Att C1b_v4 NASS screens_04_17_2017_changes highlighted

Att C1b_v4 NASS screens_04_17_2017_changes highlighted.docx

Assisted Reproductive Technology (ART) Program Reporting System

Att C1b_v4 NASS screens_04_17_2017_changes highlighted

OMB: 0920-0556

Document [docx]
Download: docx | pdf

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National ART Surveillance System

NASS 2.0



DRAFT









INITIAL REPORTING



PATIENT PROFILE

Date

1

Date of cycle reporting |__|__| - |__|__| - |__|__|__|__|

Pre-fill

2

NASS patient ID |__|__|__|__| - |__|__|__|__| - |__|__|

Text

3

Patient optional identifiers

Optional identifier 1 |__|__|__|__|__|__|__|

Maximum 7 numbers or letters




Optional identifier 2 |__|__|__|__|__|__|__|

Maximum 7 numbers or letters

Date

4

Patient date of birth (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|

Radio

5


Sex of patient Female ⃝ Male


Drop-down

5A

Patient ethnicity

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown


Checkbox (MR)

5B

Patient race (select all that apply)

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

Or

Drop-down

5C

Reason race not reported

Refused

Unknown

Date

6

Cycle start date|__|__| - |__|__| - |__|__|__|__|



RESIDENCY

Radio

7

At the start of cycle, is patient residency primarily in U.S.?

Yes

No

Refused

Drop-down

7A

U.S. city of primary residence

Drop-down

U.S. state of primary residence

Text

U.S. zip code of primary residence |__|__|__|__|__|

Drop-down

Or

Country of primary residence



INTENT

Checkbox

(MR + SR)

8

Intended type of ART (select all that apply)

IVF: Transcervical

GIFT: Gametes to tubes

ZIFT: Zygotes to tubes or TET: tubal embryo transfer

Or

Oocyte or embryo banking

Checkbox (MR)

9

[SKIP IF NOT A BANKING ONLY CYCLE]

Banking type (select all that apply)

Embryo banking Autologous oocyte banking Donor oocyte banking

Checkbox (MR)

9A

Intended duration of oocyte banking (select all that apply)

Short term (<12 months)

Long term (≥12 months) banking for fertility preservation prior to gonadotoxic medical treatments

Long term (≥12 months) banking for other reasons

Checkbox (MR)

9B

Intended duration of embryo banking (select all that apply)

Short term (<12 months)

  • Delay of transfer to obtain genetic information

  • Delay of transfer for other reasons

Long term (≥12 months) banking for fertility preservation prior to gonadotoxic medical treatments

Long term (≥12 months) banking for other reasons


[IF BANKING ONLY, SKIP TO #11 AFTER #9 IS COMPLETED]

Checkbox (MR)

10

Intended embryo source (select all that apply)

Patient embryos

Donor embryos (donated from another patient’s IVF cycle)

FRESH embryos FROZEN embryos

Checkbox (MR)

10A

Intended oocyte source and state for FRESH embryos (select all that apply)

PATIENT oocytes PATIENT frozen oocytes

DONOR fresh oocytes DONOR frozen oocytes


Intended oocyte source and state for FROZEN embryos (select all that apply)

PATIENT fresh oocytes PATIENT frozen oocytes

DONOR fresh oocytes DONOR frozen oocytes DONOR Unknown (select only if oocyte source is unknown)

Checkbox (MR + SR)

11

Intended sperm source (select all that apply) [SKIP IF DONOR EMBRYO IS INTENDED SOURCE]

Partner

Donor

Patient, if male

Or

Unknown (select only if all sperm sources unknown)

Drop-down

12

Intended pregnancy carrier

Patient

Gestational carrier

None (oocyte or embryo banking cycle only)








ART PERFORMED



ART PERFORMED

Checkbox (MR + SR)

13

Type of ART performed (select all that apply)

IVF: Transcervical

GIFT: Gametes to tubes

ZIFT: Zygotes to tubes or TET: tubal embryo transfer

Or

Oocyte or embryo banking [SKIP TO #15 IF BANKING SELECTED]

Checkbox (MR)

14

Embryo source (select all that apply)

Patient embryos

Donor embryos (donated from another patient’s IVF cycle)

FRESH embryos FROZEN embryos

Checkbox (MR)

14A

Oocyte source and state for FRESH embryos (select all that apply)

PATIENT fresh oocytes PATIENT frozen oocytes

DONOR fresh oocytes DONOR frozen oocytes


Oocyte source and state for FROZEN embryos (select all that apply)

PATIENT fresh oocytes PATIENT frozen oocytes

DONOR fresh oocytes DONOR frozen oocytes DONOR Unknown (select only if oocyte source is unknown)



REASON FOR ART



REASON FOR ART

Checkbox (MR)

15

Reason for ART (select all that apply)

Male infertility



[SKIP IF MALE INFERTILITY NOT SELECTED]

  • Medical condition

  • Genetic or chromosomal abnormality (specify) ___________

  • Abnormal sperm parameters

Azoospermia, obstructive

Azoospermia, non-obstructive

Oligospermia, severe (<5 million/mL)

Oligospermia, moderate (5-15 million/mL)

Low motility (<40%)

Low morphology (4%)

  • Other male factor (not included above) (specify) ___________



History of endometriosis



Tubal ligation for contraception



Current or prior hydrosalpinx



[SKIP IF HYDROSALPINX NOT SELECTED]

Communicating Occluded Unknown



Other tubal disease (not current or prior hydrosalpinx)

Ovulatory disorders



[SKIP IF OVULATORY DISORDER NOT SELECTED]

Polycystic ovaries (PCO) Other ovulatory disorders



Diminished ovarian reserve



Uterine factor



Preimplantation genetic diagnosis (including aneuploidy screening) as primary reason for ART



Oocyte or embryo banking as reason for ART



Indication for use of gestational carrier



[SKIP IF GESTATIONAL CARRIER NOT INDICATED]

  • Absence of uterus

  • Significant uterine anomaly

  • Medical contraindication to pregnancy

  • Recurrent pregnancy loss

  • Unknown



Recurrent pregnancy loss



Other reasons related to infertility (specify) ________ _________ _______



Other reasons not related to infertility (specify) ________ _________ _______



Unexplained infertility



FEMALE PATIENT HISTORY & PHYSICAL



FEMALE PATIENT HISTORY & PHYSICAL

Text, checkbox (SR)

16

[IF SEX OF PATIENT = MALE (FROM QUESTION #5) THEN SKIP #16-23]

Height

|__| Feet and/or |__|__| Inches or |__|__|__|__| Centimeters

Or

Height unknown

Text, checkbox (SR)

17

Weight at the start of this cycle

|__|__|__|__| Pounds or |__|__|__|__| Kilograms

Or

Weight unknown

Radio

18

Did the patient smoke during the 3 months before the cycle started?

Yes

No

Unknown

Radio

19

Any prior pregnancies?

Yes

No

Text

19A

[SKIP IF NO PRIOR PREGNANCIES]

If prior pregnancies reported and couple is not surgically sterile, enter months and/or years attempting pregnancy since last clinical pregnancy |__|__|__| months and/or |__|__| years


[SKIP IF ANY PRIOR PREGNANCIES]

If no prior pregnancies reported and couple is not surgically sterile, enter months and/or years attempting pregnancy

|__|__|__| months and/or |__|__| years

Text

19B

[SKIP IF NO PRIOR PREGNANCIES]

Number of prior pregnancies |__|__|

19C

Number of prior full term births (live and stillbirths) |__|__|

19D

Number of prior preterm births (live and stillbirths) |__|__|

19E

Number of prior stillbirths |__|__|

19F

Number of prior spontaneous abortions |__|__|

19G

Number of prior ectopic pregnancies |__|__|

20

Number of prior stimulations for fresh ART cycles |__|__|

21

Number of prior ART cycles started with the intent to transfer oocytes or embryos |__|__|

Radio

21A

SKIP IF NO PRIOR ART CYCLES

Did any prior ART cycles result in a live birth? Yes No

Text, checkbox (SR)

22

Maximum FSH level (MIU/mls) |__|__|__| . |__|__|

Or

FSH level unknown

Text, checkbox (SR), date

23

Most recent AMH level (ng/mL) |__|__|__| . |__|__|

Or

AMH level unknown


Date of most recent AMH level (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|



SOURCES & CARRIERS



OOCYTE SOURCE PROFILE

Radio

24A

[IF OOCYTE SOURCE = PATIENT AND DONOR, ANSWER THIS QUESTION]

Youngest oocyte source

Patient [SKIP TO Q25]

Donor [CONTINUE TO Q24B)

Date, drop-down,

checkbox (SR)

24B

Oocyte source date of birth (mm/dd/yyyy) [FIELD PRE-FILLED IF OOCYTE SOURCE=PATIENT]

|__|__| - |__|__| - |__|__|__|__|

Or

Age at earliest time oocytes were retrieved ____


Drop-down

25

Oocyte source ethnicity

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown


Checkbox (MR)

26

Oocyte source race (select all that apply)

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

Or

Drop-down

26A

Reason race not reported

Refused

Unknown

Text, checkbox (SR)

O1

Oocyte source height

|__| Feet and/or |__|__| Inches or |__|__|__|__| Centimeters

Or

Height unknown

Text, checkbox (SR)

O2

Oocyte source weight

|__|__|__|__| Pounds or |__|__|__|__| Kilograms

Or

Weight unknown

Radio

O3

Did the oocyte source smoke during the 3 months before the cycle started?

Yes

No

Unknown

Radio

O3

Any prior pregnancies?

Yes

No

Text

O4

[SKIP IF NO PRIOR PREGNANCIES]

If prior pregnancies reported and couple is not surgically sterile, enter months and/or years attempting pregnancy since last clinical pregnancy |__|__|__| months and/or |__|__| years


[SKIP IF ANY PRIOR PREGNANCIES]

If no prior pregnancies reported and couple is not surgically sterile, enter months and/or years attempting pregnancy

|__|__|__| months and/or |__|__| years

Text


[SKIP IF NO PRIOR PREGNANCIES]

Number of prior pregnancies |__|__|

O5A

Number of prior full term births (live and stillbirths) |__|__|

O5B

Number of prior preterm births (live and stillbirths) |__|__|

O5C

Number of prior stillbirths |__|__|

O5D

Number of prior spontaneous abortions |__|__|

O5E

Number of prior ectopic pregnancies |__|__|

O5F

Number of prior stimulations for ART cycles |__|__|

O5G

Number of prior ART cycles with the intent to transfer oocytes or embryos |__|__|

Radio

O6H

SKIP IF NO PRIOR ART CYCLES started with intent to transfer

Did any prior ART cycles started with the intent to transfer oocytes or embryos result in a live birth? Yes No

Text, checkbox (SR)

O6

Maximum FSH level (MIU/mls) |__|__|__| . |__|__|

Or

FSH level unknown

Text, checkbox (SR), date

O7

Most recent AMH level (ng/mL) |__|__|__| . |__|__|

Or

AMH level unknown


Date of most recent AMH level (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|



PREGNANCY CARRIER PROFILE

Drop-down

27

Pregnancy carrier

Patient

Gestational carrier

None (oocyte or embryo banking cycle only)

Date, drop-down,

Checkbox (SR)

28

[IF CARRIER=NONE THEN SKIP 28-31] or

[IF CARRIER=PATIENT AND OOCYTE SOURCE=PATIENT THEN SKIP 28-31]


Pregnancy carrier date of birth (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|

Or

Age at time of transfer ____

Drop-down

29

Pregnancy carrier ethnicity

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown

Checkbox (MR)

30

Pregnancy carrier race (select all that apply)

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

Or

Drop-down

30A

Reason race not reported

Refused

Unknown



SPERM SOURCE PROFILE

Checkbox

(MR + SR)

31

Specify sperm source (select all that apply)

Partner

Donor

Patient, if male

Or

Unknown (select only if all sperm sources unknown)

Date, checkbox (SR)

32

Sperm source date of birth (mm/dd/yyyy)|__|__| - |__|__| - |__|__|__|__| [FIELD PRE-FILLED IF SPERM SOURCE=MALE PATIENT]

Or

Sperm source DOB unknown

Drop-down

33

Sperm source ethnicity

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown

Checkbox (MR)

34

Sperm source race (select all that apply)

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

Or

Drop-down

34A

Reason race not reported

Refused

Unknown



STIMULATION & MEDICATIONS



STIMULATION & MEDICATIONS

Radio

35

Was there stimulation for follicular development?

Yes ⃝ No


[IF NO STIMULATION OR FROZEN CYCLE, SKIP #36-39]



Was this a minimal stimulation cycle?

Yes ⃝ No

Radio

36

Oral medication such as aromatase inhibitor or selective estrogen receptor modulator used

Yes ⃝ No

Text

36A

[SKIP IF NO ORAL MEDS]

Clomiphene dosage (Total mgs): |__|__|__|__|__| . |__|__|

Letrozole dosage (Total mgs) |__|__|__|__|__| . |__|__|

Other oral medication (specify)_________ Other oral medical dosage (specify) |__|__|__|__|__| . |__|__|

Radio

37

Medication containing FSH used

Yes ⃝ No

Text

37A

[SKIP IF NO FSH MEDS]

Short-acting FSH (Total IUs) |__|__|__|__|__| . |__|__|

Text

37B

Long-acting FSH (Total mgs) |__|__|__|__|__| . |__|__|

Radio

38

Medication with LH/HCG activity used

Yes ⃝ No

Radio

39

Primary GnRH protocol used

No GnRH protocol

GnRH Agonist Suppression

GnRH Agonist Flare

GnRH Antagonist Suppression



CANCELLATION

Radio

40

[IF OOCYTE/EMBRYO SOURCE = FROZEN THEN SKIP 40-45]


Cycle canceled prior to retrieval?

Yes ⃝ No

Date

40A

[SKIP IF CYCLE NOT CANCELLED]

Date cycle canceled (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|

Radio, text

40B

Primary reason cycle was canceled

Low ovarian response

High ovarian response

Inadequate endometrial response

Concurrent illness

Withdrawal only for personal reasons

Other (specify) ____________________________



RETRIEVAL



FRESH OOCYTE RETRIEVAL

Date

41

Date retrieval performed (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|

Text

42

Number of patient oocytes retrieved |__|__|

Text

43

Number of donor oocytes retrieved |__|__|

Checkbox (MR)

44

Use of retrieved oocytes (select all that apply)

Used for this cycle

Oocytes frozen for future use

Oocytes shared with other patients

Embryos frozen for future use



Were there any oocyte retrieval performed from other clinics?

Yes ⃝ No

Text

44A

[SKIP IF NO OOCYTES FROZEN]

Number of fresh oocytes frozen for future use |__|__|



COMPLICATIONS OF OVARIAN STIMULATION OR OOCYTE RETRIEVAL

Radio

45

Were there any complications of ovarian stimulation or oocyte retrieval?

Yes ⃝ No

Checkbox (MR),

text

45A

[SKIP IF NO COMPLICATION]

Complications (select all that apply)

Infection

Hemorrhage requiring transfusion

Ovarian hyperstimulation requiring intervention or hospitalization

Medication side effect

Anesthetic complication

Thrombosis

Death of patient

Other (specify) ___________________

Radio

45B

[SKIP IF NO COMPLICATION]

Did the complication(s) require hospitalization?

Yes ⃝ No




SPERM RETRIEVAL

Radio

46

Sperm status

Fresh

Thawed

Mix of fresh and thawed

Radio

47

Sperm source utilized

Ejaculated

Epididymal

Testis

Electroejaculation

Retrograde urine

Donor

Unknown



MANIPULATION



MANIPULATION

Radio

48

Intracytoplasmic sperm injection (ICSI) performed on oocytes?

All oocytes

Some oocytes

No oocytes

Unknown

Checkbox (MR), text

48A

SKIP IF NO ICSI

Indication for ICSI (select all that apply)

Prior failed fertilization

Poor fertilization

PGD or PGS

Abnormal semen parameters on day of fertilization

Low oocyte yield

Laboratory routine

Frozen oocyte

Rescue ICSI

Other (specify) ______________

Radio

49

In vitro maturation (IVM) performed on oocytes?

All oocytes

Some oocytes

No oocytes

Unknown

Radio

50

Pre-implantation genetic diagnosis (PGD) or screening (PGS) performed on embryos?

Yes

No

Unknown

Text

50A

SKIP IF PGD/PGS NOT PERFORMED OR UNKNOWN

Total number of 2PN |__|__|

Checkbox (MR)

50B

Reason for PGD or PGS (select all that apply)

Either genetic parent is a known carrier of a gene mutation or a chromosomal abnormality

Aneuploidy screening of the embryos

Elective gender determination

Other screening of the embryos

Checkbox (MR + SR)

50C

Technique used for PGD or PGS (select all that apply)

Polar Body Biopsy

Blastomere Biopsy

Blastocyst Biopsy

Or

Unknown

Radio

51

Assisted hatching performed on embryos?

All embryos

Some embryos

No embryos

Unknown

Radio

52

Was this a research cycle?

Yes

No

Checkbox (MR), text

52A

[SKIP IF NOT RESEARCH CYCLE]

Study type (select all that apply)

Device study

Protocol study

Pharmaceutical study

Laboratory technique

Other research (specify) ______________________

Text

52B


Approval code_____________



TRANSFER



TRANSFER ATTEMPT

Radio

53

Was a transfer attempted?

Yes ⃝ No

Radio, text

53A

[SKIP IF TRANSFER ATTEMPTED]

Primary reason no transfer was attempted

Low ovarian response

High ovarian response

Failure to survive oocyte thaw

Inadequate endometrial response

Concurrent illness

Withdrawal only for personal reasons

Unable to obtain sperm specimen

Insufficient embryos

Other (specify) ____________________________



[IF TRANSFER NOT ATTEMPTED, STOP HERE]



GENERAL TRANSFER DETAILS

Date

54

Date transfer performed (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|

Text

55

Endometrial thickness at trigger |__|__|mm



FRESH EMBRYO TRANSFER DETAILS

Text

55N

Number of fresh embryos available on day of transfer |__|__|

Text

56

[IF NO FRESH EMBRYOS TRANSFERRED, SKIP #57-58]

Number of fresh embryos transferred to uterus |__|__|

Radio

57

[SKIP #57 FOR MIXED CYCLE]

If only one fresh embryo was transferred to the uterus, was this an elective single embryo transfer?

Yes ⃝ No

Drop-down

58A-X

Quality of embryo #1–X

Good

Fair

Poor

Unknown

Drop-down, date, checkbox (SR)

58B


Date of oocyte retrieval for embryo #1-X (mm/dd/yyyy) [DROPDOWN]

Or

|__|__| - |__|__| - |__|__|__|__|


58C

Was the oocyte used to create the fresh embryo #1-X retrieved in a different clinic?

Yes ⃝ No

If Yes, state [dropdown], city [dropdown], name of clinic [dropdown]

or _______________________________________[text], if not found in the dropdown menu

Text

59

Number of fresh embryos cryopreserved |__|__| [STOP HERE FOR EMBRYO BANKING ONLY CYCLE]



FROZEN EMBRYO TRANSFER DETAILS

Text

60

Number of frozen or thawed embryos available on day of transfer |__|__|

Text

61

Number of thawed embryos transferred to uterus |__|__| [IF NO THAWED EMBRYOS TRANSFERRED, SKIP #62]

Radio

62

[SKIP #63 FOR MIXED CYCLE]

If only one thawed embryo was transferred to the uterus, was this an elective single embryo transfer?

Yes ⃝ No

Drop-down

62A-X

Quality of embryo #1–X

Good

Fair

Poor

Unknown

Drop-down, date

62B


Date of oocyte retrieval for embryo #1-X (mm/dd/yyyy) [DROPDOWN]

Or

|__|__| - |__|__| - |__|__|__|__|


62C

Was the oocyte used to create the thawed embryo #1-X retrieved in a different clinic?

Yes ⃝ No

If Yes, state [dropdown], city [dropdown], name of clinic [dropdown]

or _______________________________________[text], if not found in the dropdown menu

Text

63

Number of thawed embryos cryopreserved (re-frozen) |__|__|



GIFT/ZIFT/TET TRANSFER DETAILS

Text

64

[SKIP IF IVF CYCLE]

Number of oocytes or embryos transferred to the fallopian tube |__|__|



OUTCOMES



OUTCOME OF TRANSFER

Radio

65

Outcome of treatment cycle

Not pregnant

Biochemical only

Clinical intrauterine gestation

Ectopic

Heterotopic

Unknown


[IF NOT PREGNANT, BIOCHEMICAL ONLY, ECTOPIC, OR HETEROTOPIC, STOP HERE]

Text, checkbox (SR)

66


Maximum number of fetal hearts on ultrasound performed before 7 weeks or prior to reduction |__|__|

No ultrasound performed before 7 weeks gestation or prior to reduction

Date

66A

[SKIP IF NO U/S]

Ultrasound date with maximum number of fetal hearts observed before 7 weeks or prior to reduction (mm/dd/yyyy)

|__|__| - |__|__| - |__|__|__|__|

Radio

66B

[SKIP IF NO U/S]

Any monochorionic twins or multiples? ⃝Yes ⃝ No ⃝Unknown



OUTCOME OF PREGNANCY

Radio

67

Outcome of pregnancy

Live birth

Spontaneous abortion

Stillbirth

Induced abortion

Maternal death prior to birth

Outcome unknown

Date

68

Date of pregnancy outcome (mm/dd/yyyy)

|__|__| - |__|__| - |__|__|__|__|

Checkbox (MR)

69

Source of information confirming pregnancy outcome (select all that apply)

Verbal confirmation from patient

Written confirmation from patient

Verbal confirmation from physician or hospital

Written confirmation from physician or hospital



[If spontaneous abortion, induced abortion, maternal death prior to birth, or outcome unknown, STOP here]

Text

70

Number of infants born |__|__|

Radio

69N

Method of delivery

Vaginal ⃝ Cesarean ⃝ Unknown



BIRTHS



BIRTH INFORMATION

Radio

71A-X

Infant #1-X: Birth status

Live born

Stillborn
Unknown


Radio

72A-X

Infant #1-X: Gender

Male

Female


Unknown

Drop-down, text, checkbox (SR)

73A-X

Infant #1-X: Weight

|__|__| Pounds And |__|__| Ounces Or |__|__|__|__| Grams

Or

Weight unknown

Checkbox (MR + SR)

74A-X

Infant #1-X: Birth defects (select all that apply)

Cleft lip/palate

Genetic defect/chromosomal abnormality

Neural tube defect

Cardiac defect

Limb defect

Other (specify)

Or

Birth defects unknown

Or

None



[END]



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