Vitamin D and Pregnancy Outcome in PCOS Patients

• Status: Recruiting
• Trial end date: 2022-03-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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.