Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes

Study Overview
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Brief Summary
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Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

Detailed Description
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The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge.

Official Title
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Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes

Conditions
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Infertility, Vitamin D Deficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles Exclusion Criteria: Infertile women aged > 38 undergoing fresh invitro fertilization cycles Patients undergoing frozen embryo transfers Patients undergoing donor-egg cycles Patients who have a contraindication to receiving Vitamin D (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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 |
| --- | --- |
| patients with Vit D level of < 20ng/mL: Group 1<br>randomized to receive 400 IU of vitamin D per day | |
| patients with Vit D levels <20ng/mL: Group 2<br>Randomized to receive 2000IU of Vitamin D per day | |
| patients with vit D levels between 20-30 ng/mL: Group 3<br>Randomized to receiving placebo | |
| patients with vit D levels between 20-30 ng/mL: Group 4<br>Randomized to receive 400IU of vitamin D per day | |
| patients with vit D levels between 20-30 ng/mL: Group 5<br>Randomized to receive 2000IU of vitamin D per day | |
| patients with vit D levels > 30ng/mL: Group 6<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Serum hCG will be drawn per routine IVF protocol (  10 days after embryo transfer). Patients will have a repeat bHCG drawn 48hrs if they have a positive result from the first bHCG test. Clinical pregnancy will be defined as ultrasound documentation of fetal heart tones. | assessed at conclusion of the study (  1 yr) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supplementation, Vitamin D deficiency, Infertility, Clinical pregnancy rates