ART Data Monitoring

Last updated: 23 May 2013

South African Register of Assisted Reproductive Techniques (SARA) Committee

Preamble: The growing impact of ART on human reproduction globally has been paralleled by a call for data on the efficacy and safety of these techniques. Information on treatment outcome and safety is relevant to many stakeholders including patients, the general public, health care planners and funders, and ART units themselves. Relevant information cannot be extrapolated from research trials but requires a data registry. To date, efficacy and safety data are collected at national, regional and global level, and regional and world reports are published annually. Until recently sub-Saharan Africa was the only region in which no country monitored ART and hence no data were collected. In order to close the information gap in South Africa, the South African Society of Reproductive Medicine and Gynaecological Endoscopy (SASREG) established a sub-committee in 2007 with the objective to establish voluntary, national, anonymous ART data monitoring. The committee has achieved its objective with a 1st and 2nd report, comprising data from 2009 and 2010, having been generated, distributed and published. The necessary documentation for a functional data register was initially drawn up as required. Formal terms of references were drafted in September 2012 and adopted by the SASREG committee 12.2.2013.

Committee Name: The Committee is known as the SARA Committee. SARA is the acronym for South African Register of Assisted Reproductive Techniques. The committee is constituted by the Committee Chair, the SASREG President, the SARA embryologist and the SARA Administrator. Additional committee members may be co-opted particularly with the view of ensuring regional/provincial representation of ART Units.

Goals of the sub-committee on national anonymous ART data monitoring:

  1. Primary goal: to collect and disseminate national data on the results of ART performed in South Africa
  2. Secondary goal: to make ART monitoring part of accreditation of ART centres by SASREG
  3. Tertiary goal: to generate a robust data base for the monitoring of trends in ART, future epidemiological studies and as external quality control for individual centres


    1. An annual report on ART procedures performed in South Africa
    2. Dissemination of the SASREG approved report to stakeholders
    3. A functional process for data monitoring
    4. Award of annual certificates of SARA membership to participating centres
    5. Review and revision of type of data collected in order to meet local, regional and international needs and standards related to ART monitoring
    6. Provide the SASREG committee with input regarding ART monitoring as part of accreditation of ART units by SASREG
    7. Assistance and education to individual ART centres regarding ART monitoring
    8. Participation in regional and global ART data monitoring

Research and Ethics Committee registration

SARA is registered with the Human Research Ethics Committee of the Faculty of Health Sciences, University of Cape Town (Ref.number R005/2012; expiry date 30.10.2015).

Any research using the SARA data base requires a protocol, approval by the SASREG and SARA committee, and approval by the HREC with which SARA is registered. This requirement does however not apply to the annual standard generation and dissemination of SARA data.

Process of ART data monitoring:

The chair of the SARA committee issues an annual call for data to all known ART units in South Africa. The submission of data to SARA by individual ART centres is voluntary. Participating units submit annual data to the SARA Administrator in a format provided by SARA and within stipulated timelines and following the signing of a Memorandum of Understanding.

Submitted data is received by the SARA Administrator, who is a member of the SARA/SASREG secretariat, as represented by Turners Conferences, and who is approved by the SARA Committee and ratified by the SASREG Committee. The SARA Administrator checks the data for internal consistency. The SARA Administrator certifies that the submitted data will be kept confidential and never be disclosed to patients, government or any other parties.

Only internally consistent data is accepted. All identifying information is removed from accepted data prior to entry into the SARA database.

Neither the SARA chair nor any member of the SARA committee has access to any identifying information relating to the data of an individual ART centre. Only summary data, that is pooled data from all participating units/laboratories, is analysed and reported. All participating units/laboratories are acknowledged in the annual report of SARA.

Participating units give the SARA committee the right to publish and disseminate information from SARA in such manner as approved by the committee of SASREG but always subject to the anonymity and confidentiality conditions.

Benefits of national anonymous ART data monitoring

A national anonymous ART data register has several benefits which include:
  • Relevant data on ART coverage. An annual report of the collective number of ART cycles conducted by all participating clinics is an important indication of availability and access to ART in South Africa. It helps to determine to what extend the need for ART treatment, which is estimated at 1500 ART cycles/million people/annum, is being met.
  • Relevant data on the efficacy and safety of ART treatment. Annual outcome measures include, among others, national mean pregnancy rate per oocyte aspiration or embryo transfer and age-related pregnancy rates. In the near future information on multiple pregnancy rates and the occurrence of complications such as severe ovarian hyperstimulation syndrome, will also be collected. These outcome measures allow patients, health care funders and health care providers to evaluate the costs and benefits of ART treatment and to make comparisons with different therapeutic options. The data is also relevant to other stakeholders such as the industry and the media.
  • Furthering trust and acceptance from the public into techniques that are sometimes at risk of being perceived as 'unnatural', 'dangerous', 'unregulated' or 'unpredictable'.
  • The ability to determine trends over time and to react appropriately.
  • Participation in the global monitoring of ART and in international comparisons relating to ART access and practice.
  • Improving the quality of infertility care in South Africa. Experience has demonstrated that the implementation of national or regional ART data monitoring is associated with improved quality of ART. Moreover, individual clinics/laboratories have an important external quality control measure against which to evaluate their own performance data.

Limitations of national anonymous ART data monitoring

The success of the register is dependent on the voluntary participation of ART clinics and on the reliability of data submitted by each participating centre. There is however no perceivable advantage in the submission of falsified data since all data will be anonymized and pooled. To date the voluntary participation has been excellent with 14 centres contributing data to the 2010 report.

National ART data monitoring is not a substitute for sound clinical or laboratory research, although it may assist in ART-related research. Answers to the question, for example, 'What is the optimal stimulation protocol for ART?' must be derived from randomized controlled trials not from national data registries.

International interest and support

SARA has received support and interest from various official bodies. We wish to acknowledge:
  • The office of the Latin American Register of Assisted Reproduction (RLA) which is part of the Latin American Network of Assisted Reproduction (REDLARA). Represented by Dr Fernando Zegers-Hochschild the RLA has provided invaluable expertise and support. The RLA generously agreed to make their software programme available to South Africa and to modify it according to our local needs. As a result we do not only have their expert input, but the advantage of a single software programme capturing data in South America, South Africa and - hopefully in the future - sub-Saharan Africa.
  • The International Committee for Monitoring Assisted Reproductive Technology (ICMART), the International Federation of Fertility Societies (IFFS) and the World Health Organisation (WHO). Representatives of these organisations have shown a keen interest in the implementation of national anonymous ART data monitoring in South Africa and have provided expert advice on several occasions.