITAMIN D LEVELS | Other: monitor reproductive outcome<br> <br> |
| Deficient Vitamin D GROUP<br>LESS THAN 20 NG/ML LEVELS | Other: monitor reproductive outcome<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 14 days post oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH (antimullerian hormone) Levels |  | day 2-3 of the index cycle | 
| AFC (antral follicle count) |  | DAY 2-3 OF INDEX CYCLE | 
| Number of oocytes retreived |  | Two weeks from the last menstrual period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum vitamin D levels, ovarian reserve, 25 OHD3, IVF, pregnancy outcome