Highly purified FSH is as efficacious as recombinant FSH for ovulation induction in women with WHO Group II anovulatory infertility: a randomized controlled non-inferiority trial

Balen, Adam; Platteau, Peter; Andersen, Anders Nyboe; Devroey, Paul; Helmgaard, L.; Arce, Joan‐Carles

doi:10.1093/humrep/dem075

Cited by 38 publications

(55 citation statements)

References 24 publications

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“…The biosimilarity between Bemfola (Finox AG, Switzerland) and Gonal-f (Merck Serono, Germany) for various efficacy parameters was coupled with a safety profile that is consistent with other studies in this clinical setting (Recombinant Human FSH Study Group, 1995;Bergh et al, 1997;Frydman et al, 2000;Schats et al, 2000;Balen et al, 2007). In addition, Bemfola (Finox AG, Switzerland) treatment did not result in increased immunogenicity compared with the reference comparator Gonal-f (Merck Serono, Germany).…”

Section: P-valuesupporting

confidence: 73%

A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

Rettenbacher¹,

Andersen

Garcia-Velasco

et al. 2015

Reproductive BioMedicine Online

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Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20-38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre-determined clinical equivalence margin of ±2.9 oocytes. Compared with Gonal-f, Bemfola treatment resulted in a statistically equivalent number of retrieved oocytes (Bemfola 10.8 ± 5.11 versus Gonal-f 10.6 ± 6.06, mean difference: 0.27 oocytes, 95% confidence interval: -1.34, 1.32) as well as a similar clinical pregnancy rate per embryo transfer in first and second cycles (Bemfola: 40.2% and 38.5%, respectively; Gonal-f: 48.2% and 27.8%, respectively). No difference in severe ovarian hyperstimulation syndrome was observed between treatment groups (Bemfola: 0.8%; Gonal-f: 0.8%). This study demonstrates similar clinical efficacy and safety profiles between Bemfola and Gonal-f, and suggests that Bemfola can be an appropriate alternative in ovarian stimulation protocols.

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Section: P-valuesupporting

confidence: 73%

A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

Rettenbacher¹,

Andersen

Garcia-Velasco

et al. 2015

Reproductive BioMedicine Online

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“…The ovulation rate was 85.2% with HP-FSH and 90.9% with rFSH. No differences were noted between groups in number of follicles ≥12mm, ≥15mm or ≥18mm, mono-follicular development, pregnancy rates, endometrial thickness, number of ovarian stimulation syndrome cases (25). …”

Section: Discussionmentioning

confidence: 88%

110 Comparison of Highly Purified Urinary Versus Recombinant Fsh: Effect on Art Outcomes in Polycystic Ovary Syndrome

Sohrabvand¹,

Sheikhhassani²,

Bagheri³

et al. 2010

Reproductive BioMedicine Online

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Background: Polycystic ovary syndrome (PCOS) is a common cause of ovulatory disorders and infertility with high LH to FSH ratio. In order to prevent further increase of LH and follicle atresia, different regimens for ovulation induction have been recommended using FSH alone. Objective: This study was performed in PCOS patients to compare ART outcomes in cycles induced by FSH alone, using either recombinant or urinary products. Materials and Methods:In a randomized trial, from 623 patients who underwent down regulation with GnRH analogue in a long protocol, 160 PCOS patients were randomly divided into two groups of 80. Group A received 150 IU/d recombinant FSH (Gonal-F) and group B 150 IU/d urinary FSH (Fostimon). Results: 33 cases (41.2%) in group A and 36 (45%) in group B achieved clinical pregnancy, which was not significantly different (p=0.67). Total number of oocytes retrieved (13.03±5.56 vs. 14.17±4.89, p=0.17), quality and number of embryos (7.42±3.35 vs. 7.63±3.28, p=0.68) and OHSS rate were similar in group A compared to group B. Endometrial thickness which was 9.66±1.67 mm in group A and 10.36±1.35 mm in group B, showed a significant difference (p=0.004). Conclusion: It seems that in PCOS patients, both pure FSH products used for controlled ovarian hyperstimulation have similar effects on ART outcome and can be used according to availability and patient acceptance without significant difference.

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“…In a recent Cochrane review of four randomized trials comparing rFSH versus urinary FSH for ovulation induction for women with polycystic ovarian syndrome, it was concluded that there was not enough evidence to recommend one of these products over the other (4). In addition, a recent randomized trial of HP-hFSH versus rFSH found that HP-hFSH was noninferior compared with rFSH with respect to ovulation rate in anovulatory World Health Organization Group II of women who failed to ovulate or conceive on clomiphene citrate (5). Although a recent randomized study of rFSH and urinary products suggested a better outcome with rFSH in intrauterine insemination cycles for unexplained infertility, the urinary comparators used were older products no longer used in the United States (6).…”

Section: Discussionmentioning

confidence: 99%

Clinical efficacy of highly purified urinary FSH versus recombinant FSH in volunteers undergoing controlled ovarian stimulation for in vitro fertilization: a randomized, multicenter, investigator-blind trial

Baker

Fujimoto

Kettel

et al. 2009

Fertility and Sterility

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Highly purified FSH is as efficacious as recombinant FSH for ovulation induction in women with WHO Group II anovulatory infertility: a randomized controlled non-inferiority trial

Abstract: This urinary HP-FSH preparation is non-inferior compared with a rFSH preparation with respect to ovulation rate in anovulatory WHO Group II women failing to ovulate or conceive on clomiphene citrate.

Cited by 38 publications

References 24 publications

A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

110 Comparison of Highly Purified Urinary Versus Recombinant Fsh: Effect on Art Outcomes in Polycystic Ovary Syndrome

Clinical efficacy of highly purified urinary FSH versus recombinant FSH in volunteers undergoing controlled ovarian stimulation for in vitro fertilization: a randomized, multicenter, investigator-blind trial

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