Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database

Mahony, M.C.; Hayward, Brooke; Mottla, Gilbert L.; Richter, K.S.; Beall, Stephanie; Ball, G.D.; D’Hooghe, Thomas

doi:10.3389/fendo.2021.742089

Cited by 5 publications

(3 citation statements)

References 52 publications

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“…A potential limitation of the study is that adjustments in rhFSH dose were permitted during COS (38), with adjustments limited to 50 IU. The dose adjustment of rhFSH is part of daily clinical practice during COS, and a systematic review covering 10 years showed that the proportion was about 45% (39).…”

Section: Pregnancy and Birth Outcomesmentioning

confidence: 99%

Comparison of two different starting dose of rhFSH in GnRH antagonist protocol for patients with normal ovarian reserve

Jia

Li²,

Li³

et al. 2023

Front. Endocrinol.

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ObjectiveTo evaluate different starting doses of recombinant human follicle-stimulating hormone (rhFSH) on pregnancy outcomes for patients with normal ovarian reserve during gonadotropin- releasing hormone antagonist (GnRH-ant) protocol-controlled ovarian stimulation of in vitro fertilization (IVF) cycles.MethodsIn this retrospective study, a total of 1138 patients undergoing IVF cycles following the GnRH-ant protocol were enrolled. Patients were divided into two groups according to the starting dose of rhFSH. 617 patients received a starting dose of rhFSH of 150 IU, and 521 patients received a starting dose of rhFSH of 225 IU. We compared demographic characteristics, ovarian stimulation and embryological characteristics, and pregnancy and birth outcomes between the two groups. Multivariate logistic regression analysis was performed to examine the possible effects of the known potential confounding factors on pregnancy outcomes.ResultsThe number of oocytes retrieved in the 150 IU rhFSH group was significantly lower than those in the 225 IU rhFSH group. There was no significant difference between the two groups referring to embryological characteristics. The proportion of fresh embryo transfer in the 150 IU rhFSH group was significantly higher than that in the 225 IU rhFSH group (48.30% vs. 40.90%), and there was no difference in the risk of ovarian hyperstimulation syndrome and pregnancy outcomes between the two groups.ConclusionsIn conclusion, the starting dose of rhFSH of 150 IU for ovarian stimulation has a similar pregnancy outcome as starting dose of rhFSH of 225 IU in GnRH-ant protocol for patients with normal ovarian reserve. Considering the potential cost-effectiveness and shorter time to live birth, the starting dose of rhFSH of 150 IU may be more suitable than 225 IU.

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Section: Pregnancy and Birth Outcomesmentioning

confidence: 99%

Comparison of two different starting dose of rhFSH in GnRH antagonist protocol for patients with normal ovarian reserve

Jia

Li²,

Li³

et al. 2023

Front. Endocrinol.

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“…Dosing may then be adjusted during the cycle or in subsequent cycles depending on patient response. The approach of individualizing gonadotropin doses in OS for IVF is common in clinical practice across the US and occurs more often in younger versus older patients ( 17 ), and has demonstrated comparable efficacy and increased safety compared with conventional fixed dosing ( 14 ). However, there is a lack of corresponding data on gonadotropin dose adjustments in OI/OS for timed intercourse or IUI.…”

Section: Introductionmentioning

confidence: 99%

“…Optimization of gonadotropin starting doses and dose adjustments occurred in 40.7% of cycles during OS for assisted reproductive technology, according to one report of real-world data ( 17 ), and in up to 45% of patients during OS for IVF, according to a recent systematic review of clinical studies ( 1 ). However, the prevalence and magnitude of dose adjustments in OI/OS for timed intercourse or IUI, and the clinical characteristics and demographics of patients undergoing OI/OS for timed intercourse or IUI with gonadotropins receiving dose adjustments have not, to the best of our knowledge, been assessed in real-world databases.…”

Section: Introductionmentioning

confidence: 99%

Fine-tuning the dose of recombinant human follicle-stimulating hormone alfa to individualize treatment in ovulation induction and ovarian stimulation cycles: a real-world database analysis

Martini,

Beall,

Ball

et al. 2023

Front. Endocrinol.

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IntroductionFine-tuning of injectable gonadotropin doses during ovulation induction (OI) or ovarian stimulation (OS) treatment cycles with the aim of using doses low enough to minimize the risk of excessive ovarian response while maintaining optimal efficacy may be facilitated by using an adjustable-dose pen injector. We examined the incidence and magnitude of individualized gonadotropin dose adjustments made during cycles of OI or OS, followed by either timed intercourse or intrauterine insemination, with or without oral medications, and assessed the relationship between patient characteristics and dosing changes using real-world evidence.MethodsThis was an observational, retrospective cohort study using electronic medical records from a large US database of fertility centers. Data from patients who had undergone a first recombinant human follicle stimulating hormone alfa (r-hFSH-alfa/follitropin alfa) treated OI/OS cycle followed by timed intercourse or intrauterine insemination between 2015 and 2016 were included. Percentages of OI/OS cycles involving r-hFSH-alfa dose adjustments (in increments of ±12.5 IU or greater) with or without oral medications (clomiphene citrate or letrozole) were analyzed.ResultsOf 2,832 OI/OS cycles involving r-hFSH-alfa administration, 74.6% included combination treatment with orals; 25.4% involved r-hFSH-alfa alone. As expected, the starting dose of r-hFSH-alfa was lower for cycles that used r-hFSH-alfa with orals than r-hFSH-alfa only cycles (mean [SD]: 74.2 [39.31] vs 139.3 [115.10] IU). Dose changes occurred in 13.7% of r-hFSH-alfa with orals versus 43.9% of r-hFSH-alfa only cycles. Dose adjustment magnitudes ranged from ±12.5 IU to ±450 IU. The smallest adjustment magnitudes (±12.5 IU and ±25 IU) were used frequently and more often for dose increases than for dose decreases. For r-hFSH-alfa with orals and r-hFSH-alfa only cycles, the smallest adjustments were used in 53.5% and 64.5% of cycles with dose increases and in 35.7% and 46.8% of cycles with dose decreases, respectively.DiscussionIn OI/OS cycles followed by timed intercourse or intrauterine insemination, r-hFSH-alfa dose adjustments were frequent. In cycles that included orals, r-hFSH-alfa starting doses were lower and dose changes were fewer than with r-hFSH-alfa alone. Smaller dose adjustments facilitate individualized treatment with the goal of reducing the risks of multiple gestation, cycle cancellation, and ovarian hyperstimulation syndrome.

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The HERA (Hyper-response Risk Assessment) Delphi consensus for the management of hyper-responders in in vitro fertilization

Feferkorn,

Santos-Ribeiro,

Ubaldi

et al. 2023

J Assist Reprod Genet

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Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database

Cited by 5 publications

References 52 publications

Comparison of two different starting dose of rhFSH in GnRH antagonist protocol for patients with normal ovarian reserve

Comparison of two different starting dose of rhFSH in GnRH antagonist protocol for patients with normal ovarian reserve

Fine-tuning the dose of recombinant human follicle-stimulating hormone alfa to individualize treatment in ovulation induction and ovarian stimulation cycles: a real-world database analysis

The HERA (Hyper-response Risk Assessment) Delphi consensus for the management of hyper-responders in in vitro fertilization

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