C1b_v3 National ART Surveillance System NASS 2.) (Proposed for

Assisted Reproductive Technology (ART) Program Reporting System

Att. C1b_v3 (Proposed) Future NASS screens for 2017

National ART Surveillance System

OMB: 0920-0556

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D R A F T











National ART Surveillance System

NASS 2.0

(Proposed for 2016)



DRAFT









INITIAL REPORTING: PATIENT PROFILE (prosPEctive)

Quex ID

LEAD QUESTION

1

Date of cycle reporting (mm/dd/yyyy): |__|__| - |__|__| - |__|__|__|__|

2

NASS Patient ID: |__|__|__|__| - |__|__|__|__| - |__|__|

3

Patient Optional Identifiers

Optional Identifier 1 |__|__|__|__|__|__|__|

maximum 7 digits or characters



Optional Identifier 2 |__|__|__|__|__|__|__|

maximum 7 digits or characters

4

Patient Date of Birth (mm/dd/yyyy): |__|__| - |__|__| - |__|__|__|__|

5

Sex of patient: Male Female

6

Cycle Start Date|__|__| - |__|__| - |__|__|__|__|


RESIDENCY

7

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

Yes

No

Refused

7A

Shape2 Shape1 U.S. state of primary residence:

City of primary residence

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

OR

Shape3 Country of primary residence:


INTENT

8

Intended type of ART? Select all that apply:

IVF: Transcervical

GIFT: Gametes to tubes

ZIFT: Zygotes to tubes or TET: tubal embryo transfer

Oocyte or embryo banking

9

[SKIP IF NOT A BANKING ONLY CYCLE]

If cycle is for banking only, specify banking type (select all that apply):

Embryo banking Autologous oocyte banking Donor oocyte banking

9A

Indicate anticipated duration of oocyte banking SKIP IF EMBRYO BANKING ONLY

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

9B

Indicate anticipated duration of embryo banking SKIP IF OOCYTE BANKING ONLY

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


10

Intended embryo source (select all that apply): [IF ONLY DONOR EMBRYOS SELECTED, SKIP TO #12]

Patient embryos

Donor embryos

Fresh embryos Frozen embryos


10A

If intent is to use FRESH EMBRYOS, specify intended oocyte source. Select all that apply:

Fresh patient oocytes Frozen patient oocytes

Fresh donor oocytes Frozen donor oocytes


If intent is to use FROZEN EMBRYOS, specify intended oocyte source. Select all that apply:

Fresh patient oocytes Frozen patient oocytes

Fresh donor oocytes Frozen donor oocytes Unknown (select only if oocyte source is unknown)

10B

If intend is to use donor embryos (select all that apply):

Fresh embryos Frozen embryos

11

Specify intended sperm source. Select all that apply. [SKIP IF DONOR EMBRYO IS INTENDED SOURCE]

Partner

Donor

Patient, if male

Unknown (select only if all sperm sources unknown for frozen)

12

Pregnancy carrier

Patient

Gestational carrier

None (oocyte or embryo banking cycle only)

CYCLE INFORMATION (NOT prosPEctive FROM HERE FORWARD)

Quex ID

LEAD QUESTION

13

Type of ART performed? Select all that apply:

IVF: Transcervical

GIFT: Gametes to tubes

ZIFT: Zygotes to tubes or TET: tubal embryo transfer

Oocyte or embryo banking

14

Embryo source (select all that apply): [IF ONLY DONOR EMBRYOS SELECTED, SKIP TO #15]

Patient embryos

Donor embryos

Fresh embryos Frozen embryos


14A

If FRESH EMBRYOS were used, specify intended oocyte source. Select all that apply:

Fresh patient oocytes Frozen patient oocytes

Fresh donor oocytes Frozen donor oocytes


If FROZEN EMBRYOS were used, specify intended oocyte source. Select all that apply:

Fresh patient oocytes Frozen patient oocytes

Fresh donor oocytes Frozen donor oocytes Unknown (select only if oocyte source is unknown)

PATIENT MEDICAL EVALUATION


REASON FOR ART

Quex ID

LEAD QUESTION

15

Reason for ART (Select all that apply):

Male infertility (select all that apply)

[SKIP IF MALE INFERTILITY NOT SELECTED]

  • Medical condition

  • Genetic or chromosomal abnormality Specify___________

  • Abnormal sperm parameters (select all that apply)

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 historic hydrosalpinx)

Ovulatory disorders

[SKIP IF OVULATORY DISORDER NOT SELECTED]

PCO Other ovulatory disorders

Diminished ovarian reserve

Uterine factor

Preimplantation Genetic Diagnosis 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 AND PHYSICAL

16

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


Height:

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

or

Height unknown

17

Weight at the start of this cycle

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

or

Weight unknown

18

History of cigarette smoking:

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


Yes

No

Unknown

19

Any prior pregnancies?

Yes

No

19A

[SKIP IF NO PRIOR PREGNANCIES]

If prior pregnancies reported and couple is not surgically sterile, enter months 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 attempting pregnancy

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

19B

SKIP IF NO PRIOR PREGNANCIES

If prior pregnancies reported, how many |__|__|

19C

Number of prior full term births |__|__|

19D

Number of prior preterm births |__|__|

19E

Number of prior stillbirths |__|__|

19F

Number of prior spontaneous abortions |__|__|

19G

Number of ectopic pregnancies |__|__|

20

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

21

Number of prior frozen ART cycles: |__|__|

21A

SKIP IF NO PRIOR ART CYCLES

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

22

Patient maximum FSH level (MIU/mls): |__|__|__| . |__|__|

Or FSH unknown:

23

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

Or AMH unknown:


Date of most recent AMH level |__|__| - |__|__| - |__|__|__|__|


SOURCE AND CARRIER PROFILES


OOCYTE SOURCE PROFILE

Quex ID

LEAD QUESTION

24A

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

Youngest oocyte source


Patient [SKIP TO Q25]

Donor [CONTINUE TO Q24)

24B

OOCYTE SOURCE Date of Birth (mm/dd/yyyy): [FIELD PRE-FILLED IF OOCYTE SOURCE=PATIENT]

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


OR age at earliest time oocytes were retrieved ____

25

OOCYTE SOURCE Ethnicity:

Select one:

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown



26

OOCYTE SOURCE Race (based on oocyte source self-report)

Select all that apply:

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

26A


Select reason race not reported:

Refused

Unknown



PREGNANCY CARRIER PROFILE

27

Pregnancy carrier

Patient

Gestational carrier

None (oocyte or embryo banking cycle only)

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 ____


29

Pregnancy carrier Ethnicity:

Select one:

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown


30

Pregnancy carrier Race (based on gestational carrier self report)

Select all that apply:

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

30A

Yes


Select reason race not reported:

Refused

Unknown

Quex ID

LEAD QUESTION


SPERM SOURCE PROFILE

31

Specify sperm source. Select all that apply.

Partner

Donor

Patient, if male

Unknown (select only if all sperm sources unknown for frozen)

32


SPERM source Date of Birth (mm/dd/yyyy):|__|__| - |__|__| - |__|__|__|__| [FIELD PRE-FILLED IF SPERM SOURCE=MALE PATIENT]

Or

Unknown

33

SPERM source Ethnicity:

Select one:

NOT Hispanic or Latino

Hispanic or Latino

Refused

Unknown

34

SPERM source Race (based on patient self report)

Select all that apply:

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaska Native

34A


Select reason race not reported:

Refused

Unknown

STIMULATION AND RETRIEVAL

Quex ID

LEAD QUESTION


OVARIAN STIMULATION AND MEDICATIONS

35

Was there stimulation for follicular development? [IF NO STIMULATION OR FROZEN CYCLE, SKIP #36-39]

Yes ⃝ No


Was this a minimal stimulation cycle?


Yes ⃝ No


36

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

Yes ⃝ No

36A

[SKIP IF NO ORAL MEDS]

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

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

Other (specify)_________ dosage |__|__|__|__|__| . |__|__|

37

Medication(s) containing FSH?

Yes ⃝ No

37A

[SKIP IF NO FSH MEDS]

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

37B

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

38

Medication(s) with LH/HCG activity?

Yes ⃝ No

Quex ID

LEAD QUESTION

39

GnRH Protocol

Select the one primary protocol:

No GnRH protocol

GnRH Agonist Suppression

GnRH Agonist Flare

GnRH Antagonist Suppression


CANCELLATION-I (open only for fresh cycles)

40

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


Was this ART cycle canceled prior to retrieval?

Yes ⃝ No

40A

[SKIP IF CYCLE NOT CANCELLED]

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

40B

Select one primary reason cycle was canceled:

Low ovarian response

High ovarian response

Inadequate endometrial response

Concurrent illness

Withdrawal only for personal reasons

OTHER – specify ____________________________


[IF CYCLE CANCELLED, STOP HERE]


FRESH OOCYTE RETRIEVAL

41


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

42

Total number of patient oocytes retrieved: |__|__|

43

Total number of donor oocytes retrieved: |__|__|

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

44A

[SKIP IF NO OOCYTES FROZEN]

Number of FRESH oocytes frozen for future use: |__|__|


COMPLICATIONS OF OVARIAN STIMULATION OR OOCYTE RETRIEVAL


45

Were there any complications of ovarian stimulation or oocyte retrieval?

Yes ⃝ No

45A

SKIP IF NO COMPLICATIONS

Select all complications that apply:

Infection

Hemorrhage requiring transfusion

Ovarian hyperstimulation requiring intervention or hospitalization

Medication side effect

Anesthetic complication

Thrombosis

Death of patient

Other – specify ___________________

45B

SKIP IF NO COMPLICATIONS

Did the complication(s) require hospitalization?

Yes ⃝ No



[IF OOCYTE BANKING CYCLE ONLY, STOP HERE]




SPERM RETRIEVAL

46

Sperm status:

Fresh

Thawed

Mix of fresh and thawed

47

Sperm source utilized:

Ejaculated

Epididymal

Testis

Electroejaculation

Retrograde urine

Donor

Unknown

LABORATORY INFORMATION

Quex ID

LEAD QUESTION


MANIPULATION

48

Intracytoplasmic sperm injection (ICSI) performed on oocytes?

All oocytes

Some oocytes

No oocytes

Unknown

48A

SKIP IF NO ICSI

Indication for ICSI (select all that apply)

Prior failed fertilization

Poor fertilization

PGD

Abnormal semen parameters on day of fertilization

Low oocyte yield

Laboratory routine

Frozen cycle

Rescue ICSI

Other – specify ______________

49

In vitro maturation (IVM) performed on oocytes?

All oocytes

Some oocytes

No oocytes

Unknown

50

Pre-implantation genetic diagnosis or screening performed on embryos?

Yes

No

Unknown

50A

SKIP IF PGD/PGS NOT PERFORMED OR UNKNOWN

Total number of 2PN: |__|__|

50B

Reason(s) for pre-implantation genetic diagnosis or screening (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

50C

Technique(s) used for pre-implantation genetic diagnosis or screening (Select all that apply):

Polar Body Biopsy

Blastomere Biopsy

Blastocyst Biopsy

Unknown

51

Assisted hatching performed on embryos?

All embryos

Some embryos

No embryos

Unknown

52

Was this a research cycle?

Yes Enter SART approval code_____________

No

52A

SKIP IF NOT RESEARCH CYCLE

Study type:

Device study

Protocol study

Pharmaceutical study

Laboratory technique

Other research



If ‘Other’, please specify ______________________________


[IF EMBRYO BANKING CYCLE ONLY, SKIP TO #59, THEN STOP]

TRANSFER

Quex ID

LEAD QUESTION


CANCELLATION-II

53

Was a transfer attempted?

Yes ⃝ No

53A


Select one 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

54

Date of embryo transfer (mm/dd/yyyy): |__|__| - |__|__| - |__|__|__|__|

55

Endometrial thickness at trigger: |__|__|mm


FRESH EMBRYO TRANSFER DETAILS

56

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

Number of FRESH embryos transferred to uterus: |__|__|

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

58A-X

Quality of embryo #1–X

Good

Fair

Poor

Unknown



Date of oocyte retrieval for embryo #1-X |__|__| - |__|__| - |__|__|__|__|

59

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


THAWED EMBRYO TRANSFER DETAILS


60

Number of FROZEN or THAWED embryos available on day of transfer: |__|__|

61

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

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

62A-X

Quality of embryo #1–X

Good

Fair

Poor

Unknown



Date of oocyte retrieval for embryo #1-X |__|__| - |__|__| - |__|__|__|__|

63

Number of THAWED embryos cryopreserved (re-frozen): |__|__|


GIFT/ZIFT/TET TRANSFER DETAILS

64

[SKIP IF IVF CYCLE]

Number of oocytes or embryos transferred to the FALLOPIAN TUBE: |__|__|

TREATMENT OUTCOME (only opens if transfer >0)

Quex ID

LEAD QUESTION


OUTCOME OF TRANSFER

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]

66


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

No ultrasound performed before 7 weeks gestation

66A

[SKIP IF NO U/S]

Date ultrasound with max. number of fetal hearts observed before 7 weeks (mm/dd/yyyy):

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

66B

[SKIP IF NO U/S]

If 2 or more fetal hearts, any monochorionic twins or multiples? ⃝Yes ⃝ No ⃝Unknown

PREGNANCY OUTCOME (only opens if pregnancy = yes)

Quex ID

LEAD QUESTION


OUTCOME OF PREGNANCY

67

Outcome of pregnancy:

Live birth

Spontaneous abortion

Stillbirth

Induced abortion

Maternal death prior to birth

Outcome unknown

68

Date of pregnancy outcome (mm/dd/yyyy):

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

NOTE: If multiple births cover more than one date, enter date of first born.

68A

Method of delivery

Vaginal

Cesarean section

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


BIRTH INFORMATION


70

Number of infants born: |__|__|

71A-X

Birth Status infant #1-X

Live birth
Stillbirth
Unknown


72A-X

Gender infant #1-X

Male

Female


Unknown

73A-X

Weight in pounds and ounces, or grams infant #1-X

|__|__| lbs and |__|__| oz. OR |__|__|__|__| g

OR

Weight unknown

74A-X

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

None

Cleft lip/palate

Genetic defect/chromosomal abnormality

Neural tube defect

Cardiac defect

Limb defect

Other (specify) OR Unknown



14


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