Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?

NCT ID: NCT03209856

Last Updated: 2021-10-06

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2021-04-20

Brief Summary

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The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the success of IVF cycles.

Detailed Description

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The study participants are vitamin D deficient females undergoing (intra-cytoplasmic sperm injection (ICSI) trial in the age of 20 to 35 years. Serum vitamin D will be assessed. Accordingly, if they are deficient in vitamin D, they will be eligible for the study.400 vitamin D deficient women will be randomly allocated to either one of two groups. The first group will receive vitamin D supplementation in addition to the routine care. The other group will receive the routine care only. The study will be conducted in the IVF unit of department of Obstetrics and Gynecology, Cairo University.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D supplement

This group will receive weekly oral 50000 international units of vitamin D supplement for 8 weeks before the start of ICSI cycle. In addition, the routine care will be given.

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred

Routine care

This group will receive the routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred

Intervention Type DRUG

Other Intervention Names

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Calcitriol

Eligibility Criteria

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Inclusion Criteria

* Vitamin D deficient females undergoing first ICSI trial
* Age from 20 to 35 years

Exclusion Criteria

* Women undergoing ICSI trials who are vitamin D sufficient
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eman Omran

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Omran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3645

Identifier Type: -

Identifier Source: org_study_id

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