NCT04547530

Brief Summary

This is a randomized-controlled trial evaluating the effect of the use of vitamin D supplementation on the live birth rate in women undergoing in vitro fertilization (IVF). The hypothesis is that administration of vitamin D can increase the live birth rate for women undergoing IVF.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,150

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2021

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 5, 2022

Status Verified

July 1, 2022

Enrollment Period

2.9 years

First QC Date

September 7, 2020

Last Update Submit

December 1, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    per embryo transfer procedure

    10 months

Secondary Outcomes (6)

  • Cumulative pregnancy rate within 6 months of randomization

    6 months

  • Serum and follicular vitamin D levels

    6 weeks

  • Pregnancy rate

    8 weeks

  • Clinical pregnancy rate

    10 weeks

  • Ongoing pregnancy rate

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Vitamin D 50,000IU per week for 4 weeks from recruitment, followed by 50,000IU per week every 2 weeks throughout the IVF cycle. Subjects to stop own supplements and folic acid will be provided. If pregnant and fetal viability confirmed at 6 weeks gestation, switch to Materna until delivery. If not pregnant, to continue vitamin D 50,000IU once every 2 weeks until 6 months from recruitment. The rest of the IVF, embryo transfer procedure and antenatal care will be the same as usual practice.

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo tablets identical to the active drug for 4 weeks from recruitment, followed by placebo tablets once every 2 weeks throughout the IVF cycle. Subjects to stop own supplements and folic acid will be provided. If pregnant and fetal viability confirmed at 6 weeks gestation, switch to Materna until delivery. If not pregnant, to continue placebo tablets once every 2 weeks until 6 months from recruitment. The rest of the IVF, embryo transfer procedure and antenatal care will be the same as usual practice.

Dietary Supplement: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

as above

Vitamin D
PlaceboDIETARY_SUPPLEMENT

as above

Placebo

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women undergoing IVF
  • Aged between 18 and 43 years old, inclusive, at the time of signing informed consent
  • Having given voluntary written informed consent

You may not qualify if:

  • Already taking vitamin D
  • Undergoing preimplantation genetic testing
  • Use of donor oocytes or donor embryos
  • Presence of hydrosalpinx not corrected surgically
  • Active tuberculosis/ receiving therapy for tuberculosis
  • History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, including history of renal/ureteral stones, parathyroid disease, renal or liver failure, current use of anticonvulsants, current use of steroid
  • Allergy to vitamin D
  • Abnormal serum calcium values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kwong Wah Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Jennifer Ka Yee Ko, MBBS

CONTACT

2255 4647jenko@hku.hk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

February 11, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

December 5, 2022

Record last verified: 2022-07

Locations

HK(2)