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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,150
Kwong Wah Hospital
Hong Kong, Hong Kong
RECRUITINGQueen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGLive birth rate
per embryo transfer procedure
Time frame: 10 months
Cumulative pregnancy rate within 6 months of randomization
within 6 months of randomization
Time frame: 6 months
Serum and follicular vitamin D levels
vitamin D levels
Time frame: 6 weeks
Pregnancy rate
pregnancy test positive
Time frame: 8 weeks
Clinical pregnancy rate
Presence of intrauterine gestational sac on ultrasound
Time frame: 10 weeks
Ongoing pregnancy rate
Viable pregnancy beyond 8 weeks
Time frame: 12 weeks
Adverse events
Number of women with adverse events
Time frame: 6 months
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