[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Notices]
[Pages 59625-59627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Reporting of Pregnancy Success Rates From Assisted Reproductive 
Technology (ART) Programs; Clarifications and Corrections

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), announces 
clarifications for and correction to certain data collection fields, 
terminology, and definitions used for reporting of pregnancy success 
rates from assisted reproductive technology (ART) programs. This 
reporting is required by the Fertility Clinic Success Rate and 
Certification Act of 1992 (FCSRCA).

[[Page 59626]]


DATES: These clarifications and corrections will be implemented January 
1, 2020.

FOR FURTHER INFORMATION CONTACT: Jeani Chang, Division of Reproductive 
Health, National Center for Chronic Disease Prevention and Health 
Promotion, Centers for Disease Control and Prevention, 4770 Buford 
Highway, MS-C107-2, Atlanta, Georgia 30341. Phone: (770) 488-6355. 
Email: [email protected].

SUPPLEMENTARY INFORMATION: On August 26, 2015, HHS/CDC published a 
notice in the Federal Register (80 FR 51811) announcing the overall 
reporting requirements of the National ART Surveillance System (NASS). 
The notice described who shall report to HHS/CDC; the process for 
reporting by each ART program; the data to be reported; and the 
contents of the published reports. This current notice, published 
November 5, 2019, includes clarifications for some variables and 
definitions to improve quality of data. Corrections were made to align 
with current terminology. These clarifications and corrections will be 
helpful by clarifying reporting requirements in certain unique 
situations and updating terminology to align with current practice. 
This notice includes the current guidance and definitions that will be 
implemented starting January 1, 2020.

Clarifications and Corrections

Section II. When and How To Report

Section A. Reporting Activities
    Current: All cycle data must be reported prospectively, i.e., 
reporting of initial cycle intent and select patient details is 
required within four days of cycle initiation.
    Clarification (to improve the quality of data by clarifying 
prospective reporting requirements for natural cycles and frozen 
cycles; effective January 1, 2020): All cycle data must be reported 
prospectively, i.e., reporting of initial cycle intent and select 
patient details is required: (a) At least one day prior to oocyte 
retrieval for all natural cycles using fresh embryos created from fresh 
eggs; (b) at least one day prior to thaw for all frozen oocyte or 
frozen embryo cycles; and (c) within four days of cycle initiation for 
all other cycles.
Section B. Cycle Information
    Current: Intended banking type (Embryo banking, autologous oocyte 
banking, donor oocyte banking).
    Clarification (to differentiate oocyte source for banking cycles; 
effective January 1, 2020): Intended banking type (Embryo banking from 
autologous oocytes, embryo banking from donor oocytes, autologous 
oocyte, donor oocyte).
Section C. Patient History
    Current: Number of Prior ART cycles (Fresh & Frozen).
    Clarification (to clarify question applicability; effective January 
1, 2020): Number of Prior ART cycles started with the intent to 
transfer oocytes or embryos.
Section F. Stimulation and Retrieval
    Current: Date of retrieval.
    Clarification (to clarify the definition for different treatment 
protocols; effective January 1, 2020): In general, each retrieval 
should be reported as its own cycle. This includes egg retrievals for 
fertility preservation cycles (e.g., for cancer patients). In the case 
of continuous stimulation or dual stimulation to maximize the number of 
eggs retrieved in the shortest possible time, the cycle start date for 
the subsequent retrieval will be the day that stimulation medication 
was restarted after the trigger was administered for the previous egg 
retrieval; if the stimulation medication was never stopped, stimulation 
start will be the day after the previous egg retrieval.
    If a patient is having a second egg retrieval due to a ``failed 
trigger'' (i.e., patient medication administration error or poor 
response to the trigger that results in unexpectedly low number of 
eggs), the second trigger and retrieval date would be used for 
reporting as part of the first cycle. In this case, the interval 
between the first and second retrieval should not exceed 2 days. If the 
interval exceeds 2 days, each retrieval should be entered as its own 
cycle.
Section G. Laboratory Information
    Current:

Indication for ICSI (Prior failed fertilization, Poor fertilization, 
PGD or PGS, Abnormal semen parameters, Low oocyte yield, Laboratory 
routine, Frozen cycle, Rescue ICSI, Other)
PGD (Pre-implantation genetic diagnosis) or screening (PGS)
Reasons for PGD or PGS
Technique used for PGD or PGS

    Correction (to update the terminology for preimplantation genetic 
testing; effective January 1, 2020):

Indication for ICSI (Prior failed fertilization, Poor fertilization, 
PGT, Abnormal semen parameters, Low oocyte yield, Laboratory routine, 
Frozen cycle, Rescue ICSI, Other)
PGT (Pre-implantation genetic testing)
Reasons for PGT
Technique used for PGT
Section H. Transfer Information
    Current: Endometrial Thickness Prior to Embryo Transfer.
    Clarification (to clarify the timing of measurement; effective 
January 1, 2020): Most Recent Endometrial Thickness.
Section J. Definitions
    Current: Cycle start date (cycle initiation date)--
    (1) For fresh embryo (both donor and nondonor): The first day that 
medication to stimulate follicular development is given in a stimulated 
cycle or the first day of menses in an unstimulated cycle. For example:
    a. The first day of gonadotropins in a gonadotropin only cycle or 
in a long suppression GnRH agonist-gonadotropin cycle;
    b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
    c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
    d. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    (2) For fresh embryo donor cycles:
    a. The first day exogenous sex steroids are given to patient to 
prepare the endometrium;
    b. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    (3) For frozen embryo cycles (both donor and non-donor):
    a. The first day exogenous sex steroids are given to prepare the 
endometrium;
    b. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    (4) For oocyte/embryo banking cycles:
    a. The first day of gonadotropins in a gonadotropin only cycle or 
in a long suppression GnRH agonist-gonadotropin cycle;
    b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
    c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
    d. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    Clarification (to clarify the definition for different types of 
cycles; effective January 1, 2020): Cycle start date (cycle initiation 
date)--
    (1) For cycles using fresh embryos created from fresh nondonor 
eggs: The first day that medication to stimulate follicular development 
is given in a stimulated cycle or the first day of menses in an 
unstimulated cycle. For example:
    a. The first day of gonadotropins in a gonadotropin only cycle or 
in a long

[[Page 59627]]

suppression GnRH agonist-gonadotropin cycle;
    b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
    c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
    d. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    (2) For cycles using fresh embryos created from fresh donor eggs:
    a. The first day exogenous sex steroids are given to patient to 
prepare the endometrium;
    b. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    (3) For cycles using frozen eggs or frozen embryos (both donor and 
non-donor):
    a. The first day exogenous sex steroids are given to prepare the 
endometrium;
    b. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    (4) For oocyte/embryo banking cycles:
    a. The first day of gonadotropins in a gonadotropin only cycle or 
in a long suppression GnRH agonist-gonadotropin cycle;
    b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
    c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
    d. The first day of natural menses or withdrawal bleeding in an 
unstimulated cycle.
    Current: Preimplantation genetic diagnosis (PGD)--Characterization 
of a cell or cells from preimplanted embryos from IVF cycles to 
determine the presence or absence of a specific genetic defect.
    Preimplantation genetic screening (PGS)--Characterization of a cell 
or cells from preimplanted embryos from IVF cycles to identify genetic 
abnormalities.
    Correction (to update the terminology; effective January 1, 2020): 
Preimplantation genetic testing (PGT)--Testing performed to analyze DNA 
from oocytes or embryos for determining genetic abnormalities, 
including aneuploidies (PGT-A), monogenic/single gene defects (PGT-M), 
and chromosomal structural rearrangements (PGT-SR).

    Dated: October 30, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-24043 Filed 11-4-19; 8:45 am]
BILLING CODE 4163-18-P