Fertility firm pauses marketing of 'three-parent IVF' after STAT probe

The Illinois-based company International Fertility Group of North America has suspended promotion of mitochondrial replacement therapy after an eight-month STAT investigation found that the procedure is being marketed to women in their late 40s and early 50s as a treatment for age-related infertility even though peer-reviewed evidence for that use is sparse.

STAT reported on Monday that it interviewed 45 current and former patients, physicians, clinic operators and researchers, and reviewed private patient communications, business filings, clinic licenses and contracts. The investigation found that IFG, which acts as a medical tourism facilitator rather than a clinic, connected women in the United States and Europe with clinics abroad. Separately, STAT reported that women traveled to clinics in Eastern Europe, Mexico, the Bahamas and the Philippines.

MRT, also called "three-parent IVF," was developed to prevent children from inheriting rare mitochondrial diseases. In the United States it remains effectively illegal because of a congressional spending rider that since 2015 has barred the FDA from reviewing submissions involving embryo modification. Clinics abroad have nonetheless offered it as a fertility add-on for older women, despite the absence of robust trial data. STAT found that the SAGA Clinic in Tirana, Albania, displays an FDA logo on its sign, but an FDA spokesperson said registration in the agency's database of establishments that manufacture human cells does not mean the clinic is licensed or approved.

Why the data are weak

Long-unpublished data from Ukrainian embryologist Pavlo Mazur, who pioneered pronuclear transfer as an infertility treatment before 2016, show the procedure worked poorly in older patients. Of 19 women aged 36 to 44 treated between 2017 and 2019, only one, a 42-year-old, obtained a single embryo with the correct number of chromosomes and delivered a healthy baby boy in 2018. Mazur also ran a reverse experiment using leftover nuclear DNA from young donors inserted into older women's eggs: 40% of resulting embryos developed to the stage where they could be implanted, and of those, 70% had a normal chromosome count. That suggested mitochondrial function was not the limiting factor. His manuscript describing these findings was rejected by journals because patients had not consented to use of leftover eggs and there was no ethics board approval.

Published commercial data have drawn similar criticism. A paper co-authored by embryologist Birol Aydin and physician Uliana Dorofeyeva in The Journal of Reproduction claimed an average live birth rate of 48.3% among 27 advanced maternal age patients, including 33% for women over 42. The journal is not indexed in major repositories, accepted the article within three weeks, and listed Dorofeyeva as an editorial board member; the paper appeared alongside an ad for the authors' egg-banking company Ovogene. A 2025 European Society for Human Reproduction and Embryology conference abstract by the same authors reported live birth rates of 40% or higher in 66 patients with a mean age of 39, but independent experts said it lacked key information such as age subgroups and number of IVF cycles per patient.

The only published peer-reviewed study of mitochondrial donation for infertility, led by Shoukhrat Mitalipov and Nuno Costa-Borges in 2023, reported a 31.6% live birth rate per transfer among 25 patients under age 40 at a clinic in Greece. However, a supplemental breakdown showed that for 12 patients aged 39, the live birth rate was below 10%. Reproductive endocrinologist Mary Herbert of Monash University told STAT that "the actual direct evidence" that mitochondrial dysfunction contributes to the age effect is "very, very sparse."

One patient's path

One former IFG client, a Dutch woman named Wendy, paid more than $30,000 and underwent egg retrievals in Albania and Georgia before 11 of her embryos were moved forward to MRT. Only two reconstructed embryos survived, one was genetically abnormal and the other failed to implant. Aydin told her by text: "We are just assuming you may have mitochondrial issue and we are allowing you to try MRT." Wendy, who was 46 when she became an IFG client, said she had spent her savings and stopped treatment.

Bioethicists expressed concern about paying patients participating in what STAT called a "poorly controlled intergenerational experiment" with unknown long-term effects on children. Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics, said, "You're paying for the privilege of being a guinea pig." IFG said in statements that it is not a medical clinic, does not promise pregnancy or live birth, announced a temporary pause on new MRT patients after STAT began making inquiries in July, and removed MRT mentions from its website last week, calling it "a precautionary communications decision, not a finding on the accuracy of each individual statement you have raised."