Repeated in vitro fertilization cycle attempts in patients undergoing controlled ovarian hyperstimulation with use of gonadotropin-releasing hormone antagonists

Rabinson, Jacob; Ashkenazi, Jacob; Homburg, Roy; Meltcer, Simion; Anteby, Eyal Y.; Orvieto, Raoul

doi:10.1016/j.fertnstert.2008.07.1725

Cited by 10 publications

(6 citation statements)

References 9 publications

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“…Total dose of r-hFSH (Ovaleap® or Gonal-f®) increased from the first treatment cycle in the Main study to the second and third Ovaleap® cycles in the current study. This is consistent with previous studies showing increased gonadotropin dose in patients receiving multiple IVF treatment cycles [ 23 , 24 ] and can be understood as being due to the poorer response of these patients to FSH stimulation, as indicated by not achieving pregnancy following the first IVF cycle. However, the median total dose of Ovaleap® in the current study was consistent with the Gonal-f® dose used in other clinical trials for optimal follicular development [ 15 , 17 – 19 ].…”

Section: Discussionsupporting

confidence: 92%

Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study

Strowitzki

Kuczyński

Mueller

et al. 2016

Reprod Biol Endocrinol

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BackgroundOvaleap® (follitropin alfa), a recombinant human follicle-stimulating hormone intended for use in controlled ovarian stimulation in women undergoing assisted reproductive technologies (ART), showed therapeutic equivalence to Gonal-f® in a multinational, multicenter, randomized, controlled, assessor-blind phase 3 Main Study. The current study examined safety, including immunogenicity, and efficacy of Ovaleap® in an open-label, uncontrolled, follow-up treatment period of up to 2 additional treatment cycles in patients who did not become pregnant in the phase 3 Main Study.MethodsPatients with negative biochemical or clinical pregnancy in the phase 3 Main Study, regardless of treatment group (ie, Ovaleap® or Gonal-f®), were eligible to participate. Patients received Ovaleap® (Merckle Biotec GmbH, Ulm, Germany) for up to 2 additional cycles, administered using a reusable semi-automated pen device. The primary objective was the assessment of safety, including adverse events (AEs), ovarian hyperstimulation syndrome (OHSS), and anti-drug antibodies. Tolerability, patient satisfaction with the Ovaleap® pen device, and efficacy outcomes (as evaluated in the Main Study) were also assessed.ResultsOne hundred forty-seven patients were included in cycle 2, and 61 patients were included in cycle 3. In cycles 2 and 3, 10.9 % (16/147) and 6.6 % (4/61) of patients experienced treatment-emergent AEs (TEAEs), respectively. Three serious TEAEs (ie, appendicitis, OHSS, and borderline ovarian tumor) were reported and successfully resolved. The OHSS TEAE was the only OHSS reported in the study (0.7 % [1/147]). Positive findings on anti-drug antibody assays in 6 serum samples did not show neutralizing activity or clinical relevance in biochemical pregnancy rate. No hypersensitivity reaction occurred. Most patients reported “very good”/“good” local tolerability. All patients were “very confident”/“confident” about dose accuracy and correctness of the injection. They all found use of the pen “very convenient”/“convenient” and were all “very satisfied”/“satisfied” with the pen device. Efficacy outcomes were consistent with the phase 3 Main Study.ConclusionsThese findings further support the safety, including immunogenicity, and efficacy of Ovaleap® for stimulation of follicular development in infertile women undergoing ART. The findings support continued use of Ovaleap® for multiple cycles or a switch to Ovaleap® if pregnancy is initially not achieved with Gonal-f®.Trial registrationEudraCT number: 2009-017674-20. Current controlled trials register number: ISRCTN74772901.

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Section: Discussionsupporting

confidence: 92%

Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study

Strowitzki

Kuczyński

Mueller

et al. 2016

Reprod Biol Endocrinol

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“…Only a small fraction of women received a reduced dose. As a consequence, and in line with previous reports from repeated stimulation cycles (Eppsteiner et al, 2014;Rabinson et al, 2009;Strowitzki et al, 2016), the mean total dose increased for each cycle in both treatment groups. Comparing the total FSH dose, it is noteworthy that while the follitropin delta dose was fixed throughout stimulation, dose increments during stimulation were applied quite extensively in the follitropin alfa group in all cycles.…”

Section: Figuresupporting

confidence: 91%

“…women with a better prognosis. Reduced pregnancy rates in repeated stimulation cycles have been described previously (Rabinson et al, 2009;Rettenbacher et al, 2015;Strowitzki et al, 2016), but sustained pregnancy rates during repeated stimulation were also reported (Norman et al, 2011).…”

Section: Figurementioning

confidence: 81%

Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial

Bosch

Havelock

Martín³

et al. 2019

Reproductive BioMedicine Online

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6, † , for the ESTHER-2 Study Group KEY MESSAGEFollitropin delta can be safely used for repeated ovarian stimulation, shown by its low immunogenicity potential and sustained safety in an expanded dose range. The trial also confirms the appropriateness of the follitropin delta dosing regimen in repeated cycles, with documented efficacy in terms of ovarian response, pregnancy and live birth rates.

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“…In one center, pregnancy rates were equivalent in cycles 1 and 2, 3 and 4, and 5 through 8. 363 At some centers, repeated IVF cycles after cycle 3 are associated with lower per-cycle pregnancy rates. 364 A large study of 14,265 women of various ages from the SART database of Massachusetts residents who underwent up to four ART cycles demonstrated that the cumulative pregnancy rate per woman increased for all five age groups (Fig.…”

Section: Repeat In Vitro Fertilization Cyclesmentioning

confidence: 99%

Assisted Reproduction

Ginsburg¹,

Racowsky²

2014

Yen &Amp; Jaffe's Reproductive Endocrinology

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Repeated in vitro fertilization cycle attempts in patients undergoing controlled ovarian hyperstimulation with use of gonadotropin-releasing hormone antagonists

Cited by 10 publications

References 9 publications

Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study

Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study

Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial

Assisted Reproduction

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