NCT03209856

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 6, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

3.7 years

First QC Date

July 4, 2017

Last Update Submit

October 5, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    This outcome will be calculated by a statistician

    It will be calculated 1 year after enrollment of the first patient in the study

Study Arms (2)

Vitamin D supplement

EXPERIMENTAL

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.

Drug: Vitamin D

Routine care

NO INTERVENTION

This group will receive the routine care.

Interventions

Vitamin DDRUG

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

Also known as: Calcitriol
Vitamin D supplement

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women undergoing ICSI trials who are vitamin D sufficient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Vitamin DCalcitriol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Eman Omran, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

July 6, 2017

Primary Completion

March 20, 2021

Study Completion

April 20, 2021

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations

EG(1)