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The Effect of Vitamin D on Fertility

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ClinicalTrials.gov Identifier: NCT03890458
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Akdeniz University

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


Condition or disease Intervention/treatment Phase
Infertility Infertility, Female Vitamin D Deficiency Vitamin D3 Deficiency Drug: DEVIT-3 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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.

No Intervention: Control



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890458


Locations
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Turkey
Murat Özekinci
Antalya, Turkey
Sponsors and Collaborators
Akdeniz University
Investigators
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Principal Investigator: Gamze Teskereci Akdeniz University
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Responsible Party: Akdeniz University
ClinicalTrials.gov Identifier: NCT03890458    
Other Study ID Numbers: 02
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Akdeniz University:
vitamin D
vitamin D supplementation
infertility
D vitamin deficiency
infertile women
embryo transfer
pregnancy rate
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders