Form 0920-0556 National ART Surveillance System (NASS)

Assisted Reproductive Technology (ART) Program Reporting System

Att C1. NASS Data collection

National ART Surveillance System

OMB: 0920-0556

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NASS 2.0 Log-in Web Page

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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

Cycle start date|__|__| - |__|__| - |__|__|__|__|
RESIDENCY SECTION
At the start of cycle, is patient residency primarily in U.S.?
⃝

Yes
⃝

No
⃝

Refused

U.S. city of primary residence |________________________________________________________|
U.S. state of primary residence |_______________________________________________________|
U.S. zip code of primary residence |____________________________________________________|
Country of primary residence |_________________________________________________________|
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 BANKING] Banking type (select all that apply)
Embryo banking
Autologous oocyte banking
Donor oocyte banking
[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
NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

[IF AUTOLOGOUS AND/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
[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 donor embryos
FROZEN donor embryos
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)

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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 donor embryos
FROZEN donor embryos

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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
Other male factor (specify) |________________________________________________________|
History of endometriosis
Tubal ligation for contraception
Current or prior hydrosalpinx
Communicating
Occluded
Unknown
Other tubal disease (not current or prior hydrosalpinx)
Ovulatory disorders
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
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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

FEMALE PATIENT AND HISTORY PAGE
Height
|__| Feet (AND/OR) |__|__| Inches (OR) |__|__|__|__| Centimeters
(OR)
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 yes, and couple is not surgically sterile, enter months and/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 stillbirths |__|__|
Number of prior spontaneous abortions |__|__|
Number of prior ectopic pregnancies |__|__|
⃝

No
If no, and couple is not surgically sterile, enter months and/or years attempting pregnancy
|__|__|__| months AND/OR |__|__| years

Number of prior stimulations for ART cycles

|__|__|

Number of prior frozen ART cycles |__|__|
[IF PRIOR ART] Did any 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
NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

SOURCES & CARRIERS PAGE
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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

STIMULATION & MEDICATIONS PAGE
STIMULATION & MEDICATIONS SECTION
Was there stimulation for follicular development?
⃝

Yes
⃝

No

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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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) |________________________________________________________|

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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
⃝

Unknown

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

MANIPULATION PAGE
Intracytoplasmic sperm injection (ICSI) performed on oocytes?
⃝

All oocytes
⃝

Some oocytes
⃝

No oocytes
⃝

Unknown
[IF 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) |________________________________________________________|

In vitro maturation (IVM) performed on oocytes?
⃝

All oocytes
⃝

Some oocytes
⃝

No oocytes
⃝

Unknown

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

Yes
⃝

No
⃝

Unknown
[IF PGD/PGS]
Total number of 2PN |__|__|
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
Technique used for PGD or PGS (select all that apply)
Polar Body Biopsy
Blastomere Biopsy
Blastocyst Biopsy
(OR)
Unknown

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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 |________________________________________________________|

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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) |__|__| - |__|__| - |__|__|__|__|
Endometrial thickness at trigger |__|__|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

Quality of embryo #1
⃝

Good
⃝

Fair
⃝

Poor
⃝

Unknown

Date of oocyte retrieval for embryo #1 (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Quality of embryo #2
⃝

Good
⃝

Fair
⃝

Poor
⃝

Unknown

Date of oocyte retrieval for embryo #2 (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Number of fresh embryos cryopreserved |__|__|

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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

Quality of embryo #1
⃝

Good
⃝

Fair
⃝

Poor
⃝

Unknown

Date of oocyte retrieval for embryo #1 (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Quality of embryo #2
Good
⃝

Fair
⃝

Poor
⃝

⃝

Unknown

Date of oocyte retrieval for embryo #2 (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__|
Number of thawed embryos cryopreserved (re-frozen) |__|__|
GIFT/ZIFT/TET TRANSFER DETAILS SECTION
Number of oocytes or embryos transferred to the fallopian tube |__|__|

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

OUTCOMES PAGE
OUTCOME OF TRANSFER SECTION
Outcome of treatment cycle
⃝

Not pregnant
⃝

Biochemical
⃝

Clinical intrauterine gestation
⃝

Ectopic
⃝

Heterotopic
⃝

Unknown

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)
|__|__| - |__|__| - |__|__|__|__|
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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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)
|__|__|__|__| 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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017

BIRTH INFORMATION INFANT #3
Infant #3: Birth status
⃝

Live born
⃝

Stillborn
⃝

Unknown

Infant #3: Gender
⃝

Male
⃝

Female
⃝

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

NASS 2.0 Cycle Variables (RY16-17)

v.Sept 2017


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