Section One: Findings

The [State Body] finds the following:

1. One federal law, the Fertility Clinic Success Rate and Certification Act of 1992, requires the Centers for Disease Control and Prevention to track certain health outcomes and success rates of assisted reproductive technology. Nonetheless, this law lacks a strong enforcement mechanism and is too limited in scope. Additionally, the primary law governing assisted reproductive technology in [State], [Act], does not require fertility clinics to report key data points related to assisted reproductive technology, maternal and neonatal health, and the total number of embryos created through this procedure. As such, many prospective parents, lawmakers, researchers, and fertility clinics lack an adequate understanding of how assisted reproductive technology functions in the [State], information that is essential for prospective parents as they make important decisions about their childbearing options.

Section Two: Definitions

• Human Embryo—The term “human embryo” means a distinct and living organism of the species homo sapiens conceived either in the human body or produced in an artificial environment other than the human body, from the moment of fertilization (including the single-celled stage) until natural death, including such embryos that are in a state of cryopreservation or are otherwise unused.
• Transfer—The term “transfer” means the process by which a medical professional places a fresh or frozen embryo within the uterus, fallopian tubes, or other part of a patient’s body for the purpose of initiating a pregnancy.
• Human Embryo Implantation—The term “human embryo implantation” means a human embryo has successfully attached itself to a patient’s uterine wall lining which marks the beginning of pregnancy.
• Assisted Reproductive Technology—The term ‘‘assisted reproductive technology’’ means any treatments or procedures that involve the handling of a human egg, sperm, and embryo outside of the body with the intent of facilitating a pregnancy, including artificial insemination, intrauterine insemination, in vitro fertilization, gamete intrafallopian fertilization, zygote intrafallopian fertilization, egg, embryo, and sperm cryopreservation, and egg, sperm, or embryo donation.
• Fertility Clinic—The term “fertility clinic” means a medical facility that is licensed, registered, or certified in accordance with the standards put forward by Federal or State laws or regulations and is responsible for the collection and preservation of human reproductive material (including egg, sperm, or embryos) responsible for the creation of human embryos, and/or the placement of human reproductive material (including egg, sperm, or embryo) into the prospective patient.
• Health Care Professional—The term “health care professional” means an individual licensed, registered, or certified under Federal or State laws or regulations to provide health care services.
• Human Reproductive Material—The term “human reproductive material” means all or any part of a sperm, ovum, or embryo at any stage of development.
• Prospective Patient—The term “prospective patient” means the patient who will undergo assisted reproductive technology treatments, including the transfer of human embryos for the purpose of initiating pregnancy.
• Infertility—The term “infertility” means a symptom of an underlying disease or condition within a person’s body that makes it difficult or impossible to successfully conceive and carry a child to term, which is diagnosed after 12 months of intercourse without the use of a chemical, barrier, or other contraceptive method for women under 35 or after 6 months of targeted intercourse without the use of a chemical, barrier, or other contraceptive method for women 35 and older, where conception should otherwise be possible.
• Cycle—The term “cycle” means a single procedure of in vitro fertilization, zygote intrafallopian transfer, gamete intrafallopian transfer, or egg retrieval. A complete cycle may only refer to egg retrieval if no eggs are fertilized and implanted into the patient or it may mean the complete process from egg retrieval to the transfer of human reproductive material.
• Egg Donor—The term “egg donor” means a person unrelated by marriage to the prospective parent(s) who provides or agrees to provide ovum for the purpose of human reproduction, regardless of if the recipient has a diagnosis of infertility.
• Sperm Donor—The term “sperm donor” means a person unrelated by marriage to the prospective parent(s) who provides or agrees to provide sperm for the purpose of human reproduction, regardless of if the prospective parent(s) has a diagnosis of infertility.
• Embryo Cryopreservation—The term “embryo cryopreservation” means that human embryos are frozen in an undisturbed environment for the purpose of saving these embryos for future procreative use.
• Informed Consent—The Term “informed consent” meanswritten and verbal consent obtained from the prospective parent(s) by the fertility clinic, medical association, medical professional, gamete bank, gamete agency, or gamete donation clinic who handles human egg, sperm, or embryo.
• State Board—The term “state board” means the [Department].

Section Three: Prohibition Section

Overview

This law should be adopted and enacted by the [Department], either within the existing [Act] or within another statute that ensures the best enforcement and data collection mechanisms for this law.

Section Four: Assisted Reproductive Technology Clinic Reporting Requirements

• [State Body] directs the [Department] to expand fertility clinic reporting requirements for assisted reproductive technology. Annually, fertility clinics must track and report key data points to the appropriate state department for research and accountability purposes. These data points include:
  • How many embryos each clinic creates in total through assisted reproductive technology cycles;
  • What happens to each of the embryos they create:
  • How many embryos (at any stage of development) are negligently destroyed each year due to the failure of a cryopreservation tank or technical and human error;
  • How many embryos (at any stage of development) perish due to natural causes during fertilization, development, or implantation in assisted reproductive technology;
  • How many embryos (at any stage of development) perish due to preimplantation genetic testing in assisted reproductive technology;
  • How many embryos (at any stage of development) are intentionally destroyed at the discretion of the fertility clinic or the prospective parents;
    • Require fertility clinics to specify, by selecting one of the four following options, why the fertility clinic and/or parents chose to discard the embryo: a) genetic or physical health concerns; b) wrong biological sex; c) unwanted or unused embryo; or d) other (provide reason).
  • How many embryos (at any stage of development) prospective parents relinquished to an embryo adoption clinic;
  • How many embryos (at any stage of development) prospective parents donate for research purposes;
  • How many embryos are created in each cycle of assisted reproductive technology (i.e. when a couple undergoes in vitro fertilization procedures, how many embryos are created in one cycle?)
  • If, and how often, fertility clinics lose the reproductive material of prospective parents due to unknown or undisclosed reasons;
  • Report any instances of a medical professional knowingly transferring non-viable reproductive material into a prospective patient, with or without the patient’s knowledge;
  • The total number of embryos that are frozen in cryopreservation storage units (submit the number of embryos frozen prior to submitting the report each year, whenever that occurs);
  • How many embryos are transferred fresh versus frozen;
  • How many embryos are transferred in a single transfer cycle;
  • How many embryos successfully implant, when conceived with assisted reproductive technology, but are miscarried, perish naturally in the womb, or are stillborn;
  • How many pregnancies result from assisted reproductive technology procedures;
  • How many live births result from assisted reproductive technology procedures;
  • How many cases of multiple gestation (twins, triplets, quadruplets, or more) occur from assisted reproductive technology procedures.

Section Five: Assisted Reproductive Technology Annual Public Report

• Within twelve months of receiving the annual assisted reproductive technology data from fertility clinics, the [Department] must compile and publish a comprehensive report, available for public use, cataloging key data points for research, accountability, and prospective patient use. These data points include:
  • How many fertility clinics are registered to practice assisted reproductive technology;
  • How many assisted reproductive technology and egg retrieval cycles each clinic performs;
  • A percentage breakdown of the types of assisted reproductive technology procedures clinics (taken as a whole) perform;
  • The success rate of each form of assisted reproductive technology, broken down by age, whether donor ovum or sperm was used, and the total number of cycles required for the successful birth of a live child per couple;
  • Compile and report the total outcomes of each of the individual fertility clinic data collection points from Section Four: Assisted Reproductive Technology Clinic Reporting Requirements.

Section Six: Maternal and Neonatal Health Outcomes Related to Assisted Reproductive Technology

• In conjunction with the [Department], the [State Body] directs the [Department] to track and report maternal health outcomes throughout pregnancy, labor, and the postpartum period (a minimum of eighteen months) for women who conceive, or bear through gestational surrogacy, children with assisted reproductive technology.
• In conjunction with the [Department], the [State Body] directs the [Department] to track and report neonatal health outcomes (including birth defects, diseases, genetic or physical conditions, chronic issues, physical abnormalities, mental health, or other health factors) of children conceived with assisted reproductive technology, including an implementation of an ongoing review of a child’s genetic, physical, and emotional health until the age of eighteen. [Given potential privacy concerns, a self-reporting option may be offered].

Section Seven: Severability Clause

If any provision of this Act, or the application of such provision to any person, entity, government, or circumstance, is held to be unconstitutional, the remainder of this Act, or the application of such provision to all other persons, entities, governments, or circumstances, shall not be affected thereby.