Hormone medicines
Follitropin beta
A recombinant FSH medicine with selected infertility indications; historical pregnancy comparisons need their original population and comparator.
Pooled analysis of three randomized IVF trials; current product-specific label; checked 2026-10-01
Also known as: Follistim AQ · Puregon
Practical use
Clinical purpose, evidence and review questions
- Keep the product name
- Record the exact formulation and delivery device when discussing treatment history.
- Read the comparison
- Check which gonadotropin, population and reproductive technique were studied.
- Bring response records
- Discuss previous follicle response or semen results, allergy history and the outcome the team is targeting.
Overview
Follitropin beta activates FSH receptors. US Follistim AQ labeling covers selected ovulation-induction, IVF/ICSI and male hypogonadotropic-hypogonadism fertility settings. It is a specific biological product, not a general testosterone-restoration medicine or a substitute for diagnosing infertility.
Risks and limitations
Ovarian treatment can involve hyperstimulation, torsion, multiple pregnancy and vascular complications. Severe abdominal pain, marked swelling or breathing difficulty needs prompt assessment. Product-specific allergy concerns include residual neomycin or streptomycin sensitivity, alongside reproductive-tumor and endocrine contraindications.
How to read this
Recombinant describes production, not automatic clinical superiority. Comparisons can change with the urinary preparation, patient population and reproductive technology used.
Research explained
Historical pooled IVF comparison
Who was studied
A 1997 combined analysis of three prospective multicenter randomized trials: 697 women received follitropin beta and 463 urinary gonadotropins during an IVF cycle.
What was found
Center-weighted ongoing pregnancy at least 12 weeks after embryo transfer was 22.9% versus 17.9%, an absolute difference of 5.0 percentage points (95% CI 0.2–9.7). The analysis also reported an advantage when frozen-embryo cycles were included.
What it cannot establish
This was a pooled analysis with mixed urinary comparators, not a single modern head-to-head trial against every FSH product. Ongoing pregnancy is not identical to live birth.
Read the original studyDo not combine the denominators
A per-started-cycle pregnancy rate and a result including later frozen-embryo transfers answer different questions.
Supporting sourceThe male indication depends on the cause
The label concerns insufficient gonadotropin signaling when infertility is not due to primary testicular failure. Semen assessment and the underlying diagnosis remain central.
Supporting sourceClaims versus findings
Not established
The historical advantage proves superiority over all other FSH products.
The pooled study used particular urinary comparators and older IVF practice; it cannot rank every current option.
Check the evidenceCommon questions
Were these 1,160 participants from one trial?
No. The paper combined three randomized trials, which is an important part of its design.
SourceSources
Historical pooled IVF comparison
US prescribing information; checked October 1, 2026
Sources checked 2026-10-01.
General education; not a personal treatment plan.