NCT04082650Completed
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 · Last updated 29 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 876 (actual)
- First submitted
- 4 Sept 2019
- Start date
- 15 Oct 2020
- Primary completion date
- 23 May 2024
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- NCT number
- NCT04082650
What you commit to
- Study type: Interventional
- Participants enrolled: 876
- From 15 Oct 2020 to the primary completion date, 23 May 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women receiving treatments for tuberculosis, convulsions, and epilepsy because medications treating these diseases may affect the metabolism of vitamin D.
- Women undergoing an IVF treatment with donor oocytes.
Other illness
- Known Vitamin D allergy;
Lab values
- 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);
Other
- Women who had three or more failed IVF cycles;
- Women scheduled for preimplantation genetic testing;
Who the study is looking for
- Women aged 20 to 42 years old;
- Diagnosed with PCOS (Rotterdam Criteria);
- Scheduled for IVF;
- Written informed consent.
Age in the registry: 20 years to 42 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Women's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.