Vitamin D and Pregnancy Outcome in PCOS Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 820
Summary
- Conditions
- in Vitro Fertilization
- Polycystic Ovary Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Participants and most researchers will be unaware of the actual grouping. Only two researchers who are not involved in participant management or data analysis will be aware of the grouping. Vitamin D and placebo pills with identical package, size, colour and appearance will be used in this trial. In general, there should be no need to unblind the allocation. If urgent unbinding to participants is necessary, the allocation will be disclosed to the treating physician.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 42 years
- Gender
- Only males
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 effe...
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%.
Tracking Information
- NCT #
- NCT04082650
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dan Zhang, M.D. Ph.D. Women's Hospital School Of Medicine Zhejiang University
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