National ART Surveillance System

National ART Surveillance System

NASS 2.0

C1b_v5

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 from autologous oocytes Embryo banking from donor oocytes 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) |__|__|__| . |__|__|, Date (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__| Or AMH level unknown

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) |__|__|__| . |__|__|, Date (mm/dd/yyyy) |__|__| - |__|__| - |__|__|__|__| Or AMH level unknown

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	Most recent 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]

13