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| Name | Class |
|---|---|
| Kwong Wah Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Active Comparator | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | as above |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | per embryo transfer procedure | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative pregnancy rate within 6 months of randomization | within 6 months of randomization | 6 months |
| Serum and follicular vitamin D levels | vitamin D levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ka Yee Ko, MBBS | Contact | 2255 4647 | jenko@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwong Wah Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Dietary Supplement |
as above |
|
| 6 weeks |
| Pregnancy rate | pregnancy test positive | 8 weeks |
| Clinical pregnancy rate | Presence of intrauterine gestational sac on ultrasound | 10 weeks |
| Ongoing pregnancy rate | Viable pregnancy beyond 8 weeks | 12 weeks |
| Adverse events | Number of women with adverse events | 6 months |
| Queen Mary Hospital, University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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