Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome
NCT ID: NCT04547530
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1150 participants
INTERVENTIONAL
2021-02-11
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D
Vitamin D 50,000IU per week for 4 weeks from recruitment, followed by 50,000IU per week every 2 weeks throughout the IVF cycle. Subjects to stop own supplements and folic acid will be provided. If pregnant and fetal viability confirmed at 6 weeks gestation, switch to Materna until delivery.
If not pregnant, to continue vitamin D 50,000IU once every 2 weeks until 6 months from recruitment.
The rest of the IVF, embryo transfer procedure and antenatal care will be the same as usual practice.
Vitamin D
as above
Placebo
Placebo tablets identical to the active drug for 4 weeks from recruitment, followed by placebo tablets once every 2 weeks throughout the IVF cycle. Subjects to stop own supplements and folic acid will be provided. If pregnant and fetal viability confirmed at 6 weeks gestation, switch to Materna until delivery.
If not pregnant, to continue placebo tablets once every 2 weeks until 6 months from recruitment.
The rest of the IVF, embryo transfer procedure and antenatal care will be the same as usual practice.
Placebo
as above
Interventions
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Vitamin D
as above
Placebo
as above
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 43 years old, inclusive, at the time of signing informed consent
* Having given voluntary written informed consent
Exclusion Criteria
* 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
18 Years
43 Years
FEMALE
No
Sponsors
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Kwong Wah Hospital
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Locations
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Kwong Wah Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital, University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Shui Fan Lai, MBBS
Role: primary
Jennifer Ka Yee Ko, MBBS
Role: primary
Other Identifiers
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UW19-411
Identifier Type: -
Identifier Source: org_study_id
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