Vitamin D and Pregnancy Outcome in PCOS Patients

  • STATUS
    Recruiting
  • End date
    Mar 10, 2022
  • participants needed
    860
  • sponsor
    Women's Hospital School Of Medicine Zhejiang University
Updated on 26 January 2021

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.

Description

Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women with a child-bearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates in these women. However, evidence regarding the effectiveness of vitamin D treatment in women with PCOS is inconclusive. 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.

The investigators plan to enroll women with PCOS scheduled for IVF. 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. All IVF procedures will be carried out following a routine method in each center. Women will be followed up until six months after randomisation for those who fail to get pregnant after the completion of the first embryo transfer or delivery for those who get pregnant after the first embryo transfer. The primary outcome is live birth after the first embryo transfer. Primary analysis will be by intention-to-treat analysis. The investigators plan to recruit 860 women to demonstrate women treated with vitamin D have a higher live birth rate than those treated with placebo (48% versus 38%), accounting for 10% loss to follow-up with a significance level at 0.05 and a power of 80%.

Details
Condition OVARIAN CYST, In Vitro Fertilization, Polycystic Ovary Syndrome, Ovarian Cysts, Polycystic Ovarian Syndrome, pcos, polycystic ovary disease
Treatment Placebo, Vitamin D
Clinical Study IdentifierNCT04082650
SponsorWomen's Hospital School Of Medicine Zhejiang University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women aged 20 to 42 years old
Diagnosed with PCOS (Rotterdam Criteria)
Scheduled for IVF
Written informed consent

Exclusion Criteria

Women who had three or more failed IVF cycles
Women scheduled for preimplantation genetic testing
Known Vitamin D allergy
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)
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
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