Download Society for Assisted Reproductive Technology

Types of Regulation
• State Regulation: Medical licensing
• Federal Regulation: CDC, FDA, CMS/CLIA
• Professional Self-Regulation: CAP, SART
Federal Regulation
• Center for Disease Control (CDC): Complete
annual reporting
• Food and Drug Administration (FDA): Screening
and testing of reproductive tissues, patient
testing
• Centers for Medicare and Medicaid Services/
Clinical Laboratory Improvement Act(CMS/CLIA):
Ensure quality lab testing
Self-Regulation
• College of American Pathologists (CAP)onsite/self-inspection, proficiency testing
• American Society for Reproductive Medicine
(ASRM)- ethical guidelines
• Society for Assisted Reproductive Technology
(SART)- affiliate of ASRM involved in cycle
reporting
Society for Assisted Reproductive
Technology
• 393 practices, >90% clinics in US
• What does SART do?
– Data collection
– Practice guidelines and standards
– Government interaction
– Quality assurance
– Research
SART Reporting
• Patient Health History: age, height, weight,
gravidity, known diagnoses, previous ART treatments
• Current ART Treatment Information: types of
medication/stimulation, complications
• Cycle Information: retrieval details, andrology,
micromanipulation and fertilization
• Transfer and Outcome: Embryo morphology, number
transferred, cryopreservation, treatment outcome
• Delivery: Pregnancy outcome, delivery date, number born,
weight, gender, birth defects
Treatment Outcome
• Not Pregnant
• Biochemical: positive hCG by blood test
• Clinical Intrauterine Gestation: one or more
gestational sacs confirmed by ultrasound
• Ectopic pregnancy: gestational sac outside of uterine
cavity
• Heterotopic: clinical intrauterine gestation and ectopic
pregnancy
• Unknown
55%
50%
67%
67%
50%
17%
56%
59%
100%
100%
20%
20%
10%
37%
2
20%
0%
33%
60%
2.5
50%
0%
17%
27%
2.2
0%
0%