Clinical trial · Interventional
Vitamin D and Pregnancy Outcome in PCOS Patients
Vitamin D Supplementation Prior to in Vitro Fertilization in Women With Polycystic Ovary Syndrome: a Protocol of a Multicenter Randomised Double-blind Placebo-controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| in Vitro Fertilization | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D
- description
- Participants in the intervention group will be treated with vitamin D 4000IU (800IU per pill, take five pills once each day) per day for around 12 weeks (till the triggering day).
- interventionNames
- Drug: vitamin D
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants in the control group will be treated with equal amount of placebo tablets per day for the same duration.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Number of Participants with live birth
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 42 Years
Show eligibility criteria text
Inclusion criteria 1. Women aged 20 to 42 years old; 2. Diagnosed with PCOS (Rotterdam Criteria); 3. Scheduled for IVF; 4. Written informed consent. Exclusion criteria 1. Women who had three or more failed IVF cycles; 2. Women scheduled for preimplantation genetic testing; 3. Known Vitamin D allergy; 4. Women with a history of chronic absorption syndrome or bile dysplasia, or parathyroid dysfunction, or kidney stones, or blood Calcium ion concentration greater than 2.6mmol/L (normal value 2.25 - 2.75mmol/L (9 to 11mg/dl), or hyperphosphataemia (1.61mmol/L), or metabolic-related bone disease, or chronic diseases that may cause bone abnormalities (liver and kidney insufficiency); 5. Women receiving treatments for tuberculosis, convulsions, and epilepsy because medications treating these diseases may affect the metabolism of vitamin D. 6. Women undergoing an IVF treatment with donor oocytes.
References
Publications (2)
- DERIVEDHu 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. PMID 41702641
- DERIVEDHu 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. PMID 33293396