» Articles » PMID: 33033011

Comparison of PGS2.0 Versus Conventional Embryo Morphology Evaluation for Patients with Recurrent Pregnancy Loss: a Study Protocol for a Multicentre Randomised Trial

Overview
Journal BMJ Open
Specialty General Medicine
Date 2020 Oct 9
PMID 33033011
Citations 5
Authors
Affiliations
Soon will be listed here.
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 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.

Citing Articles

Reproductive outcomes after preimplantation genetic testing in couples with sex chromosome abnormalities: a retrospective cohort study of 83 couples.

Yang T, Xiao M, Sun X, Li H J Assist Reprod Genet. 2024; 41(12):3415-3421.

PMID: 39476305 PMC: 11707093. DOI: 10.1007/s10815-024-03303-6.


Growth hormone supplementation during ovarian stimulation in women with advanced maternal age undergoing preimplantation genetic testing for Aneuploidy.

Sui Y, Xiao M, Fu J, Li L, Xu Y, Lei C J Ovarian Res. 2023; 16(1):204.

PMID: 37858247 PMC: 10585718. DOI: 10.1186/s13048-023-01279-y.


Recent Advances in Treatment of Recurrent Spontaneous Abortion.

Deng T, Liao X, Zhu S Obstet Gynecol Surv. 2022; 77(6):355-366.

PMID: 35672876 PMC: 9169761. DOI: 10.1097/OGX.0000000000001033.


Re-denudation of residual cumulus cells on day 3 increases the accuracy of cell-free DNA detection in spent embryo culture medium.

Lei C, Fu J, Li X, Zhou J, Xiao M, Zhang S J Assist Reprod Genet. 2022; 39(7):1653-1660.

PMID: 35672538 PMC: 9365923. DOI: 10.1007/s10815-022-02511-2.


Genetic Testing for Aneuploidy in Patients Who Have Had Multiple Miscarriages: A Review of Current Literature.

Papas R, Kutteh W Appl Clin Genet. 2021; 14:321-329.

PMID: 34326658 PMC: 8315809. DOI: 10.2147/TACG.S320778.

References
1.
Fu J, Shao J, Li X, Xu Y, Liu S, Sun X . Non-invasive metabolomic profiling of day 3 embryo culture media using near-infrared spectroscopy to assess the development potential of embryos. Acta Biochim Biophys Sin (Shanghai). 2013; 45(12):1074-8. DOI: 10.1093/abbs/gmt115. View

2.
Vinals Gonzalez X, Odia R, Naja R, Serhal P, Saab W, Seshadri S . Euploid blastocysts implant irrespective of their morphology after NGS-(PGT-A) testing in advanced maternal age patients. J Assist Reprod Genet. 2019; 36(8):1623-1629. PMC: 6707991. DOI: 10.1007/s10815-019-01496-9. View

3.
Wu Q, Li H, Zhu Y, Jiang W, Lu J, Wei D . Dosage of exogenous gonadotropins is not associated with blastocyst aneuploidy or live-birth rates in PGS cycles in Chinese women. Hum Reprod. 2018; 33(10):1875-1882. DOI: 10.1093/humrep/dey270. View

4.
. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2012; 99(1):63. DOI: 10.1016/j.fertnstert.2012.09.023. View

5.
Rottenstreich A, Amsalem H, Kleinstern G, Kalish Y . Outcomes of threatened abortions after anticoagulation treatment to prevent recurrent pregnancy loss. Reprod Biomed Online. 2017; 35(4):461-467. DOI: 10.1016/j.rbmo.2017.06.018. View