The Effect of Vitamin D on Fertility

NCT03890458 | Completed Phase 4

• 1 other identifier: 02
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Biochemical pregnancy

  HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test)

Study Arms (2)

Experimental

EXPERIMENTAL

Drug: DEVIT-3

Control

NO INTERVENTION

Interventions

DEVIT-3 DRUG

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Murat Özekinci

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility; Infertility, Female; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gamze Teskereci

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 26, 2019
• Study Start: May 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)