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Completed

NCT Number: NCT03890458

The Effect of Vitamin D on Fertility

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

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Key information

Conditions

Infertility Avitaminosis Deficiency Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility, Female Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Urogenital Diseases Vitamin D Deficiency Vitamin D3 Deficiency

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Murat Özekinci

Antalya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Blood Vitamin D level

    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)

    The vitamin D blood test was measured by the level of 25(OH)D.

  2. Blood Vitamin D level

    Time frame: The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest)

    The vitamin D blood test was measured by the level of 25(OH)D.

Secondary outcomes

  1. Biochemical pregnancy

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

    The pregnancy test was measured level of HCG in the blood.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2019
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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