Clinical trial NCT04547530: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
First posted: 2020-09-14
Enrollment: 1150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Live birth rate
timeFrame: 10 months
Secondary outcomes:
measure: Cumulative pregnancy rate within 6 months of randomization
timeFrame: 6 months
measure: Serum and follicular vitamin D levels
timeFrame: 6 weeks
measure: Pregnancy rate
timeFrame: 8 weeks
measure: Clinical pregnancy rate
timeFrame: 10 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, University of Hong Kong
Study officials:
References: