Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial

Caixia Lei; Yilun Sui; Jiangfeng Ye; Yao Lu; Ji Xi; Yun Sun; Li Jin; Xiaoxi Sun

doi:10.1136/bmjopen-2019-036252

Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial

BMJ Open. 2020 Oct 7;10(10):e036252. doi: 10.1136/bmjopen-2019-036252.

Authors

Caixia Lei^{1

2}, Yilun Sui², Jiangfeng Ye³, Yao Lu⁴, Ji Xi⁵, Yun Sun⁴, Li Jin⁵, Xiaoxi Sun^{6

7}

Affiliations

¹ Prenatal Diagnosis Center, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
² Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China.
³ Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
⁴ Reproductive Medical Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
⁵ Reproductive Medical Center, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
⁶ Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China [email protected].
⁷ Key Laboratory of Female Reproductive Endocrine Related Diseases, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.

Abstract

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.

Keywords: antenatal; prenatal diagnosis; reproductive medicine.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Abortion, Habitual*
Birth Rate
Female
Fertilization in Vitro
Genetic Testing
Humans
Multicenter Studies as Topic
Pregnancy
Preimplantation Diagnosis*
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT03214185