Data Elements Used for Calculations

Att C8a. Success rate calculations_07 13 2015.docx

Assisted Reproductive Technology (ART) Program Reporting System

Data Elements Used for Calculations

OMB: 0920-0556

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ATTACHMENT C8-a.


Overview of NASS Data Elements Used for Success Rates Calculations, and Publication Plan






Data to be Reported 1

Variable status 2

(add, drop, modify, unchanged)

Used in Success Rates Calculations 3

Other Significant Factors’ (FCSRCA) Affecting Success Rates 3

Dissemination and Publication Plan







1

Date of cycle reporting

Add

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

2

NASS Patient ID

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

3

Patient Optional Identifiers

Modify



Optional Field for Clinic Use

4

Date of Birth

(Patient)

Unchanged


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

5

Sex of patient seeking ART

Add


X

Supplemental Publications

6

Cycle start date

Modify

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

7

Patient US Resident

Modify


X

ART Surveillance Summary

Supplemental Publications

8

Patient Country of Residence (if not United States)

Unchanged


X

ART Surveillance Summary

Supplemental Publications

9

Patient State of Residence

Modify


X

ART Surveillance Summary

Supplemental Publications

10

Patient city of residence

Modify


X

ART Surveillance Summary

Supplemental Publications

11

Patient Zip Code of residence

Modify


X

ART Surveillance Summary

Supplemental Publications

12

Intended cycle type

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

13

Embryo or oocyte banking type

Modify

X

X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

14

Intended duration of oocyte banking

Add


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

15

Intended duration of embryo banking

Add


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

16

Intended embryo source

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

17

Intended Oocyte Source and state

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

18

Intended Sperm Source (Partner, Donor, Mixed)

Modify


X

ART National Summary Report

Supplemental Publications

19

Intended pregnancy carrier

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

20

Cycle type

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

21

Embryo source

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

22

Oocyte Source and state

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

23

Reason for ART

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

24

Female Patient Height

Unchanged


X

Supplemental Publications

25

Female Patient Weight at the start of this cycle

Unchanged


X

Supplemental Publications

26

History of cigarette smoking

Modify


X

Supplemental Publications

27

Prior pregnancy

Add


X

ART National Summary Report

Supplemental Publications

28

Months attempting pregnancy (if couple is not surgically sterile)

Add


X

Supplemental Publications

29

Female Patient Gravidity

Modify


X

ART National Summary Report

Supplemental Publications

30

Prior Full-Term Births

Unchanged


X

ART National Summary Report

Supplemental Publications

31

Prior Preterm Births

Unchanged


X

ART National Summary Report

Supplemental Publications

32

Number of Prior Stillbirths

Add


X

ART National Summary Report

Supplemental Publications

33

Prior Spontaneous Abortions

(miscarriage)

Unchanged


X

ART National Summary Report

Supplemental Publications

34

Prior ectopic pregnancies

Add


X

ART National Summary Report

Supplemental Publications

35

Prior stimulations for ART

Modify


X

ART National Summary Report

Supplemental Publications

36

Prior Frozen ART Cycles

Unchanged


X

ART National Summary Report

Supplemental Publications

37

Prior ART cycles resulted in pregnancy

Add


X

ART National Summary Report

Supplemental Publications

38

Female Patient Maximum Follicle Stimulating Hormone (FSH) Level

Modify


X

Supplemental Publications

39

Anti-Mullerian Hormone (AMH) level (ng/mL)

Add


X

Supplemental Publications

40

Date of Birth

(Oocyte source)

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

41

Oocyte source ethnicity

Modify


X

Supplemental Publications

42

Oocyte source race

Modify


X

Supplemental Publications

43

Pregnancy carrier

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

44

Pregnancy carrier date of birth

Modify


X

Supplemental Publications

45

Pregnancy carrier Ethnicity

Modify


X

Supplemental Publications

46

Pregnancy carrier Race

Modify


X

Supplemental Publications

47

Sperm source

Modify


X

ART National Summary Report

Supplemental Publications

48

Sperm source date of birth

Add


X

Supplemental Publications

49

Sperm source Ethnicity

Add


X

Supplemental Publications

50

Sperm source Race

Add


X

Supplemental Publications

51

Medications given to stimulate follicular development

Unchanged


X

ART Clinic Success Rates Report

Supplemental Publications

52

Oral medications given

Modify


X

Supplemental Publications

53

Medications containing FSH

Modify


X

Supplemental Publications

54

Medications with LH/HCG activity

Add


X

Supplemental Publications

55

GnRH Protocol

Modify


X

Supplemental Publications

56

Cycle cancelled before retrieval

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

57

Date of Cancellation

Unchanged


X

Supplemental Publications

58

Reason for Cancel

Modify


X

ART National Summary Report

Supplemental Publications

59

Date of Oocyte Retrieval

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

60

Number of Patient Oocytes Retrieved

Unchanged


X

Supplemental Publications

61

Number of Donor Oocytes Retrieved

Unchanged


X

Supplemental Publications

62

Use of retrieved oocytes

Modify


X

ART Clinic Success Rates Report

Supplemental Publications

63

Number of Fresh Oocytes Cryopreserved

Unchanged


X

ART National Summary Report

Supplemental Publications

64

Complications of stimulation or retrieval

Add


X

Supplemental Publications

65

Type of complications related to ovarian stimulation or oocyte retrieval

Modify


X

Supplemental Publications

66

Hospitalization for Complication

Modify


X

Supplemental Publications

67

Sperm State

Add


X

Supplemental Publications

68

Sperm Collection Method (Ejaculation, Epididymal Aspiration, Testicular Biopsy, Electroejaculation, Retrograde Ejaculation)

Modify


X

Supplemental Publications

69

Use of Intracytoplasmic Sperm Injection

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

70

Indication for ICSI

Add


X

ART National Summary Report

Supplemental Publications

71

In vitro maturation used?

Modify


X

ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

72

PGD or PGS performed on embryos

Unchanged


X

ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

73

Total 2PN

Add


X

Supplemental Publications

74

Pre-implantation genetic diagnosis (PGD) or screening (PGS) reason

Modify


X

Supplemental Publications

75

Pre-implantation genetic diagnosis or screening technique

Add


X

Supplemental Publications

76

Use of Assisted Hatching

Modify


X

ART National Summary Report

Supplemental Publications

77

Research cycle

Add


X

ART Clinic Success Rates Report

ART National Summary Report

ART Surveillance Summary

Supplemental Publications

78

Study type

Modify


X

ART Clinic Success Rates Report

Supplemental Publications

79

Transfer attempted

Modify

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

80

Reason transfer not attempted

Add


X

ART National Summary Report

Supplemental Publications

81

Transfer Date

Unchanged


X

ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

82

Endometrial Thickness

Add


X

Supplemental Publications

83

Number of Fresh Embryos Transferred to Uterus

Unchanged

X

X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

84

Elective single embryo transfer (fresh transfers)

Unchanged

X

X

ART Clinic Success Rates Report

ART National Summary Report

ART Surveillance Summary

Supplemental Publications

85

Quality of embryo (fresh transfers)

Add


X

ART National Summary Report

Supplemental Publications

86

Number of Fresh Embryos Cryopreserved

Unchanged


X

ART National Summary Report

Supplemental Publications

87

Number of Thawed Embryos Transferred to Uterus

Unchanged

X

X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

88

Elective single embryo transfer (frozen transfers)

Modify

X

X

ART Clinic Success Rates Report

ART National Summary Report

ART Surveillance Summary

Supplemental Publications

89

Quality of embryo (frozen transfers)

Add


X

ART National Summary Report

Supplemental Publications

90

Date of oocyte retrieval (thawed embryos)

Add

X


ART Clinic Success Rates Report

ART National Summary Report

Supplemental Publications

91

Number of Thawed Embryos Cryopreserved (re-frozen)

Unchanged


X

ART National Summary Report

Supplemental Publications

92

Number of Oocytes or embryos Transferred to Fallopian Tubes

Modify

X

X

ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

93

Outcome of Treatment (Not Pregnant, Biochemical Pregnancy, Ectopic Pregnancy, Clinical Intrauterine Gestation, Heterotopic Pregnancy, Unknown)

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

Supplemental Publications

94

Maximum Number of Fetal Hearts Observed on Ultrasound

Modify

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

95

Ultrasound Date

Modify


X

Supplemental Publications

96

Monochorionicity

Add


X

Supplemental Publications

97

Outcome of Pregnancy (Live birth, Stillbirth, Spontaneous Abortion, Induced Abortion, Maternal Death Prior to Birth, Unknown)

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

98

Date of Pregnancy Outcome

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

99

Method of delivery

Add


X

Supplemental Publications

100

Source of information on pregnancy outcome

Unchanged


X

Supplemental Publications

101

Number of Infants Born

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

Data Validation

ART Surveillance Summary

Supplemental Publications

102

Birth outcome for Each Infant

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

ART Surveillance Summary

Supplemental Publications

103

Gender for each liveborn or stillborn infant

Unchanged


X

Supplemental Publications

104

Birth weight for Each Live-born and Stillborn Infant

Unchanged

X


ART Clinic Success Rates Report

ART National Summary Report

ART Surveillance Summary

Supplemental Publications

105

Birth Defects Diagnosed for Each Live-born and Stillborn Infant (Genetic Defect/Chromosomal Abnormality, Cleft Lip or Palate, Neural Tube Defect, Cardiac Defect, Limb Defect, Other Defect)

Modify


X

Supplemental Publications

106

Lab Upper Normal Limit for that FSH level

Drop




107

Lab upper normal FSH unknown

Drop




108

FSH Unknown

Drop




109

Patient Maximum Estradiol Level

Drop




110

Lab Upper Normal Limit for that Estradiol Level

Drop




111

Number of Fresh Embryos Transferred to Fallopian Tubes

Drop




112

Number of Thawed Embryos Transferred to Fallopian Tubes

Drop




113

Surgical Sterilization—Patient or Partner

Drop




114

Was an Ultrasound Performed?

Drop




115

Donor medicated to stimulate follicular development

Drop




116

Donor medications containing clomiphene

Drop




117

Donor clomiphene dosage

Drop




118

Donor medications containing FSH

Drop




119

Donor GnRH protocol

Drop




120

Patient smoked 100 cigarettes during life

Drop




121

Average daily cigarettes smoked

Drop




See Attachment C6 for Detailed Item Descriptions

See Attachment C6 for detailed justification of changes, including citations from scientific literature

See Attachment C8-b for Success Rate Calculations and methodology

7


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