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
Wentao Li,
Rui Wang,
Ben W Mol,
Rong Li,
Xiao Chen,
Yifeng Liu,
Han Zeng,
Shuo Yang,
Dan Zhang,
Yiqing Wu,
Kai-Lun Hu,
Kwanghann Gan,
Qiongfang Wu,
Beihong Zheng,
Libo Zou,
Su Zhang,
Ruixue Chen,
Wushuang Cao,
Fen-Ting Liu,
Lifeng Tian,
Huiling Xu,
Shumin Qiu,
Lihua Yang,
Xiaoqin Pan,
Xiaoyun Wu
Affiliations
Wentao Li
Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia
Rui Wang
1 Beijing Advanced Innovation Center for Genomics, Department of General Surgery, College of Life Sciences, Third Hospital, Peking University, Beijing, China
Ben W Mol
Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia
Rong Li
1 Department of Biochemistry and Molecular Medicine, School of Medicine and Health Sciences, The George Washington University, Washington, District of Columbia, USA
Xiao Chen
1 Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Yifeng Liu
Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics, Ministry of Education, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Han Zeng
Department of Urology, Zhongshan Hospital, Fudan University, Shanghai, China
Shuo Yang
Center of Oral Implantology, Stomatological Hospital, School of Stomatology, Southern Medical University, Guangzhou, China
Dan Zhang
2Medical Center Leeuwarden, Rheumatology, Leeuwarden, Netherlands
Yiqing Wu
13 Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China
Kai-Lun Hu
Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics, Ministry of Education, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Kwanghann Gan
Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics, Ministry of Education, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Qiongfang Wu
Reproductive Medicine Center, Jiangxi Maternal and Child Health Hospital, Nanchang, China
Beihong Zheng
Reproductive Medicine Center, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China
Libo Zou
Department of Reproductive Medicine, Jinhua People’s Hospital, Jinhua, China
Su Zhang
School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
Ruixue Chen
Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics, Ministry of Education, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Wushuang Cao
Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics, Ministry of Education, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Fen-Ting Liu
Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, China
Lifeng Tian
Reproductive Medicine Center, Jiangxi Maternal and Child Health Hospital, Nanchang, China
Huiling Xu
Reproductive Medicine Center, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China
Shumin Qiu
Reproductive Medicine Center, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China
Lihua Yang
1 School of Nursing, Jiangsu Health Vocational College, Nanjing, Jiangsu Province, China
Xiaoqin Pan
Department of Obstetrics and Gynaecology, Huzhou Maternity and Child Health Care Hospital, Huzhou, China
Xiaoyun Wu
Department of Obstetrics and Gynaecology, Huzhou Maternity and Child Health Care Hospital, Huzhou, China
Introduction Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women of childbearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates. However, evidence regarding the effectiveness of vitamin D supplementation in women with PCOS is inconclusive. This multicentre randomised, double-blinded, placebo-controlled trial aims to evaluate the effectiveness of vitamin D supplementation prior to in vitro fertilisation (IVF) on the live birth rate in women with PCOS.Methods and analysis We plan to enrol women with PCOS scheduled for IVF. After informed consent, eligible participants will be randomised in a 1:1 ratio to receive oral capsules of 4000 IU vitamin D per day or placebo for around 12 weeks until the day of triggering. All IVF procedures will be carried out routinely in each centre. The primary outcome is live birth after the first embryo transfer. The primary analysis will be by intention-to-treat analysis. To demonstrate or refute that treatment with vitamin D results in a 10% higher live birth rate than treatment with placebo, we need to recruit 860 women (48% vs 38% difference, anticipating 10% loss to follow-up and non-compliance, significance level 0.05 and power 80%).Ethics and dissemination This study has been approved by the Ethics Committee in Women’s Hospital of Zhejiang University on 2 March 2020 (reference number: IRB-20200035-R). All participants will provide written informed consent before randomisation. The results of the study will be submitted to scientific conferences and a peer-reviewed journal.Trial registration number NCT04082650.
