NCT04547530

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

A Randomized Double-blind Placebo-controlled Trial to Investigate the Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,150 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	as above
DIETARY_SUPPLEMENT	Placebo	as above

Timeline

• Start date: 2021-02-11
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-09-14
• Last updated: 2022-12-05

Locations

2 sites across 1 country: Hong Kong