The Effect of Vitamin D on Fertility

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890458
• Other study ID #: 02
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: March 2019
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Vitamin D Deficiency
• Vitamin D3 Deficiency

Intervention

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.

Locations

Country	Name	City	State
Turkey	Murat Özekinci	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)