Vitamin D and Pregnancy Outcome in PCOS Patients
Summary
This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS. Women with PCOS scheduled for IVF will be enrolled. Eligible participants will be randomised 1:1 to receive oral capsules of 4000IU vitamin D per day or placebo for around 12 weeks until the day of triggering.
Timeline
- Start
- 2020-10-15
- Primary completion
- 2024-05-23
- Completion
- 2025-01-27
Outcome
Missed primary endpoint
paper 226 (52.0%) live births occurred in the vitamin D group and 216 (50.2%) in the placebo group (adjusted risk ratio 1.03, 95% confidence interval 0.91 to 1.18). PMID 41702641 ↗
paper this does not translate to improved live birth rates after the first transfer for patients with polycystic ovary syndrome. PMID 41702641 ↗
Publications
- Hu KL, Liao T, Wu Q, Ma X, Cao Y, Tan J, Tian L, Wang J, Yin J, Liu Y, Zhao J, Zhao S, Li M, Cai L, Liu FT, Gan K, Xu Y, Wang Y, Cai J, Zheng B, Ma Y, Ma Q, Zheng J, Pu X, Zhang H, Hao C, Xie Q, Zhang C, Jiang L, Zhang S, Yan L, Meng Q, Li W, Mol BW, Li R, Wang R, Zhang D; VitD-PCOS trial group. Vitamin D supplementation before in vitro fertilisation in women with polycystic ovary syndrome: multicentre, double blind, placebo controlled, randomised clinical trial. BMJ. 2026 Feb 17;392:e087438. doi: 10.1136/bmj-2025-087438.
- Hu KL, Gan K, Wang R, Li W, Wu Q, Zheng B, Zou L, Zhang S, Liu Y, Wu Y, Chen R, Cao W, Yang S, Liu FT, Tian L, Zeng H, Xu H, Qiu S, Yang L, Chen X, Pan X, Wu X, Mol BW, Li R, Zhang D. Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2020 Dec 8;10(12):e041409. doi: 10.1136/bmjopen-2020-041409.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin D | Other / unclassified | 4000 iu | Oral |