After Katie had two miscarriages and an ectopic pregnancy, she started exploring assisted reproductive treatments. She found a clinic in the Bay Area, and after her second cycle of in vitro fertilization, she was overjoyed when she learned that she was pregnant. But at 12 weeks, she had another miscarriage.
Determined to increase her chances, Katie — who asked to use just her first name to protect her family’s privacy — started researching immunotherapies in IVF. For most people, this involves taking oral medications daily, which suppress the immune system. It’s an off-label use of the drugs typically administered to treat cancer patients, people with thyroid disorders, and those with severe autoimmune disorders.
Immunotherapy is just one of a number of “add-on” treatments, introduced to supplement standard IVF treatments, which some reproductive clinics now offer couples who are struggling with infertility.
Eager to give the nascent procedure a shot, Katie flew to New York to meet with a doctor who specializes in these types of treatments.
Desperate couples are seeking out IVF ‘add-on’ treatments
Katie’s first cycle after receiving this treatment resulted in a chemical pregnancy that she ultimately lost.
Since the summer of 2018, Katie and her husband have spent more than $20,000 on add-on treatments. That’s on top of standard IVF costs, which run about $20,000 a cycle in the US.
Researchers say there isn’t enough evidence to support the use of add-on treatments
Katie said she has approached the process with a “healthy amount” of skepticism, but trusts that these supplemental treatments could be the key to her finally having a baby. She’s not concerned about any potential adverse health risks, just about whether she’s being financially responsible.
Some reproductive experts believe that there’s reason for concern.
A series of research papers published on Tuesday in the latest issue of the medical journal “Fertility and Sterility” suggest that there is no evidence to show that common “add-on” treatments during an in vitro fertilization cycle could increase the likelihood of getting pregnant. In fact, such treatments may come with real health concerns, and could perhaps interfere with a woman’s chances of seeing two pink lines on a pregnancy test.
These treatments may even interfere with getting pregnant
Many of these add-ons are not offered in traditional fertility clinics. They’re found in clinics that focus on more experimental treatments that have not been fully-vetted by randomized clinical trials and peer-reviewed papers, which are the gold standard of medical research.
“There aren’t good studies out there to say that [add-on treatments] help pregnancy rates,” William Schoolcraft, founder and medical director at CCRM Fertility, told Insider. “Patients are hungry. But I’m here to say: The science says it’s not helpful, so I don’t think that’s in your best interest.”
Researchers behind the new studies looked at five categories of add-on treatments: Immune therapies, endometrial scratching, endometrial receptivity array, uterine artery vasodilation, and intrauterine hCG. While it’s understandably tempting for eager patients to sign on for extra procedures, the researchers warn that they shouldn’t be treated like innocuous menu items.
Any time an extra drug or procedure is introduced, so are additional risks.
“Use of any drugs or techniques carried out in addition to the standard process carry a potential risk, both to the woman and a developing fetus,” said Sarah Lensen, a researcher specializing in infertility in the department of Obstetrics and Gynaecology at the University of Auckland, and co-author of several of these new studies.
Supporters of add-on treatments say patients can’t afford to wait for robust evidence
The risks are especially great if the procedure involves manipulation to the embryo or is a medication being administered into early pregnancy.
Jack Wilkinson, another co-author of these new studies, said that the IVF industry often defends these new procedures, and says that patients can’t afford to wait for robust evidence to prove their efficacy.
“These ‘right to try’ arguments sound good if you think of the worst case scenario as being that the add-on doesn’t work,” Wilkinson said. “In reality, it is possible that an unproven treatment will actually reduce the chances of having a baby, or otherwise cause harm to the mother or any children born as a result.”
Eric Forman, a reproductive endocrinologist and medical and laboratory director at Columbia University Fertility Center in New York, agrees that most add-ons are “outside the mainstream.”
When it comes to prescribing treatments, he emphasizes that he only encourages methods that are “proven” to help couples struggling with infertility.
He said there’s a lack of data for the use of immunotherapy to promote IVF success. A group opinion published last year by the American Society for Reproductive Medicine also concluded that there was no evidence to support the use of immunotherapy in IVF.
Still, Forman said he wouldn’t lump all five add-ons analyzed in the reports into one category.
A procedure called endometrial receptivity array testing may help
Forman actually offers his patients endometrial receptivity array (ERA) testing. It is the only procedure from the list of add-ons discussed in the papers that he provides, and the one most likely to be offered by more mainstream practitioners.
The ERA test involves an endometrial biopsy. Based on the results, a clinician might opt to extend a woman’s dosing of progesterone, the hormone that is necessary for the uterine lining to sustain and hold a pregnancy, before transfer.
Endometrial biopsy itself is a safe and well-tested procedure. The ERA test may offer patients with recurrent failed cycles more information on how best to time their embryo transfers. It may be especially helpful for older patients who might have a decreased time frame for achieving pregnancy.
A 40-year old Pennsylvania woman, who asked to remain anonymous in order to protect her family’s privacy, underwent ERA testing this month after enduring more than five years of failed IVF cycles and miscarriages. She learned about the test after asking her fertility doctor if there was anything else to possibly do to achieve pregnancy — either traditional or experimental.
“We’ve become so desperate,” the woman told Insider. “Now it feels like, whatever’s out there we will do unless there is a great risk in any way.”
She hopes to try another embryo transfer in December. This time, she’ll have the results from her ERA testing, which cost $750.
When patients come to Schoolcraft with similar pleas, he counsels them to use an abundance of caution.
While Schoolcraft knows it’s frustrating to hear, he often tells them that the best thing to do is to remain patient.
“Sometimes, repeating a cycle is all you need to do,” Schoolcraft said. “You have a different crop of eggs, different sperm. It’s a different month.”