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Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial
  1. Caixia Lei1,2,
  2. Yilun Sui2,
  3. Jiangfeng Ye3,
  4. Yao Lu4,
  5. Ji Xi5,
  6. Yun Sun4,
  7. Li Jin5,
  8. Xiaoxi Sun2,6
  1. 1Prenatal Diagnosis Center, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
  2. 2Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China
  3. 3Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
  4. 4Reproductive Medical Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
  5. 5Reproductive Medical Center, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
  6. 6Key Laboratory of Female Reproductive Endocrine Related Diseases, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
  1. Correspondence to Dr Xiaoxi Sun; xiaoxi_sun{at}


Introduction Pregnancy loss (PL) is an adverse life event, and there is no proven effective treatment for recurrent PL (RPL). Preimplantation genetic screening (PGS) can be performed to reduce the risks of PL; however, there is still no solid scientific evidence that PGS improves outcomes for couples experiencing RPL. Comprehensive chromosome screening (PGS2.0) has become a routine practice in in vitro fertilisation (IVF) clinics. Previous studies based on PGS1.0 with a focus on RPL couples where the female is of advanced maternal age have reported contradictory results. Hence, a multicentre randomised trial is needed to provide evidence for the clinical benefits of PGS2.0 treatment for RPL couples.

Methods and analysis Overall, 268 RPL couples undergoing IVF cycles will be enrolled. Couples will be randomised according to a unique grouping number generated by a random digital software into (1) PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation) group. This study aims to investigate whether the live birth rate (LBR) per initiated cycle after PGS2.0 is superior to the LBR per initiated cycle after conventional embryo evaluation (non-PGS group). Live birth will be defined as a live baby born after a gestation period of >28 weeks, with a birth weight of more than 1000 g. A multivariate logistic regression model will be used to adjust for confounding factors.

Ethics and dissemination Ethical approval has been granted by the Ethics Committee of Obstetrics and Gynecology Hospital, Fudan University and the participating hospitals. Written informed consent will be obtained from each couple before any study procedure is performed. Data from this study will be stored in the Research Electronic Data Capture. The results of this trial will be presented and published via peer-reviewed publications and presentations at international conferences.

Trial registration number NCT03214185; Pre-results.

  • prenatal diagnosis
  • reproductive medicine
  • antenatal

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  • Contributors CLei, YSui and XSun from the sponsor hospital designed the whole study. XSun was responsible for the whole project. CLei, XSun, YSun and LJin were responsible for patient recruitment and randomisation. CLei, YLu, JXi and JYe formed the data management team responsible for collecting and analysing all data. CLei, JYe, XSun, YSun and LJin supervised the data. The manuscript was drafted by CLei. All authors participated in reviewing, curating and the approval of the final manuscript.

  • Funding This work was funded by Shanghai Shen Kang Hospital Development Centre Municipal Hospital New Frontier Technology Joint Project (SHDC12017105). The study was sponsored by Obstetrics and Gynecology Hospital of Fudan University.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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