Prolonged Effects of Assisted reproductive technologies on the health of women and their children: a Record Linkage study for England (PEARL)

Study type
Protocol
Date of Approval
Study reference ID
16_215
Lay Summary

In general, most children born after the use of fertility treatment (such as IVF) are healthy. However, there is a small increase in the number of children who are born early, have a low birthweight, and who have health or developmental problems. We know less about the health of children born after fertility treatment as they grow up, as long-term follow-up studies are costly and time consuming. As a result, many studies are not big enough to detect small differences between the groups – which is important because the effects of fertility treatment on health may be subtle. We also need more evidence about the long term health of women who have had fertility treatment.

PEARL is a large study of women and children in England. The study has three main aims; these are:
1. To find out the effect of fertility problems and fertility treatment on the health and development of children from birth to adolescence
2. To look at the impact of successful fertility treatment on the health and wellbeing of women
3. To estimate the additional costs to the NHS (if any) of caring for women and their children after successful fertility treatment
The PEARL study links routinely collected health information from the people included in the CPRD, to information collected about all fertility treatment cycles in England since 1991.

Technical Summary

The PEARL study is an observational epidemiological study using a retrospective cohort design. PEARL links health data (from the Mother-Baby track of CPRD GOLD), to information collected about all assisted reproductive technology (ART) cycles in England (from the Human Fertilisation and Embryology Authority Register). These data will be used to assess the effect of subfertility, ovulation induction and ART on the health and development of children to adolescence, and the wellbeing of infertile mothers. In addition, we will quantify the additional resources, if any, used by women and their children after successful ART. Methodological work to assess the impact of low consent rates after September 2009, on the results of ART studies conducted using the HFEA register, and explore techniques to deal with the effects of the missing data will also be conducted. Mother-baby pairs will be grouped depending on their exposure to ART, based on both primary care and HFEA records, and outcomes will be compared in those children born with and without the use of ART, and their mothers. Multivariable regression analysis will be used, and the role of confounders and effect modifiers in explaining any observed effects between exposure and outcomes will be explored.

Health Outcomes to be Measured

Children's health: Neurological and Developmental outcomes: Autism, developmental delay, special educational needs; Asthma and respiratory health; Congenital anomalies; Childhood illnesses and Infections; CPRD data relating to schooling and behaviour. Mother's health: Mental health - including Postnatal depression; Depression; Anxiety; Long-term Economic costs of ART: Use of health services; Costs associated with subsequent NHS care of women, and their children.

Collaborators

Claire Carson - Chief Investigator - University of Oxford
Claire Carson - Corresponding Applicant - University of Oxford
Aden Kwok - Collaborator - University of Oxford
Brooke Hewitson - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Jenny Kurinczuk - Collaborator - University of Oxford
Maria A Quigley - Collaborator - University of Oxford
Oliver Rivero-Arias - Collaborator - University of Oxford
Xinyang Hua - Collaborator - University of Melbourne
Yangmei Li - Collaborator - University of Oxford

Former Collaborators

Sarah Lay-Flurrie - Collaborator - University of Oxford

Linkages

CPRD Mother-Baby Link;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation;Other