Recombinant follicle‐stimulating hormone (follitropin alfa) for ovulation induction in Japanese patients with anti‐estrogen‐ineffective oligo‐ or anovulatory infertility: results of a phase II dose–response study

Taketani, Yuji; Kelly, Eduardo; Yoshimura, Yasunori; Hoshiai, Hiroshi; Irahara, Minoru; Mizunuma, Hideki; Saito, Hidekazu; Andoh, Kazumichi; Bebia, Zourab; Yanaihara, Takumi

doi:10.1007/s12522-009-0044-7

Cited by 6 publications

(2 citation statements)

References 20 publications

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“…The results confirmed that maintaining the same FSH starting dose for 14 days before increasing it in a step-up regimen is critical to control the risk of over-response [20]. A randomized, double-blind, dose-finding study aiming to determine the optimal regimen of r-hFSH for OI in Japanese women with amenorrhea or anovulatory infertility concluded that a starting dose of 75 IU of r-hFSH (compared to a starting dose of 37.5 IU and 150 IU) is associated with favorable results and safety profile [21].…”

Section: Global Journal Of Reproductive Medicinementioning

confidence: 99%

Strategies to Improve Outcomes of Ovulation Induction and Assisted Reproductive Technology (ART): The Iraqi Consensus

Mohammadzadeh,

Al-Izzi,

Al-Obaidi

et al. 2023

GJORM

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The ESHRE 2019 Guidelines provide clinicians with valuable evidence-based recommendations to optimize ovarian induction and ovarian stimulation in in vitro fertilization (IVF). However, data from such guidelines are primarily based on randomized controlled trials with highly selected populations that are conducted under very controlled conditions. To complement evidence from clinical guidelines and further improve treatment outcomes, seven Iraqi experts gathered to evaluate opinions on the specific approaches during an IVF cycle in Iraq and developed 15 statements agreed upon: The Iraqi Consensus. A Delphi consensus was conducted to formulate expert opinion on how assisted reproductive technology outcomes could be improved. Step 1 involved the scientific Board, comprising the scientific coordinator, who developed the initial statements and supporting references, which were discussed/amended by seven experts, and refined the final statements and references. Step 2 involved 30 Iraqi experts voted on their level of agreement/disagreement with each statement. Consensus was reached if the proportion of participants agreeing/disagreeing with a statement was >66%. Step 3 data was collected and analyzed then communicated to participating experts. Consensus was achieved for 15 statements with high level of agreement in >85% of statements, tackling follicular development/gonadotropins; pituitary suppression; final oocyte maturation triggering; luteal-phase support. This represents the collective point of view of the experts that took part in the consensus development and are based on local practice. This Delphi consensus provides a real-world clinical perspective from Iraqi experts and complements the international guidelines, and may help to further improve treatment outcomes in Iraq and the region.

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Section: Global Journal Of Reproductive Medicinementioning

confidence: 99%

Strategies to Improve Outcomes of Ovulation Induction and Assisted Reproductive Technology (ART): The Iraqi Consensus

Mohammadzadeh,

Al-Izzi,

Al-Obaidi

et al. 2023

GJORM

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“…An earlier Phase II dose-finding study using a low-dose step-up protocol for OI showed that a starting dose of 75 IU r-hFSH (follitropin alfa), with 37.5 IU increments, was associated with a favorable efficacy and safety profile in Japanese women with amenorrhea I or anovulatory infertility [10]. In this Phase III study, the efficacy and safety of follitropin alfa were compared with those of purified urinederived FSH (urofollitropin), using a low-dose step-up protocol for follicle development and OI in Japanese women with anovulatory infertility who were menstruating or had progestin-positive amenorrhea, including PCOS.…”

Section: Introductionmentioning

confidence: 99%

Recombinant follicle‐stimulating hormone (follitropin alfa) versus purified urinary follicle‐stimulating hormone in a low‐dose step‐up regimen to induce ovulation in Japanese women with anti‐estrogen‐ineffective oligo‐ or anovulatory infertility: results of a single‐blind Phase III study

Taketani

Kelly

Yoshimura

et al. 2010

Reprod Medicine & Biology

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Purpose We aimed to compare the efficacy and safety of recombinant human follicle-stimulating hormone (follitropin alfa) and purified urinary human follicle-stimulating hormone (urofollitropin) for ovulation induction in Japanese women with anovulatory infertility;also to verify the noninferiority (in terms of ovulation rate) of follitropin alfa versus urofollitropin. Methods In a Phase III, multicenter, single-blind, parallel-group study, we enrolled 265 Japanese women aged 20-39 years. The patients were menstruating without apparent ovulation or were amenorrheic (with a positive progestin challenge test), and had failed to conceive with anti-estrogen ovulation-induction therapy. The patients underwent a low-dose step-up regimen using follitropin alfa or urofollitropin with a starting dose of 75 IU. The primary endpoint was the proportion of patients who ovulated (mid-luteal serum progesterone C5 ng/mL and/or confirmed clinical pregnancy). Secondary endpoints included the proportion of patients with a dominant follicle (C18 mm) and the duration of stimulation. Results Ovulation occurred in 79.1% and 82.6% of the patients who received follitropin alfa and urofollitropin, respectively, in the full-analysis set (n = 261), and in 79.2% and 82.5% of the per-protocol set (n = 251). The predefined noninferiority criteria for the primary endpoint were achieved. No significant differences were observed in 123Reprod Med Biol (2010) 9:99-106 DOI 10.1007 any secondary endpoint. Treatment-emergent adverse events were reported by a similar proportion of patients in each group (follitropin alfa, 53.5%; urofollitropin, 50.0%). Conclusions No significant difference in the primary efficacy endpoint (rate of ovulation) was observed between follitropin alfa and purified urofollitropin in women with anovulatory infertility who were menstruating or had progestin-positive amenorrhea. The use of treatment holidays in this study prevents comparison of the data with previous trials that utilized consecutive daily doses.

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Recombinant FSH versus urinary gonadotrophins or recombinant FSH for ovulation induction in subfertility associated with polycystic ovary syndrome

Nahuis

Bayram

Veen

et al. 2015

Cochrane Database of Systematic Reviews

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Recombinant follicle‐stimulating hormone (follitropin alfa) for ovulation induction in Japanese patients with anti‐estrogen‐ineffective oligo‐ or anovulatory infertility: results of a phase II dose–response study

Abstract: A starting dose of 75 IU r-hFSH was associated with a favorable efficacy and safety profile for OI in Japanese women.

Cited by 6 publications

References 20 publications

Strategies to Improve Outcomes of Ovulation Induction and Assisted Reproductive Technology (ART): The Iraqi Consensus

Strategies to Improve Outcomes of Ovulation Induction and Assisted Reproductive Technology (ART): The Iraqi Consensus

Recombinant FSH versus urinary gonadotrophins or recombinant FSH for ovulation induction in subfertility associated with polycystic ovary syndrome

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