The Need for Informed Consent: The Risks of IVF are Becoming Clearer

Bioethics   |   Steven Ertelt   |   Mar 2, 2010   |   9:00AM   |   WASHINGTON, DC

The Need for Informed Consent: The Risks of IVF are Becoming Clearer

by Mailee Smith
March 2, 2010 Note: Mailee Smith is an attorney for Americans United for Life, a pro-life legal group that focuses on national and state legislative matters.

For decades now, women have been undergoing the process of in vitro fertilization (IVF) without truly knowing the risks that IVF might hold for their health or the health of their children. This is due in significant part to lax informed consent requirements. There are no universal informed consent requirements for facilities where IVF is performed and most states have not enacted comprehensive regulations.

Notably, there is also very little data on the complications arising from IVF, especially for unborn children. We know that the hormones women typically receive during IVF can cause them to develop cancer and other health issues in the future. But the percentage of women affected and its impact on their unborn children, as well as other types of potential complications, are not fully understood.

However, last week Europe’s leading reproductive health medical journal, Human Reproduction, published a study demonstrating that women who become pregnant with a single child (as opposed to multiples) following IVF or intracytoplasmic sperm injection (ICSI) have an increased risk of stillbirth.

The study involved over 20,000 pregnancies between 1989 and 2006—a massive study. After adjusting for all relative factors—such as age, smoking habits, alcohol and coffee intake, and others—it was revealed that women who conceived using IVF or ICSI had a significant four-fold increased risk of stillbirth.

Importantly, the researchers found that this increased risk is not likely due to the underlying infertility issues that drove women to IVF in the first place; rather it is likely due to other factors, such as the technology involved in IVF.

This stunning conclusion begs the question: Do women undergoing IVF know of such risks?

In general, the answer is no. Only one state—Pennsylvania—has meaningful regulation of the IVF industry. And no state requires that women give fully informed consent before undergoing the process.

For example, women (and their partners) need to know that there are major known risks involved with hormone treatment and egg retrieval. But currently, most states do not even require that women be told the likelihood (or unlikelihood, as the case may be) that their IVF procedures will even succeed in producing a viable embryo for transplantation.

What emerges is a state of “business” where those in the IVF industry are luring in already-vulnerable women—women desperate to have children—and failing to inform them of the risks to their own bodies as well as to the health of their potential children. This means that women who have already experienced devastation will potentially be left to deal with another devastating blow: stillbirth.

For the last several years, AUL has advocated that states protect women and their families by passing comprehensive assisted reproductive technology (ART) regulations, including stringent informed consent requirements. A copy of AUL’s model bill is available at

For more information on regulating IVF, please see Preserving Human Dignity: Regulation of Assisted Reproductive Technologies (ART) by Clarke Forsythe in Defending Life 2009.

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