The Effect of Vitamin D on Fertility

Study Overview
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Brief Summary
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Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles. Design: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the control group. Intervention(s): At the beginning of the infertility treatment, the experimental group took vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile women includes regulation of a diet rich in vitamin D, educational and motivational interviews about insolation, and taking vitamin D orally. Main Outcome Measure(s): 25(OH)D and beta HCG levels

Official Title
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Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles

Conditions
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Infertility, Infertility, Female, Vitamin D Deficiency, Vitamin D3 Deficiency

Intervention / Treatment
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* Drug: DEVIT-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old literate in Turkish voluntary participation primarily infertile had undergone controlled ovarian hyperstimulation and had a fresh ET vitamin D levels lower than 30ng/mL before infertility treatment Exclusion Criteria: patients with uncorrected congenital or acquired uterine anomalies bone, parathyroid gland, kidney and liver disorders use of anticonvulsants/antacid drugs taking dietary supplements contain vitamin D secondary infertility

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Drug: DEVIT-3<br>* The physicians gave the women in the experimental group vitamin D oral drops in an ampoule of 300,000 IU and a vial of 50,000 IU to take during the IVF treatment. Written and verbal information about how to take vitamin D was provided to the participants by the nurses. The women took 300,000 IU vitamin D orally for the first week. In the second week of the treatment, 50,000 IU vitamin D (15 drops/day) was used as maintenance dose until the pregnancy test day.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Vitamin D level | The vitamin D blood test was measured by the level of 25(OH)D. | The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest) | 
| Blood Vitamin D level | The vitamin D blood test was measured by the level of 25(OH)D. | The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy | The pregnancy test was measured level of HCG in the blood. | HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, vitamin D supplementation, infertility, D vitamin deficiency, infertile women, embryo transfer, pregnancy rate