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Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kwong Wah HospitalRecruiting
  • Queen Mary Hospital, University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Live birth rate
per embryo transfer procedure

Secondary Outcome Measures

Cumulative pregnancy rate within 6 months of randomization
within 6 months of randomization
Serum and follicular vitamin D levels
vitamin D levels
Pregnancy rate
pregnancy test positive
Clinical pregnancy rate
Presence of intrauterine gestational sac on ultrasound
Ongoing pregnancy rate
Viable pregnancy beyond 8 weeks
Adverse events
Number of women with adverse events

Full Information

First Posted
September 7, 2020
Last Updated
December 1, 2022
Sponsor
The University of Hong Kong
Collaborators
Kwong Wah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04547530
Brief Title
Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome
Official Title
A Randomized Double-blind Placebo-controlled Trial to Investigate the Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Kwong Wah Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Patients undergoing IVF treatment cycle at Queen Mary Hospital and Kwong Wah Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) vitamin D or (ii) placebo group in a 1:1 allocation ratio by computer-generated random numbers one month before IVF. Subjects allocated to the vitamin D group will take vitamin D 50,000IU per week from recruitment for 4 weeks, followed by 50,000IU once every 2 weeks throughout the IVF cycle until fetal viability is confirmed at 6 weeks (if pregnant), after which they will be switched to Materna. If not pregnant, they will continue Vitamin D 50,000IU once every 2 weeks until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer. Subjects allocated to the placebo group will take placebo tablets which will be identical to the active drug. If pregnant and fetal viability is confirmed at 6 weeks, they will be switched to Materna. If not pregnant, they will continue the placebo tablets until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer. The clinician and patients will both be blinded to the randomization throughout the course of treatment. The live birth rate of the two groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
as above
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
as above
Primary Outcome Measure Information:
Title
Live birth rate
Description
per embryo transfer procedure
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Cumulative pregnancy rate within 6 months of randomization
Description
within 6 months of randomization
Time Frame
6 months
Title
Serum and follicular vitamin D levels
Description
vitamin D levels
Time Frame
6 weeks
Title
Pregnancy rate
Description
pregnancy test positive
Time Frame
8 weeks
Title
Clinical pregnancy rate
Description
Presence of intrauterine gestational sac on ultrasound
Time Frame
10 weeks
Title
Ongoing pregnancy rate
Description
Viable pregnancy beyond 8 weeks
Time Frame
12 weeks
Title
Adverse events
Description
Number of women with adverse events
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Ka Yee Ko, MBBS
Phone
2255 4647
Email
jenko@hku.hk
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shui Fan Lai, MBBS
Facility Name
Queen Mary Hospital, University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Ka Yee Ko, MBBS

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome

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