Watchdog to Fertility Clinics: Drop Unproven ‘Add‑Ons’ — The Evidence Patients Should Demand Before Paying More

NICE’s draft update draws a bright line between proven core care and expensive optional extras. The committee advises against several of the sector’s most popular upsells: endometrial scratching; routine hysteroscopy solely to improve IVF outcomes; endometrial receptivity testing before embryo transfer; and ICSI where semen parameters are normal. The message is to focus on interventions that consistently improve live births in defined patient groups, not on techniques that are biologically plausible but insufficiently supported by rigorous evidence.

The guidance also elevates informed consent. Clinics should provide individualized estimates of success and discuss both risks and benefits before any non‑core intervention. That includes the practical burden of timing, cycle disruptions, extra procedures, and the opportunity costs of diverting budget from core steps known to improve outcomes.

Access and value are addressed head‑on. The committee found that, for eligible patients, up to three full IVF cycles can represent good value, though funding decisions remain in the hands of local integrated care boards. By focusing public and private budgets on evidence‑based care, NICE is implicitly challenging the economic logic of selling marginal or unproven add‑ons that consume resources without reliably increasing live births.

There is also a broader definition of fertility preservation. While traditionally centered on oncology, NICE suggests widening access to people at medical risk of losing fertility, such as those with severe recurrent endometriosis or after surgeries affecting reproductive organs. That reframing recognizes the importance of timing—and the ethical obligation to align interventions with credible, patient‑centered benefits.

Endometrial scratching is a case study in evidence whiplash. A large pragmatic multicentre randomized trial published in 2019 found no difference in live births versus no intervention among 1,364 women undergoing IVF. That single, high‑quality trial carries weight because it measured the outcome that matters most to patients: live birth. Yet an individual participant data meta‑analysis published in 2023, pooling over 4,000 participants after extensive data integrity checks, reported a modest improvement in live‑birth odds overall and suggested that timing may influence effectiveness. Crucially, it failed to identify any subgroup—by age, prior failures, treatment type, or infertility cause—with a consistently greater benefit, and it explicitly recommended caution and robust counseling.

Endometrial receptivity testing (ERA and similar transcriptomic assays) also draws heavy marketing but rests on mixed evidence. A 2023 systematic review and meta‑analysis underscored ongoing uncertainty about whether personalizing transfer timing based on molecular signatures improves pregnancy or live‑birth outcomes. Large randomized trials in first‑cycle patients and in recurrent implantation failure populations have been registered; definitive live‑birth‑focused results in unselected patients are still pending. On current evidence and per NICE’s draft stance, ERA should not be routine.

Pre‑IVF hysteroscopy as a generic “optimization” tool is not supported. While hysteroscopy is invaluable when there is a specific clinical indication (for example, suspected intrauterine pathology), randomized work in women without sonographic abnormalities has not demonstrated improved outcomes when used solely as a pre‑treatment add‑on. NICE accordingly advises against it for that purpose, reducing unnecessary invasiveness and anesthesia exposure.

ICSI in non‑male factor infertility is another example where practice drift has outpaced proof. ICSI revolutionized care for severe male factor cases, but routine use in cycles with normal semen parameters adds cost and laboratory complexity without evidence of better live‑birth outcomes in this group. Large randomized trials comparing ICSI with conventional IVF in couples without male factor have completed internationally with enrollments exceeding 1,000 and 2,000 participants; the totality of current guidance points away from defaulting to ICSI when there is no male factor indication.

Beyond the clinic walls, a parallel ecosystem of unregulated “concierge” intermediaries has emerged, promising convenience, donor matching, remote coordination, and personalized protocols. When such companies fail—some have abruptly closed—patients can be left with canceled procedures, stranded funds, and fragmented records. Critically, because these businesses do not perform licensed IVF activities themselves, they may fall outside the fertility regulator’s remit, leaving consumers with fewer protections.

In contrast, HFEA‑licensed clinics have formal obligations to protect patients’ interests and stored gametes or embryos in the event of closure. They must provide information, ensure safe custody and transfer of biological materials, and support continuity of care. That safety net often does not extend to virtual middlemen, who may hold your money and data while contracting with clinics you never directly pay or authorize. If the intermediary collapses, downstream providers might not have access to your records or funds, even when you’ve already paid.

Practical consumer protection starts before you sign. Verify that the treating facility is HFEA‑licensed; scrutinize who holds your funds and under what terms; avoid large upfront packages without robust escrow or refund protections; and obtain explicit contingency plans for business continuity, data access, and clinical handover. Digital and remote models can enhance access, but the legal framework needs to catch up so that innovation does not come at the expense of basic patient safeguards.

Finally, remember that upsells thrive in uncertainty. Vendors may emphasize relative risk lifts or secondary outcomes while downplaying absolute live‑birth gains, side effects, cycle delays, and trade‑offs. Your best defense is insisting on absolute numbers for patients like you, clear statements about trial quality and endpoints, and a plan for what changes if the add‑on yields no measurable benefit.

Anchor every decision to live‑birth evidence in people like you. Ask whether there is at least one high‑quality randomized trial showing a live‑birth benefit for your age, diagnosis, and treatment type. If the answer leans on meta‑analyses pooling small and heterogeneous studies, ask how consistent the effect is across trials and whether timing, protocol, or patient selection explains differences.

Request your absolute probability of live birth with and without the add‑on, not just relative gains. A relative increase can sound impressive while translating into a clinically trivial change in absolute terms if baseline probabilities are low. Insist on numbers expressed per embryo transfer or per started cycle as appropriate, and clarify whether estimates apply to fresh or frozen transfers.

Probe the safety and burden honestly. What are the risks, discomforts, and potential cycle delays? How often do additional visits or procedures occur? Will this add‑on replace, duplicate, or postpone a proven step? And if the evidence hinges on precise timing (as with some implantation‑focused strategies), who is coordinating that timing and what happens if the window is missed?

Finally, treat financial transparency as a clinical quality metric. Get the total cost and itemization in writing, including cancellation and closure policies, who holds the funds, and how refunds are processed. Confirm licensure for the treating clinic, and if any entity involved is unlicensed, document what statutory protections do—and do not—apply to your case.

Give a green light to add‑ons only when there is clear, reproducible randomized evidence of increased live births in patients like you and when major guidelines agree. These are the circumstances where an add‑on likely merits its cost and burden because the endpoint that matters—bringing home a baby—moves in a meaningful way.

Use a yellow light for situations where pooled analyses suggest possible benefit but with heterogeneity, timing sensitivities, or lack of validated subgroups. Proceed only with fully informed consent, realistic expectations, and a pre‑defined stopping rule if there is no early signal of benefit. Be explicit about what constitutes “success” and how soon you will reassess.

Keep a red light for add‑ons that guidelines advise against or for which high‑quality evidence is lacking in your situation. Avoid paying more for procedures that are invasive, time‑consuming, or that siphon funds from steps with proven effectiveness. If you are deeply interested in an experimental approach, explore participation in a properly approved clinical trial where monitoring, transparency, and learning are built into the design.

Above all, separate marketing logic from medical logic. The fact that a technology is new, personalized, or data‑rich does not guarantee a higher chance of live birth. The burden of proof sits with those selling the add‑on. Your role is to demand numbers that matter, protections that endure, and a care plan that prioritizes outcomes over optics.