National ART Surveillance System (NASS) [screen captures

Assisted Reproductive Technology (ART) Program Reporting System

Att C1. NASS Data collection 2.24.21

OMB: 0920-0556

Document [pdf]
Download: pdf | pdf
NASS 2.0 Log-in Web Page

Expiration Date: xx-xx-xxxx
Expiration Date: 08-31-2021

NASS OMB Burden: Public reporting burden of this collection of information is estimated to average 43 minutes per response, including the time for reviewing instructions, searching existing data sources,
gathering, and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing
this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0556).

INITIAL REPORTING PAGE
PATIENT PROFILE SECTION
NASS patient ID |__|__|__|__| - |__|__|__|__| - |__|__|
Patient optional identifiers
Optional identifier 1 |__|__|__|__|__|__|__|
Optional identifier 2 |__|__|__|__|__|__|__|
Patient date of birth (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Sex of patient
⃝ Female
⃝ Male
Patient ethnicity
⃝ NOT Hispanic or Latino
⃝ Hispanic or Latino
⃝ Refused
⃝ Unknown
Patient race (select all that apply)
White
Black or African American
Asian
Native Hawaiian or other Pacific Islander
American Indian or Alaska Native
(OR)
Reason race not reported
⃝ Refused
⃝ Unknown
Cycle start date (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|

RESIDENCY SECTION
At the start of cycle, is patient residency primarily in U.S.?
⃝ Yes
⃝ No
⃝ Refused
U.S. state of primary residence |_______________________________________________________|
U.S. city of primary residence |________________________________________________________|
U.S. zip code of primary residence |____________________________________________________|
Country of primary residence |_________________________________________________________|
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

(continued next page)
INITIAL REPORTING PAGE (continued)
INTENT SECTION
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
[IF IVF/GIFT/ZIFT] Intended embryo source (select all that apply)
Patient embryos
Intended oocyte source and state for FRESH patient embryos (select all that apply)
PATIENT fresh oocytes
DONOR fresh oocytes
PATIENT frozen oocytes
DONOR frozen oocytes
Intended oocyte source and state for FROZEN patient embryos (select all that apply)
PATIENT fresh oocytes
DONOR fresh oocytes
PATIENT frozen oocytes
DONOR frozen oocytes
DONOR unknown (select only if oocyte source is unknown)
Donor embryos (donated from another patient’s IVF cycle)
FRESH donated embryos
FROZEN donated embryos
[IF BANKING] Banking type (select all that apply)
Embryo banking
Autologous oocyte banking
Donor oocyte banking
[IF EMBRYO BANKING] Intended source for embryo banking (select all that apply)
Embryo banking from autologous oocytes
Embryo banking from donor oocytes

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

[IF EMBRYO BANKING] 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
(continued next page)
INITIAL REPORTING PAGE (continued)

[IF AUTOLOGOUS OR DONOR OOCYTE BANKING] 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
Intended sperm source (select all that apply)
Partner
Donor
Patient, if male
(OR)
Unknown (select only if all sperm sources unknown)
Intended pregnancy carrier
⃝ Patient

⃝

⃝ Gestational carrier
None (oocyte or embryo banking cycle only)

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

ART PERFORMED PAGE
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

[IF IVF/GIFT/ZIFT] Embryo source (select all that apply)
Patient embryos
Oocyte source and state for FRESH patient embryos (select all that apply)
PATIENT fresh oocytes
DONOR fresh oocytes
PATIENT frozen oocytes
DONOR frozen oocytes
Oocyte source and state for FROZEN patient embryos (select all that
apply)
PATIENT fresh oocytes
DONOR fresh oocytes
PATIENT frozen oocytes
DONOR frozen oocytes
DONOR unknown (select only if oocyte source is unknown)
Donor embryos (donated from another patient’s IVF cycle)
FRESH donated embryos
FROZEN donated embryos

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

REASON FOR ART PAGE
Reason for ART (select all that apply)
Male infertility
Medical condition
Genetic or chromosomal abnormality (specify) |________________________________________________________|
Abnormal sperm parameters
Azoospermia, obstructive
Azoospermia, non-obstructive
Oligozoospermia, severe (<5 million/mL)
Oligozoospermia, moderate (5-15 million/mL)
Low motility (<40%)
Low morphology (4%)
Other male factor (specify) |________________________________________________________|
History of endometriosis
Tubal ligation for contraception
Current or prior hydrosalpinx
Communicating
Occluded
Unknown (current or prior hydrosalpinx)
Other tubal disease (not current or prior hydrosalpinx)
Ovulatory disorders
Polycystic ovaries (PCO)
Other ovulatory disorders
Diminished ovarian reserve
Uterine factor
Preimplantation genetic testing (including aneuploidy screening) as reason for ART
Oocyte or embryo banking as reason for ART
Indication for use of gestational carrier
Absence of uterus
Significant uterine anomaly
Medical contraindication to pregnancy
Recurrent pregnancy loss (as indication for use of gestational carrier)
Unknown (indication for use of gestational carrier)
Recurrent pregnancy loss
Other reasons related to infertility (specify) |________________________________________________________|
Other reasons not related to infertility (specify) |________________________________________________________|
Unexplained infertility
FEMALE PATIENT HISTORY & PHYSICAL PAGE
Height
|__| Feet (AND/OR) |__|__| Inches (OR) |__|__|__|__| Centimeters (OR)
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

Height unknown
Weight at the start of this cycle
|__|__|__|__| Pounds (OR) |__|__|__|__| Kilograms
(OR)
Weight unknown
Did the patient smoke during the 3 months before the cycle started?
⃝ Yes
⃝ No
⃝ Unknown
Any prior pregnancies?
⃝ Yes
If prior pregnancies reported and couple is not surgically sterile, enter months or years attempting pregnancy since last
clinical pregnancy
|__|__|__| months AND/OR |__|__| years
Number of prior pregnancies |__|__|
Number of prior full term births (live and stillbirths) |__|__|
Number of prior preterm births (live and stillbirths) |__|__|
Number of prior stillborn infants |__|__|
Number of prior spontaneous abortions |__|__|
Number of prior ectopic pregnancies |__|__|
⃝ No
If no prior pregnancies reported and couple is not surgically sterile, enter months or years attempting pregnancy
|__|__|__| months AND/OR |__|__| years
Number of prior stimulations for ART cycles

|__|__|

Number of prior ART cycles started with the intent to transfer oocytes or embryos |__|__|
[IF PRIOR ART AND PRIOR PREGNANCY] Did any of the prior ART cycles result in a live birth?
⃝ Yes
⃝ No
Maximum FSH level (MIU/mls) |__|__|__| . |__|__|
(OR)
FSH level unknown
Date of most recent AMH level (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Most recent AMH level (ng/mL) |__|__|__| . |__|__|
(OR)
AMH level unknown
SOURCES & CARRIERS PAGE
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

OOCYTE SOURCE PROFILE SECTION
Youngest oocyte source
⃝ Patient
⃝ Donor
Oocyte source date of birth (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
(OR)
Age at earliest time oocytes were retrieved |__|__|
Oocyte source ethnicity
⃝ Not Hispanic or Latino
⃝ Hispanic or Latino
⃝ Refused
⃝ Unknown
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)
Reason race not reported
⃝ Refused
⃝ Unknown
PREGNANCY CARRIER PROFILE SECTION
Pregnancy carrier
⃝ Patient
⃝ Gestational carrier
None (oocyte or embryo banking cycle only)
⃝

Pregnancy carrier date of birth (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
(OR)
Age at time of transfer |__|__|
Pregnancy carrier ethnicity
⃝ Not Hispanic or Latino
⃝ Hispanic or Latino
⃝ Refused
⃝ Unknown

(continued next page)
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

SOURCES & CARRIERS PAGE (continued)

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)
Reason race not reported
⃝ Refused
⃝ Unknown

SPERM SOURCE PROFILE SECTION
Specify sperm source (select all that apply)
Partner
Donor
Patient, if male
(OR)
Unknown (select only if all sperm sources unknown)
Sperm source date of birth (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
(OR)
Sperm source date of birth unknown
Sperm source ethnicity
⃝ Not Hispanic or Latino
⃝ Hispanic or Latino
⃝ Refused
⃝ Unknown
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)
Reason race not reported
⃝ Refused
⃝ Unknown
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

STIMULATION & MEDICATIONS PAGE
STIMULATION & MEDICATIONS SECTION
Was there stimulation for follicular development?
⃝ Yes
⃝ No
[If YES, STIMULATION]
Was this a minimal stimulation cycle?
⃝ Yes
⃝ No
Oral medication such as aromatase inhibitor or selective estrogen receptor modulator used
⃝ Yes
Clomiphene dosage (Total mgs) |__|__|__|__|__| . |__|__|
Letrozole dosage (Total mgs) |__|__|__|__|__| . |__|__|
Other oral medication (specify)
|________________________________________________________|
Other oral medical dosage (specify) |__|__|__|__|__| . |__|__|
⃝ No
Medication containing FSH used
⃝ Yes
Short-acting FSH (Total IUs)

|__|__|__|__|__| . |__|__|

Long-acting FSH (Total mgs)

|__|__|__|__|__| . |__|__|

⃝ No
Medication with LH/HCG activity used
⃝ Yes
⃝ No
Primary GnRH protocol used
⃝ No GnRH protocol
⃝ GnRH Agonist Suppression
⃝ GnRH Agonist Flare
⃝ GnRH Antagonist Suppression

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
(continued next page)
STIMULATION & MEDICATIONS PAGE (continued)
CANCELLATION SECTION
Cycle canceled prior to retrieval?
Yes
⃝ No
Date cycle canceled (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Primary reason cycle was canceled
⃝ Low ovarian response
⃝ High ovarian response
⃝ Inadequate endometrial response
⃝ Concurrent illness
⃝ Withdrawal only for personal reasons
⃝ Other (specify) |________________________________________________________|

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

RETRIEVAL PAGE
FRESH OOCYTE RETRIEVAL SECTION
Date retrieval performed (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Number of patient oocytes retrieved |__|__|
Number of donor oocytes retrieved |__|__|
Use of retrieved oocytes (select all that apply)
Used for this cycle
Oocytes frozen for future use
Number of FRESH oocytes frozen for future use |__|__|
Oocytes shared with other patients
Embryos frozen for future use
COMPLICATIONS OF OVARIAN STIMULATION OR OOCYTE RETRIEVAL SECTION Were
there any complications of ovarian stimulation or oocyte retrieval?
⃝ Yes
⃝ No
[IF YES] 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) |________________________________________________________|
Did the complication(s) require hospitalization?
Yes
⃝

⃝ No
SPERM RETRIEVAL SECTION
Sperm status
⃝ Fresh
⃝ Thawed
⃝ Mix of fresh and thawed
⃝ Unknown
Sperm source utilized
⃝ Ejaculated
⃝ Epididymal
⃝

Testis
⃝

Electroejaculation
⃝

Retrograde urine
⃝

Donor
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝

⃝
Unknown

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
MANIPULATION PAGE
Intracytoplasmic sperm injection (ICSI) performed on oocytes?
⃝ All oocytes
Some oocytes
No oocytes
Unknown
[IF ALL OR SOME ICSI] Indication for ICSI (select all that apply)
⃝

Prior failed fertilization
Poor fertilization
PGT
Abnormal semen parameters on day of fertilization
Low oocyte yield
Laboratory routine
Frozen oocyte
Rescue ICSI
Other (specify) |________________________________________________________|
In vitro maturation (IVM) performed on oocytes?
⃝ All oocytes
⃝ Some oocytes
⃝ No oocytes
⃝ Unknown
Pre-implantation genetic testing (PGT) performed on embryos?
⃝ Yes
⃝ No
⃝ Unknown
[IF YES]
Total number of 2PN |__|__|
Reason for PGT (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
Technique used for PGT (select all that apply)
Polar Body Biopsy

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
Blastomere Biopsy
Blastocyst Biopsy
(OR)
Unknown
(continued next page)
MANIPULATION PAGE (continued)

Assisted hatching performed on embryos?
All embryos
Some embryos
⃝ No embryos
⃝ Unknown
Was this a research cycle?
⃝ Yes
⃝ No
[IF YES] Study type (select all that apply)
Device study
Protocol study
Pharmaceutical study
Laboratory technique
Other research (specify) |________________________________________________________|
Approval code |________________________________________________________|

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
TRANSFER PAGE
TRANSFER ATTEMPT SECTION Was
a transfer attempted?
Yes
No
[IF NO] 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) |________________________________________________________|
GENERAL TRANSFER DETAILS SECTION
Date transfer performed (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Most recent endometrial thickness |__|__|mm

FRESH EMBRYO TRANSFER DETAILS SECTION
Number of fresh embryos transferred to uterus |__|__|
If only one fresh embryo was transferred to the uterus, was this an elective single embryo transfer?
⃝ Yes
⃝ No
[FOR EACH FRESH EMBRYO TRANSFERRED TO UTERUS]
Quality of embryo
⃝

Good
⃝

Fair
⃝

Poor
⃝

Unknown

Date of oocyte retrieval (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__| Was
the oocyte used to create this embryo retrieved from a different clinic?
⃝

Yes
⃝

No
If yes, clinic name |_______________________________________________________|
Clinic city |______________________________________________________________|
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
Clinic state |_____________________________________________________________|
Number of fresh embryos cryopreserved |__|__|

(continued next page)

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

TRANSFER PAGE (continued)
FROZEN EMBRYO TRANSFER DETAILS
Number of thawed embryos transferred to uterus |__|__|
If only one thawed embryo was transferred to the uterus, was this an elective single embryo transfer?
⃝ Yes
⃝ No
[FOR EACH THAWED EMBRYO TRANSFERRED TO UTERUS]
Quality of embryo
⃝

Good
⃝

Fair
⃝

Poor
⃝

Unknown

Date of oocyte retrieval (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__| Was
the oocyte used to create this embryo retrieved from a different clinic?
⃝

Yes
⃝

No
If yes, clinic name |_______________________________________________________|
Clinic city |______________________________________________________________|
Clinic state |_____________________________________________________________|

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

GIFT/ZIFT/TET TRANSFER DETAILS SECTION
Number of oocytes or embryos transferred to the fallopian tube |__|__|
OUTCOMES PAGE
OUTCOME OF TRANSFER SECTION
Outcome of treatment cycle
⃝ Not pregnant
⃝ Biochemical
⃝

Clinical intrauterine gestation
⃝

Ectopic
⃝

Heterotopic

⃝ Unknown
[IF CIU OR HETEROTOPIC]
Maximum number of fetal hearts on ultrasound performed before 7 weeks or prior to reduction |__|__| (OR)
No ultrasound performed before 7 weeks gestation or prior to reduction
[IF ULTRASOUND]
Ultrasound date with maximum number of fetal hearts observed before 7 weeks or prior to reduction (mm/dd/yyyy)
|__|__| - |__|__| - |__|__|__|__|

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

Any monochorionic twins or multiples?
⃝ Yes
⃝ No
⃝ Unknown
OUTCOME OF PREGNANCY SECTION
Outcome of pregnancy
⃝ Live birth
⃝ Spontaneous abortion
⃝

Stillbirth
⃝

Induced abortion
⃝

Maternal death prior to birth

⃝ Outcome unknown
Date of pregnancy outcome (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
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
Number of infants born |__|__|
Method of delivery
⃝ Vaginal
⃝ Cesarean
⃝ Unknown
BIRTH PAGE
BIRTH INFORMATION INFANT #1
Infant #1: Birth status
Live born
Stillborn
⃝ Unknown
Infant #1: Gender
⃝ Male
⃝ Female
⃝ Unknown
Infant #1: Weight
|__|__| Pounds AND |__|__| Ounces
(OR)
Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
|__|__|__|__| Grams (OR)
Weight unknown
Infant #1: 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

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
BIRTH INFORMATION INFANT #2
Infant #2: Birth status
⃝ Live born
Stillborn
Unknown
Infant #2: Gender
⃝ Male
⃝ Female
⃝ Unknown
Infant #2: Weight
|__|__| Pounds AND |__|__| Ounces
(OR)
|__|__|__|__| Grams (OR)
Weight unknown
Infant #2: 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
BIRTH INFORMATION INFANT #3
Infant #3: Birth status
⃝ Live born
Stillborn
Unknown
Infant #3: Gender
⃝ Male
⃝ Female

Optional NASS 2.0 Cycle Worksheet v.Jan 2021

⃝
⃝
⃝ Unknown
Infant #3: Weight
|__|__| Pounds AND |__|__| Ounces
(OR)
|__|__|__|__| Grams (OR)
Weight unknown
Infant #3: 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

(this page may be copied for additional infant births)

Optional NASS 2.0 Cycle Worksheet v.Jan 2021


File Typeapplication/pdf
File TitleOptional NASS 2.0 Cycle Worksheet
SubjectOptional NASS 2.0 Cycle Worksheet
AuthorWestat on behalf of the US Department of Health and Human Servic
File Modified2021-02-24
File Created2021-02-24

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