Form C1b_v2 Att C1b v2 (Proposed) Future NASS screens for 2016

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		U.S. state of primary residence: City of primary residence U.S. zip code at primary residence |__|__|__|__|__| OR 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? ⃝Yes ⃝ No [IF NO STIMULATION OR FROZEN CYCLE, SKIP #36-39]
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