The Effect of Vitamin D on Fertility

NCT ID: NCT03890458

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Infertility Infertility, Female Vitamin D Deficiency Vitamin D3 Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

DEVIT-3

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gamze Teskereci

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Murat Özekinci

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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02

Identifier Type: -

Identifier Source: org_study_id

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