Health in mothers and children after assisted reproductive technology - Committee of Nordic ART and Safety (CoNARTaS)
| ISRCTN | ISRCTN11780826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11780826 |
| Secondary identifying numbers | 706005 |
- Submission date
- 23/10/2018
- Registration date
- 28/12/2018
- Last edited
- 07/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
More than 7 million children have been born after assisted reproductive technology (ART) since the first baby was born after ART in 1978. The significant decrease in twin births has caused a tremendous drop in the twin birth rates and the associated preterm birth rate. However, single births conceived by ART also have a slightly higher risk of adverse outcomes depending on the ART technology used. The aim of this study is to assess the short- and long-term health risks in children conceived after ART.
Who can participate?
Women who delivered after ART treatment and children born after ART conception in 1985-2015 in Sweden, Norway, Denmark and Finland, and women delivering after spontaneous conception during the same time period and their children
What does the study involve?
This study only includes only register data that are routinely recorded in all private and public clinics in Denmark. This data recording is compulsory and there is no other involvement for the patients. The main categories of data are type of ART treatment, pregnancy and perinatal outcomes, selected diagnosis from specialised health care including detailed information on malignancies, diabetes, imprinting diseases, cardiovascular diseases, neurodevelopmental health and school performance and causes of death.
What are the possible benefits and risks of participating?
Possible benefits are the new knowledge obtained, which may lead to altering or abandoning certain ART methods such as freezing and lead to more safe ART treatments. Further if increased long-term health risks are seen in ART children screening programs may be set up for the patients to prevent further disease development. There are no risks for patients related to the trial.
Where is the study run from?
1. Fertility Clinic, Rigshospitalet (Denmark)
2. National Institute for Health and Welfare (Finland)
3. Hvidovre Hospital (Denmark)
4. Helsinki University Hospital (Finland)
5. Sahlgrenska University Hospital, Inst of Clinical Sciences, University of Gothenburg (Sweden)
6. Norwegian University of Science and Technology (NTNU) (Norway)
When is the study starting and how long is it expected to run for?
October 2016 to October 2028
Who is funding the study?
1. NordForsk
2. Sahlgrenska Universitetssjukhuset
3. NFOG fund
4. Reprounion EU/Interreg
5. The Research Fund of Helsinki University Hospital
6. Kreftforeningen
7. Helse Midt-Norge
8. Norges Teknisk-Naturvitenskapelige Universitet
Who is the main contact?
Prof. Anja Pinborg
Contact information
Scientific
Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
Blegdamsvej 9
Copenhagen
2100
Denmark
 ORCID ID |
0000-0002-8340-104X |
|---|
Study information
| Study design | Nordic controlled register-based cohort study including all children born after assisted reproductive technology and their mothers in Finland, Norway, Sweden and Denmark from 1985 to 2015. Control groups comprise the national birth cohorts born during the same period in the four Nordic countries, as well as their mothers. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | Health in mothers and children after assisted reproductive technology - Committee of Nordic ART and Safety (CoNARTaS) |
| Study acronym | CoNARTaS |
| Study objectives | Short- and long-term health in children conceived by assisted reproductive technology and in their mothers differs from health in children and mothers after spontaneous conception. Specific ART methods influence short and long-term health in children and mothers differently and give rise to altered health risk profiles. |
| Ethics approval(s) | Approvals for data retrieval and linkage were obtained in each country. In Denmark and Finland, ethical approval is not required for research solely based on registry data. In Norway, ethical approval was given by the Regional Committee for Medical and Health Research Ethics (REC North, 2010/1909-13-20, 05/09/2016). In Sweden approval was obtained from the Ethical committee in Gothenburg, Dnr 214-12 (22/05/2012), T422-12, T516-15, T233-16, T300-17, T1144-17, T121-18. |
| Health condition(s) or problem(s) studied | Reproductive medicine, infertility Morbidity, cognitive development, and mortality in mothers and children after assisted reproductive technology treatment |
| Intervention | The cohort consists of 173,148 children conceived by ART and their mothers, identified from the Medical Birth Registries in Denmark (1994 to 2015), Finland (October 1992 to 2015), Norway (1984 to 2015) and Sweden (1985 to 2015). The control cohorts are the background populations of children born during the same time periods in the four countries and their mothers. Data are individual-level data on all residents that are routinely collected by the national health and socio-economic registries in each country and may be linked using the unique personal identity number of each resident. Main categories of data are on type of ART treatment herein IVF, ICSI, frozen embryo transfer and oocyte donation, pregnancy and perinatal outcomes, selected diagnosis from specialised health care including detailed information on malignancies, diabetes, imprinting diseases, cardiovascular diseases, neurodevelopmental health and school performance and causes of death are available for all individuals in the cohort. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Short and long-term health in children born after ART (perinatal outcomes, imprinting diseases, diabetes, pubertal diseases, malignancies, cardiovascular diseases, cognitive development, mental health, mortality) 2. Short and long-term health in women who give birth after ART (pregnancy complications, mental health, metabolic diseases, cardiovascular disease, cancer, mortality) Data are routinely collected by the national health and socio-economic registries in each country. Data are entered continuously in the database and the primary outcome will be measured at different child ages with the relevant statistical adjustments for this in the analyses. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2016 |
| Completion date | 01/10/2028 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 7,000,000 |
| Key inclusion criteria | 1. Women who delivered after ART treatment and children born after ART conception 1985-2015 in Sweden, Norway, Denmark and Finland 2. Control group: all mothers delivering after spontaneous conception during the same time period and their children |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/1985 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Denmark
- Finland
- Norway
- Sweden
Study participating centres
Copenhagen
2100
Denmark
Helsinki
FI-00271
Finland
Hvidovre
2650
Denmark
Helsinki
00029 HUS
Finland
Gothenburg
41685
Sweden
Trondheim
7030
Norway
Sponsor information
Hospital/treatment centre
Blegdamsvej 9
Copenhagen
2100
Denmark
| Website | https://www.rigshospitalet.dk/afdelinger-og-klinikker/julianemarie/fertilitetsklinikken/Sider/default.aspx |
|---|---|
"ROR" |
https://ror.org/03mchdq19 |
Funders
Funder type
Government
Government organisation / Local government
- Location
- Norway
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Sahlgrenska University Hospital, SU
- Location
- Sweden
No information available
No information available
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Norwegian Cancer Society, NCS
- Location
- Norway
Government organisation / Local government
- Alternative name(s)
- Central Norway Regional Health Authority
- Location
- Norway
Government organisation / Universities (academic only)
- Alternative name(s)
- Norwegian University of Science and Technology, The Norwegian University for Technology an Sciences, Universidad Noruega de Ciencia y Tecnología, NTNU
- Location
- Norway
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be published in peer-reviewed high ranking scientific journals and at Nordic and international scientific congresses. Thirteen scientific publications have already been published based on the Nordic cohort data up to 2007 primarily on short term health outcomes i.e. perinatal morbidity and mortality and malformations. The trialists are now planning another 10 to 15 publications on long-term health outcomes including also the children born after ART conception up to 2015. Results of general interest will be published in the lay press, broadcast, television and social media. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Anja Pinborg. As these are national health care data hosted in Statistics Denmark, data cannot be transported to other research institutions or hospitals.dk. Request for working with the database should be send to the investigator and the request will be brought up on the first coming CoNARTas board meeting. The board will look at each application individually. If approval is given the trialists will prepare a specific database for the purpose of the new study and researcher(s) will have login to Statistics Denmark with limited access to this specific role. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No | |
| Results article | results | 01/05/2014 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 01/07/2015 | Yes | No | |
| Results article | results | 01/10/2016 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/07/2018 | Yes | No | |
| Results article | results | 01/10/2018 | Yes | No | |
| Results article | results | 01/10/2018 | Yes | No | |
| Results article | results | 01/01/2019 | Yes | No | |
| Results article | results | 01/01/2020 | 27/01/2020 | Yes | No |
| Results article | results | 18/03/2021 | 11/01/2021 | Yes | No |
| Results article | 19/07/2021 | 01/06/2021 | Yes | No | |
| Results article | 25/06/2021 | 28/06/2021 | Yes | No | |
| Results article | 07/09/2021 | 08/09/2021 | Yes | No | |
| Results article | 01/09/2022 | 02/09/2022 | Yes | No | |
| Results article | 01/01/2025 | 07/01/2025 | Yes | No |
Editorial Notes
07/01/2025: Publication reference added.
02/09/2022: Publication reference added.
08/09/2021: Publication reference added.
28/06/2021: Publication reference added.
01/06/2021: Publication reference added.
11/01/2021: Publication reference added.
27/01/2020: Publication reference added.
