Increased obstetric and neonatal risks in artificial cycles for frozen embryo transfers?
ANTARCTICA trial study group
(2021) Reproductive Biomedicine Online, volume 42, issue 5, pp. 919 - 929
(Article)
Abstract
RESEARCH QUESTION: What are the obstetric and neonatal risks for women conceiving via frozen-thawed embryo transfer (FET) during a modified natural cycle compared with an artificial cycle method. DESIGN: A follow-up study to the ANTARCTICA randomized controlled trial (RCT) (NTR 1586) conducted in the Netherlands, which showed that modified natural
... read more
cycle FET (NC-FET) was non-inferior to artificial cycle FET (AC-FET) in terms of live birth rates. The current study collected data on obstetric and neonatal outcomes of 98 women who had a singleton live birth. The main outcome was birthweight; additional outcomes included hypertensive disorder of pregnancy, premature birth, gestational diabetes, obstetric haemorrhage and neonatal outcomes including Apgar scores and admission to the neonatal ward or the neonatal intensive care unit and congenital anomalies. RESULTS: Data from 82 out of 98 women were analysed according to the per protocol principle. There was no significant difference in the birthweights of children born between groups (mean difference -124 g [-363 g to 114 g]; P = 0.30). Women who conceived by modified NC-FET have a decreased risk of hypertensive disorders of pregnancy compared with AC-FET (relative risk 0.27; 95% CI 0.08-0.94; P = 0.031). Other outcomes, such as rates of premature birth, gestational diabetes or obstetric haemorrhage and neonatal outcomes, were not significantly different. CONCLUSIONS: The interpretation is that modified NC-FET is the preferred treatment in women with ovulatory cycles undergoing FET when the increased risk of obstetrical complications and potential neonatal complications in AC-FET are considered.
show less
Download/Full Text
Keywords: Artificial cycle, Birthweight, Frozen–thawed embryo transfer, Hypertensive disorders of pregnancy, Natural cycle, Safety, Obstetrics and Gynaecology, Reproductive Medicine, Developmental Biology, Journal Article
ISSN: 1472-6483
Publisher: Elsevier
Note: Funding Information: This study was funded by ZonMW (award number 843002807). We thank all the women (and their partners) who participated in the trial and follow-up study, the hospitals and their staff, and the research nurses and staff of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology for logistic support. We thank Dr Wessel Ganzevoort for his advice and contribution during the final phase of this manuscript. We would like to thank Willem JJ van Enk of Sorg-Saem for support during the collection of Astraia data for CRL measurements. The ANTARTICA trial study group consists of: Myrthe L Bandell, Albert Schweitzer Hospital, Department of Obstetrics and Gynecology, Zwijndrecht, the Netherlands; Egbert A Brinkhuis, Meander Medical Center, Department of Obstetrics and Gynecology, Amersfoort, the Netherlands; Kathrin Fleisher, University Medical Center Nijmegen, Department of Obstetrics and Gynecology, Nijmegen, the Netherlands; Annemieke Hoek, Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, the Netherlands; Diederik A Hoozemans, Medisch Spectrum Twente, Department of Obstetrics and Gynecology, Enschede, the Netherlands; Eugenie M Kaaijk, Onze Lieve Vrouwe Gasthuis, Department of Obstetrics and Gynecology, Amsterdam, the Netherlands; Carolina AM Koks, Máxima Medical Center, Department of Obstetrics and Gynecology, Veldhoven, the Netherlands; Esther B Baart, Department of Obstetrics and Gynecology, Erasmus Medical Center Rotterdam, the Netherlands; Paul JQ van der Linden, Deventer Hospital, Department of Obstetrics and Gynecology, Deventer, the Netherlands; Petra A Manger, Diakonessenhuis, Department of Obstetrics and Gynecology, Utrecht, the Netherlands; Minouche ME van Rumste, Catharina Hospital, Department of Obstetrics and Gynecology, Eindhoven, the Netherlands; Taeke Spinder, Medisch Centrum Leeuwarden, Department of Obstetrics and Gynecology, Leeuwarden, the Netherlands; Jantien Visser, Amphia Hospital, Department of Obstetrics and Gynecology, Breda, the Netherlands. TZ was supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMW 843002807) in order to perform the Antarctica-2 RCT (trial NL6414, NTR6590). JPB received unconditional educational grants from Merck Serono and Ferring, and is a member of the medical advisory board of Ferring. FB reports personal fees from being a member of the external advisory board for Ferring BV and Merck Serono, the Netherlands, and from Gedeon Richter, Belgium; personal fees from educational activities for Ferring BV, the Netherlands, research support grants from Ferring BV and Merck Serono, and personal fees from advisory and consultancy work for Roche, outside the submitted work. BC reports that the Isala Fertility Centre received research grants from Ferring and Merck. MG works at the Department of Reproductive Medicine of the Amsterdam UMC (Location AMC and Location VUMC). Location VUMC has received several research and educational grants from Guerbet, Merck and Ferring. These grants are not related to the presented work. NM reports receiving monetary compensations for external advisory and speaking work for Ferring BV, MSD, Anecova and Merck Serono during the conduct of the ANTARCTICA RCT. EG received personal fees from Titus Health Care outside the submitted work. During the conduct of the ANTARCTICA RCT EG received an education grant from MSD. MSD had no influence on the design, execution or analyses of this study. All reported competing interests are outside the submitted work. No other relationships or activities appear to have influenced the submitted work. The remaining authors have no conflicts of interest to declare. Funding Information: FB reports personal fees from being a member of the external advisory board for Ferring BV and Merck Serono, the Netherlands, and from Gedeon Richter, Belgium; personal fees from educational activities for Ferring BV, the Netherlands, research support grants from Ferring BV and Merck Serono, and personal fees from advisory and consultancy work for Roche, outside the submitted work. Funding Information: This study was funded by ZonMW (award number 843002807). Funding Information: TZ was supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMW 843002807) in order to perform the Antarctica-2 RCT (trial NL6414, NTR6590). Publisher Copyright: © 2021 The Authors
(Peer reviewed)
