Is there a recommended maximum starting dose of FSH in IVF?

Rombauts, Luk

doi:10.1007/s10815-007-9134-9

Cited by 34 publications

(19 citation statements)

References 29 publications

(28 reference statements)

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“…Our observations are consistent with those made in other studies, which suggest that the likelihood of pregnancy reaches a plateau after retrieval of approximately 15 oocytes, but the risk of OHSS increases significantly with ovarian responses above this threshold . Other observational studies have also demonstrated that increasing doses of gonadotropin are associated with reduced rates of pregnancy or live birth, and have inferred that high FSH doses may have a direct effect on oocytes or an indirect effect via a rise in follicular‐phase progesterone on endometrial receptivity …”

Section: Discussionsupporting

confidence: 92%

Is it possible to apply trial outcomes to a real‐world population? A novel approach to External Validity Analysis

Agresta

Fois²,

Garrett

et al. 2019

Aust NZ J Obst Gynaeco

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Background Translation of findings from randomised controlled trials (RCT), the foundation of evidence‐based medicine, into clinical practice requires an understanding of relationships between patient characteristics, treatment practices and outcomes. We propose a novel technique, External Validity Analysis (EVA), to evaluate applicability of findings from a large RCT, comparing baseline characteristics, interventions and outcomes between the RCT and a large clinical database. Aim To perform EVA of the findings of a randomised controlled trial (ESTHER‐1) to a population in an Australian clinic setting. To demonstrate this method, we evaluated the discordance in first cycle follicle‐stimulating hormone (FSH) exposure and outcomes between the two populations, to inform clinical practice. Materials and Methods In this retrospective, descriptive analysis, we compared practices and outcomes between the follitropin alfa ‘conventional’ dosing arm of the ESTHER‐1 trial and a selected comparable clinic subpopulation of patients who underwent controlled ovarian stimulation using FSH. Results Mean FSH exposure was 34% higher in the clinic subpopulation than in the trial subpopulation, resulting in higher average ovarian response without improving the likelihood of clinical pregnancy or live birth. Conclusions EVA allowed for the comparison of a trial population with a selected clinic population with similar characteristics. With respect to FSH consumption, this analysis revealed higher exposure to FSH in the clinic setting without a corresponding benefit. The comparison reveals population differences as well as the potential to improve clinical outcomes through a reappraisal of current practices and objectives in gonadotropin dose selection.

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Section: Discussionsupporting

confidence: 92%

Is it possible to apply trial outcomes to a real‐world population? A novel approach to External Validity Analysis

Agresta

Fois²,

Garrett

et al. 2019

Aust NZ J Obst Gynaeco

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“…The data from the Trust trial analyzed in this study also successfully illustrate the regression to the mean effect in patients with an extreme response (i.e., low response or high response) (10). In the Trust study, 45.8% of low/high responders in cycle 1 went on to have a normal response in cycle 2 without changes in the stimulation protocol (Supplemental Table 8).…”

Section: Discussionmentioning

confidence: 71%

Intercycle variability of the ovarian response in patients undergoing repeated stimulation with corifollitropin alfa in a gonadotropin-releasing hormone antagonist protocol

Rombauts

Lambalk

Schultze-Mosgau

et al. 2015

Fertility and Sterility

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“…Статистические данные обсчета вторичных точек исследования: применение сравниваемых препаратов Примапур ® и Гонал-ф ® статистически не отличается по количеству проведенных переносов на 3-й и 5-й день развития эмбрионов. женщин с нормальным овариальным резервом, в циклах с антагонистами ГнРГ и стартовой дозой ФСГ, равной 150 МЕ [16][17][18][19][20][21][22].…”

Section: результаты и обсуждениеunclassified

Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®)

Barakhoeva¹,

Vovk

Zorina³

et al. 2018

Akušerstvo, ginekologiâ i reprodukciâ

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A clinical study on the efficacy and safety of follitropin alfa has been conducted. The aim of the study was to confirm the therapeutic equivalence between the follitropin alfa biosimilar (Primapur®) and the reference medication (Gonal-f®) in controlled induction of superovulation within the assisted reproductive technologies (ART) programs. Materials and methods. This multicenter, randomized, blind at the embryological stage, in parallel groups, comparative study of phase III (RCT 754 from 26.10.16/NCT03088137) involved 110 women aged 20-35 years with established causes of infertility (tubal factor, male factor). The patients were randomized into 2 equal groups of 55 participants each. The primary end-point for assessing the therapeutic equivalence was the number of aspirated oocytes. The secondary end-points included the number of fertilized oocytes, the number of days of stimulation, the total dose of the injected drug, the occurrence rate of biochemical and clinical pregnancies. Results. In this study, the follitropin alfa biosimilar was shown to be equivalent to the original follitropin in terms of the number of aspirated oocytes. Also, no statistically significant differences were found in the number of mature and fertilized oocytes, the days of stimulation, the dose of the drug administered during the treatment, and the rate of the onset of biochemical or clinical pregnancy. Conclusion. The therapeutic equivalence between the follitropin alfa containing Primapur® and Gonal-f® has been demonstrated.

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Is there a recommended maximum starting dose of FSH in IVF?

Cited by 34 publications

References 29 publications

Is it possible to apply trial outcomes to a real‐world population? A novel approach to External Validity Analysis

Is it possible to apply trial outcomes to a real‐world population? A novel approach to External Validity Analysis

Intercycle variability of the ovarian response in patients undergoing repeated stimulation with corifollitropin alfa in a gonadotropin-releasing hormone antagonist protocol

Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®)

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