The Effect of Vitamin D on Fertility

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

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

Study Overview

• Status: Completed
• Conditions: Infertility; Vitamin D Deficiency; Infertility, Female; Vitamin D3 Deficiency
• Intervention / Treatment: Drug: DEVIT-3

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Murat Özekinci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Experimental	Drug: DEVIT-3; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Gamze Teskereci, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: infertility; embryo transfer; vitamin D; pregnancy rate; vitamin D supplementation; D vitamin deficiency; infertile women
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Infertility; Vitamin D Deficiency; Infertility, Female
• Other Study ID Numbers: 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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