Mitochondrial replacement therapy (MRT), commonly known as “three-parent IVF,” was developed to reduce the risk of mothers passing certain mitochondrial diseases to their children. It is now being marketed by fertility companies and overseas clinics as an option for older women, even though researchers say there is little evidence that it improves fertility in this group.

An eight-month investigation by STAT found that hundreds of women from the United States and Europe have traveled to clinics in countries including Albania, Ukraine, Georgia, Mexico, the Bahamas and the Philippines to undergo the procedure. The treatment is illegal in the United States, and an Illinois-based company, International Fertility Group of North America (IFG), has connected patients with clinics abroad.

The investigation identified incomplete data, questionable record keeping and limited publication of results in established peer-reviewed journals. Researchers and reproductive specialists interviewed by STAT said the available evidence does not support claims that MRT can overcome the main causes of age-related infertility, which often involve factors other than mitochondrial function.

IFG has promoted MRT as a way to improve the “energy” of older eggs by replacing their mitochondria with those from a donor egg. Its website previously claimed that 34 babies had been born through its mitochondrial donation program as of February 2025 and cited a pregnancy rate above 50% for IVF cycles involving MRT, without providing supporting evidence or results broken down by age.

The company’s average patient age rose from 39.2 in 2022 to 45.6 the following year, according to a slide presented during an IFG webinar. Social media posts described MRT as a potential solution for women in their late 30s, 40s and beyond, including those who had experienced failed IVF cycles. Some of those posts were removed after STAT asked the company about them.

Wendy, a Dutch woman who requested that only her first name be used, paid more than $30,000 for treatment after turning to MRT in hopes of having another genetically related child. At 46, she traveled several times to clinics in Albania and Georgia for egg retrievals and ultimately had an embryo created using genetic material from her, her partner and a Ukrainian egg donor. The embryo transfer did not result in a pregnancy.

She said she understood the procedure to offer a chance of improving the performance of older eggs through the use of younger donor mitochondria. Before proceeding, however, she knew that published statistics were lacking. “If I had the time I would have waited for the statistics to be published,” she said. “In my case, I could not afford to wait. I was 46. It was now or never.”

Other former clients told STAT that they did not obtain viable embryos, stopped treatment after becoming concerned about the quality of care abroad, or underwent the procedure without achieving a pregnancy. A fertility specialist who said she had referred about 50 older patients to IFG and two clinics performing MRT reported that she had not yet seen a successful outcome among them, although she remains hopeful about the technology.

Experts also raised concerns about the limited oversight of the international treatment network and the consequences for children born through MRT. STAT reported examples of incomplete documentation and an unexplained ancestry-test result that raised questions about the source of a child’s DNA. Some scientists believe MRT could eventually have a role in fertility care, but they want it evaluated through rigorous research before it is offered broadly to paying patients.

Heidi Mertes, a medical ethicist at Ghent University who reviewed IFG’s promotional materials, said MRT was being presented as established medicine despite the absence of published evidence showing that it works for women over 40. Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics, described the current model as asking patients to pay to participate in an inadequately controlled experiment.

IFG said it is not a licensed medical clinic and does not perform medical procedures. In a written response, the company said patients should receive clear information about risks, uncertainties, alternatives and limitations, and maintained that it does not promise pregnancy, live birth or any specific outcome.

After STAT began asking questions, IFG announced a temporary pause on accepting new MRT patients. The company later removed references to MRT from its website and said it was suspending related promotion while conducting a comprehensive review, describing the move as a precautionary communications decision rather than a finding about the accuracy of individual claims.

Sources: STAT News.