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

Phase

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT04547530

UW19-411

Ages 18-43
Female

Study 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.

Eligibility Criteria

Inclusion

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

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 Dsensitivity, altered vitamin D metabolism and/or hypercalcemia, including history ofrenal/ureteral stones, parathyroid disease, renal or liver failure, current use ofanticonvulsants, current use of steroid
Allergy to vitamin D
Abnormal serum calcium values

Study Design

February 11, 2021

December 31, 2024

Study 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.

Connect with a study center

Kwong Wah Hospital
Hong Kong,
Hong Kong
Active - Recruiting
Queen Mary Hospital, University of Hong Kong
Hong Kong,
Hong Kong
Active - Recruiting

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