Maureen Porter1, Siladitya Bhattacharya. 1. Department of Obstetrics and Gynaecology, University of Aberdeen, Foresterhill, UK. m.a.porter@abdn.ac.uk
Abstract
BACKGROUND: In the context of mounting concern about the risks of twin pregnancies resulting from IVF, this study aimed to assess staff and patients' attitudes towards a proposed randomized controlled trial (RCT) of elective single embryo transfer (SET) in a Scottish fertility centre. METHODS: The views of 10 members of IVF clinic staff were assessed by means of a focus group and those of 12 couples by semi-structured interviews. RESULTS: Staff were aware of the risks of twin pregnancies to mothers and babies and the need for evidence of success in SET, but had reservations about the proposed RCT. The need to subject patients to unpopular scientific procedures such as randomization and blinding conflicted with their perceived caring role. They felt it would be hard to recruit and onerous to patients but nevertheless discussed how it could be successfully mounted if necessary. They debated how to ensure that consent was fully informed, and when, and how, to randomize. Patients accepted the possibility of twins but were largely unaware of risks inherent in twin pregnancies. They saw no need for a trial and found the idea of randomization unacceptable except in younger women. They would accept SET if it became unit policy and appeared unaffected by financial considerations. CONCLUSIONS: Involving affected staff at the design stage may make it easier to conduct a SET trial in their clinics. IVF patients whose ultimate goal is pregnancy are less likely to support a trial which aims to minimize twin pregnancies.
RCT Entities:
BACKGROUND: In the context of mounting concern about the risks of twin pregnancies resulting from IVF, this study aimed to assess staff and patients' attitudes towards a proposed randomized controlled trial (RCT) of elective single embryo transfer (SET) in a Scottish fertility centre. METHODS: The views of 10 members of IVF clinic staff were assessed by means of a focus group and those of 12 couples by semi-structured interviews. RESULTS: Staff were aware of the risks of twin pregnancies to mothers and babies and the need for evidence of success in SET, but had reservations about the proposed RCT. The need to subject patients to unpopular scientific procedures such as randomization and blinding conflicted with their perceived caring role. They felt it would be hard to recruit and onerous to patients but nevertheless discussed how it could be successfully mounted if necessary. They debated how to ensure that consent was fully informed, and when, and how, to randomize. Patients accepted the possibility of twins but were largely unaware of risks inherent in twin pregnancies. They saw no need for a trial and found the idea of randomization unacceptable except in younger women. They would accept SET if it became unit policy and appeared unaffected by financial considerations. CONCLUSIONS: Involving affected staff at the design stage may make it easier to conduct a SET trial in their clinics. IVFpatients whose ultimate goal is pregnancy are less likely to support a trial which aims to minimize twin pregnancies.
Authors: D J McLernon; K Harrild; C Bergh; M J Davies; D de Neubourg; J C M Dumoulin; J Gerris; J A M Kremer; H Martikainen; B W Mol; R J Norman; A Thurin-Kjellberg; A Tiitinen; A P A van Montfoort; A M van Peperstraten; E Van Royen; S Bhattacharya Journal: BMJ Date: 2010-12-21
Authors: Ricardo L R Baruffi; Ana L Mauri; Claudia G Petersen; Andréia Nicoletti; Anagloria Pontes; João Batista A Oliveira; José G Franco Journal: Reprod Biol Endocrinol Date: 2009-04-23 Impact factor: 5.211