The Human Fertilisation and Embryology Act of the United Kingdom was passed
in 1990, leading to the formation of the Human Fertilisation and Embryology
Authority (HFEA), the first statutory body to regulate and control assisted
conception anywhere in the world. The principal function of the HFEA is to
license and monitor clinics that carry out in vitro fertilization (IVF), donor
insemination (DI), and embryo research. Information on over 135,000 treatment
cycles, 20,000 pregnancies, and 25,000 babies following IVF has now been
collected as part of the regulatory process, and these data have permitted
unbiased and accurate evaluation of treatment efficacy using pregnancy and
live-birth rates. The treating clinics are required by law to provide
information on the outcome of all births, including neonatal mortality and
congenital malformations, but there is no systematic validation of these data
using medical records or any follow-up of treated women, or babies, over time.
In addition, the strict confidentiality of data supplied to the HFEA means
that outside researchers have been unable to access the database for research
projects. Thus, at the present time, it is not possible to evaluate the
long-term safety of assisted conception procedures using HFEA data. There is
reasonable scientific evidence to justify full investigation of the health of
both treated women and resulting children. Particular health outcomes
requiring evaluation include obstetric complications, preterm births, cerebral
palsy, and cancer. The HFEA has recognized the need for follow-up studies and
is currently investigating ways of enabling research projects using HFEA data
to be undertaken.