Clinics Market “Three-Parent IVF” to Older Women Despite Little Evidence It Works

Women in their late 30s, 40s, and early 50s are traveling thousands of miles and paying $20,000 to $30,000 or more for an experimental procedure marketed as a way to help them have a baby with their own DNA. A recent investigation by STAT News found that clinics and brokers are pitching “three-parent IVF” to older women as a solution for age-related infertility, even though leading scientists say there is little proof that the procedure works for that purpose.

The technique was originally created to prevent mothers from passing on rare genetic diseases in their mitochondria to their children that can sometimes be fatal. The procedure takes the main genetic material from the intended mother’s egg and puts it into a donor egg that has had its own main genetic material removed. The resulting child has DNA from the mother and father, plus a small amount of DNA from the egg donor.

The procedure is effectively banned in the United States since Congress prohibited the FDA from considering clinical trials in 2015. An Illinois company called International Fertility Group is working around the domestic ban by connecting American and European women to clinics in other countries, including Albania.

STAT News reports the company claimed on its website that 34 babies were successfully born through its program, with clients ranging in age from 39 to 52 and a 54% pregnancy success rate. The company reportedly took down the claims after receiving inquiries from STAT News asking it to substantiate its claims with evidence. IFG said it receives the information from partner clinics, but STAT News spoke with SAGA Clinic, IFG’s primary partner clinic, and they said that data isn’t collected and there is no way to gather that data after patients leave the facility.

IFG’s Facebook page states that “fertility changes with age, but age is only one piece of the puzzle.” It continues, “Many women become mothers in their 40s, naturally or with the help of fertility treatment. The most important thing is understanding your individual situation and knowing your options.”

The company’s Facebook page also brings attention to the case of actress Cameron Diaz, who gave birth to her three children at age 47, 51, and 53. “More women today are becoming mothers later in life through different paths, different technologies, and different personal journeys,” the company wrote. “Stories like Cameron Diaz remind people that family building no longer follows one timeline. Modern reproductive medicine has opened new possibilities for intended parents worldwide — from IVF and donor programs to surrogacy and advanced fertility treatments. Because becoming a parent should not be defined only by age.”

Diaz has not provided any details about any reproductive treatment she may have received that allowed her to give birth to a child at the age of 53.

Scientists who have studied the technique told STAT News that most age-related fertility problems are not caused by worn-out mitochondria. They come from other issues in older eggs, especially problems with chromosomes. A published study involving women under 40 showed high success rates, but when researchers evaluated the data for only women who were 39 years old, the live-birth rate dropped below 10%. An embryologist who provided the procedure at a Ukrainian clinic later said the procedure rarely helped older women. He said clinics continuing to sell the procedure are misleading patients.

Researchers have found potential safety concerns related to the procedure when it is used for its original purpose of preventing mitochondrial disease. The purpose of the procedure is to minimize the amount of the mother’s mitochondria that passes on to the child, but in some cases the small amount of mitochondria from the mother multiplies to be as high as 72% of the mitochondria, which is considered a failure in terms of protecting the child from mitochondria disease.

The HighWire has reported about other documented problems with standard IVF treatments. Dr. Naomi Whitaker told The HighWire last year that IVF is experimental therapy. “This is not something that we know the long-term health and safety outcomes of the offspring,” Dr. Whitaker said. “And we know there’s a high death rate of the offspring. Starting at not only the embryo stage, but during each trimester of pregnancy, we know there’s a high loss of life of embryos and fetuses. So stillbirth is increased across every single trimester. Birth defects are increased in these children, including preterm births and cancers. The further you look at the data – three months, six months, five years – the more you find that these people have cancers as well.”

Clinics typically extract 10-15 eggs for one IVF treatment with about 80% becoming viable embryos. In 2022, there were over 250,000 patients according to the CDC. Estimates suggest there are between 1.5 million and 1.8 million embryos created each year for IVF treatments that are never born.

STAT News has close ties with the biotech and pharmaceutical industries and is often criticized for reporting about developments in a way that aligns with the industry. The outlet reports that 38% of its audience works in the biotech sector and has featured partnerships with Pfizer, Genentech, Phrma, and other pharmaceutical companies.