UppStART

Recruitment took place from September 2011 to December 2013. IVF treatment(s) of the participants were followed until December 2014. At the time of planning their first IVF/ICSI treatment, couples were approached by the clinic´s nurse or midwife and asked to participate in the study. The requirement for inclusion in the study was an understanding of the Swedish language and exclusion was the use of donor gametes. After informed consent was given, the clinic staff withdrew blood samples and provided the participant with a kit for at-home saliva collection. The participants were asked to answer a web-based baseline questionnaire within a few days of their clinic visit and prior to their IVF/ICSI treatment start, which included an extensive list of questions on sociodemographic, anthropometric and life-style factors. When the couples returned to the clinic for repeated ART attempts, clinic staff collected a blood sample, provided saliva collection tubes, and instructed the participants to respond to the online follow-up questionnaire. Biological samples were also collected from participants during delivery (cord blood, maternal blood, placenta).

The UppStART study was initiated to:

1) investigate if epigenetic alterations exist in infants conceived via ART compared to those conceived spontaneously;

2) investigate if lifestyle factors (e.g. caffeine consumption, cortisol levels, folate, C-reactive protein, natural products and supplements, and prescribed medication use) are associated with time to pregnancy, pregnancy rates, subclinical and clinically recognized miscarriages, ART procedure specific outcomes (e.g. number and quality of oocytes and embryos, sperm characteristics), and obstetric and prenatal outcomes in ART cycles and pregnancies.

The UppStART study was funded by the EU-FP7 Health program (IDEAL, agreement 259679), the Swedish Research Council (K2011-69X-21871-01-6 and SIMSAM 340-2013-5867) and the Strategic Research Program in Epidemiology Young Scholar Awards, Karolinska Institutet.

The study has been approved by the regional ethics review board at Karolinska Institutet (Dnr 2011/230-31/1, 2011/1427-32, 2012/131-32, 2012/792-32, 2013/1700-32, 2014/1956-32, 2015/1604-32).

For researchers

We encourage the use of UppStART study data as a resource for epidemiological research. To access the data, a proposal should be submitted to the principal investigators by an applicant with a PhD or an equivalent degree. Proposals will be evaluated and granted according to principles of ethical and scientific soundness. Applicants based outside of Sweden are required to involve collaborator(s) based at a Swedish research institution. Applications can only be granted and data provided after approval by the Stockholm Ethical Review Board. For information and instructions for applicants contact Carolyn Cesta.