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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547530
• Other study ID #: UW19-411
• Status: Recruiting
• Phase: Phase 4
• Start date: February 11, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: Jennifer Ka Yee Ko, MBBS
• Phone: 2255 4647
• Email: jenko[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Dietary Supplement:
• Vitamin D
as above
• Placebo
as above

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Queen Mary Hospital, University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	per embryo transfer procedure	10 months
Secondary	Cumulative pregnancy rate within 6 months of randomization	within 6 months of randomization	6 months
Secondary	Serum and follicular vitamin D levels	vitamin D levels	6 weeks
Secondary	Pregnancy rate	pregnancy test positive	8 weeks
Secondary	Clinical pregnancy rate	Presence of intrauterine gestational sac on ultrasound	10 weeks
Secondary	Ongoing pregnancy rate	Viable pregnancy beyond 8 weeks	12 weeks
Secondary	Adverse events	Number of women with adverse events	6 months