The Effect of Vitamin D on Fertility
Primary Purpose
Infertility, Infertility, Female, Vitamin D Deficiency
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
DEVIT-3
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility focused on measuring vitamin D, vitamin D supplementation, infertility, D vitamin deficiency, infertile women, embryo transfer, pregnancy rate
Eligibility Criteria
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
Sites / Locations
- Murat Özekinci
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Outcomes
Primary Outcome Measures
Blood Vitamin D level
The vitamin D blood test was measured by the level of 25(OH)D.
Blood Vitamin D level
The vitamin D blood test was measured by the level of 25(OH)D.
Secondary Outcome Measures
Biochemical pregnancy
The pregnancy test was measured level of HCG in the blood.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03890458
Brief Title
The Effect of Vitamin D on Fertility
Official Title
Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Infertility, Female, Vitamin D Deficiency, Vitamin D3 Deficiency
Keywords
vitamin D, vitamin D supplementation, infertility, D vitamin deficiency, infertile women, embryo transfer, pregnancy rate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
DEVIT-3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Vitamin D level
Description
The vitamin D blood test was measured by the level of 25(OH)D.
Time Frame
The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest)
Title
Blood Vitamin D level
Description
The vitamin D blood test was measured by the level of 25(OH)D.
Time Frame
The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest)
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
The pregnancy test was measured level of HCG in the blood.
Time Frame
HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Teskereci
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Murat Özekinci
City
Antalya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Vitamin D on Fertility
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