Evidence memo / Reproductive & endocrine

Lutropin alfa

Also: Luveris · recombinant LH · recombinant luteinizing hormone · r-hLH

Lutropin alfa (Luveris) is lab-made luteinizing hormone (LH), used together with FSH to help eggs mature in women who make very little LH of their own. It is the pure-LH piece of the fertility-hormone set. It was FDA-approved in 2004 but later withdrawn from the US market for commercial reasons, while remaining available elsewhere. The Watchlist boundary is keeping it to that narrow LH-supplementation role, distinct from FSH (follitropin) and from the FSH-plus-LH urinary product (menotropins).

Approved for specific usesApproved specific use

The verdict

Our read at a glance.

Whether lutropin alfa is understood as supplemental LH for the specific group of women with very low LH who are undergoing fertility treatment with FSH, rather than a general fertility or hormone booster.

The signal
Trials show that adding recombinant LH to FSH improves follicle development and outcomes specifically in women with profound LH deficiency; in women with normal LH, the added benefit of routine LH supplementation is much less clear.
The unknown
Exactly which patients beyond the profoundly LH-deficient gain from added LH, and how recombinant LH compares with the LH activity already present in urinary gonadotropins (menotropins) or hCG.
Our read
A narrow, logical fertility tool: pure recombinant LH to fill in for women who make almost none, used alongside FSH. Its benefit is clearest in genuine LH deficiency, not as a routine add-on for everyone, and it is a specialist product (FDA-approved but later pulled from the US market), distinct from FSH and from the mixed urinary gonadotropins.

The mechanism

How it works.

Maturing an egg-containing follicle takes a partnership of two pituitary hormones: FSH grows the follicle, and LH supports the cells that make estrogen and help the egg finish maturing. Most women undergoing fertility stimulation have enough of their own LH, so they mainly need extra FSH. But a small group makes almost no LH (for example, in certain pituitary or hypothalamic conditions), and FSH alone is not enough. Lutropin alfa is recombinant LH, made in cells and purified, given by injection alongside FSH to supply the missing LH so follicles can develop properly. It is the single-hormone (LH-only) counterpart to follitropin (FSH-only), whereas menotropins supplies both at once.

Safety & regulatory boundary

The consequential part.

Used with FSH for ovarian stimulation, it shares the gonadotropin risks of ovarian hyperstimulation and multiple pregnancy, so treatment is monitored. It was FDA-approved (as Luveris) but later discontinued in the US market for commercial reasons; it remains available in some other countries. It is a specialist fertility medicine for LH-deficient women, not a general fertility, hormone, or performance treatment, and it is distinct from FSH (follitropin) and from urinary FSH-plus-LH (menotropins).

What's next

What we're watching.

Clearer definition of who benefits from added LH, and how recombinant LH compares with urinary gonadotropins and with combined FSH/LH products.

Context

Why this is discussed.

Growing mature eggs needs two hormones, FSH and LH. Most fertility stimulation relies mainly on FSH, but a small group of women make almost no LH and need it supplied too. Lutropin alfa is recombinant LH for exactly that situation, the pure-LH counterpart to the FSH drug follitropin.

The evidence base

10 cited references.

Keep reading

Related published memos.