Section One: Findings

The [State Body] finds the following:

1. The American Society for Reproductive Medicine, one of the largest fertility organizations in the United States, offers non-legally enforceable recommended guidelines encouraging fertility clinics to practice single embryo transfers in assisted reproductive technology, except in extenuating circumstances for older patients.
2. The American Society for Reproductive Medicine and the broader medical community are committed to promoting, where preemptively possible, singleton pregnancies in the best interests of the mother and neonatal child.
3. Multiple gestation (the conception of twins, triplets, quadruplets, or more) leads to an increased risk of poor maternal and neonatal health outcomes. These risks, compared to singleton pregnancies, result in a higher percentage of preterm labor and birth; severe maternal outcomes including death, transfer to an intensive care unit, blood transfusions, and hysterectomy; gestational hypertension; anemia; birth defects including congenital abnormalities such as neural tube defects, gastrointestinal, and heart abnormalities; miscarriage; cesarian delivery; and postpartum hemorrhage. These conditions threaten the health and safety of the mother and/or the child.
4. While the rates of multiple gestation have decreased in recent years, the percentage is substantially higher in assisted reproductive technology than among natural conception pregnancies. This led researchers to conclude that many fertility clinics, to increase success rates, continue to transfer more than one embryo in a single transfer cycle, to the detriment of mothers and children.
5. Unlike the United States, European nations tend to have well-established laws governing the practice of assisted reproductive technology, specifically addressing how many embryos may be transferred in a transfer cycle. For example, Australia and New Zealand limit the number of embryos that may be transferred at one time to 1-2, depending on circumstances; Germany limits the number to 3 or fewer embryos that may be transferred at one time, and Sweden limits the number of embryos that may be transferred at one time to 1, or 2 in special cases.

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 recipient who provides or agrees to provide ovum for the purpose of human reproduction, regardless of if the recipient 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.

Section Three: Prohibitions 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: Informed Consent

1. Prior to the collection of human reproductive materials and the use of assisted reproductive technology, the prospective patient should receive informed consent about the number of embryos that may be transferred in each cycle given the woman’s age.
2. The prospective patient should also provide informed consent, regardless of their age, about the maternal health risks and neonatal concerns related to assisted reproductive technology. This should include data specific to in vitro fertilization maternal and neonatal outcomes and maternal and neonatal health risks associated with transferring multiple embryos in a single transfer cycle.
3. The prospective patient should also receive informed consent about the status and cryopreservation of unused embryos in between each transfer cycle.

Section Five: Transfer Cycle Age Requirements

1. For the prospective patient aged 37 years or younger, a medical professional in assisted reproductive technology may only transfer a single embryo per each transfer cycle, regardless of the embryo’s development stage. This applies to the age of the prospective patient who is receiving the transfer, not the age of the human eggs involved if the prospective patient relies on donor eggs.
2. For the prospective patient aged 38 years or older, a medical professional in assisted reproductive technology may only transfer a maximum of 3 embryos per each transfer cycle, regardless of the embryo’s developmental stage. This applies to the age of the prospective patient who is receiving the transfer, not the age of the human eggs involved if the prospective patient relies on donor eggs.

Section Six: 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.