Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency

Fauser, Bart C.J.M.; Mannaerts, Bernadette; Devroey, Paul; A, Leader; Boime, Irving; Baird, D. T.

doi:10.1093/humupd/dmn065

Cited by 136 publications

(94 citation statements)

References 89 publications

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“…Herein we also show that the late administration of CFα allows to add GnRH-antagonist from day 8 of the cycle instead than from day 5, as suggested when CFα is given on day 2 to expected normal responders (12,13); this is another issue that further lowers the number of injections. In the present study, the late-start CFα protocol enabled us to complete COS with an average total number of injections of 7.8±3.8 (range [4][5][6][7][8][9][10][11], which is definitely low in comparison with a standard COS, lower than observed after day 2 CFα administration (12,13), and significantly lower than observed in case of daily rFSH administration from day 4 of the cycle. This could possibly increase the patients' satisfaction and compliance to treatment and, on the other side, decrease the economical costs of IVF for medications.…”

Section: Discussionmentioning

confidence: 67%

“…CFα has the ideal kinetic to be applied in late-start protocols, when exogenous gonadotropin administration is started on day 4 of the menstrual cycle. Circulating FSH peak is reached approximately 24 h after CFα is injected subcutaneously, more quickly than after repeated rFSH daily injections, and sustained FSH levels are maintained for 7 days due to the long half-life of the molecule (7,10,11). In practical terms, when CFα is injected on day 4 of the cycle, blood FSH peak is reached on day 5 and steady FSH levels are maintained until day 11, when only some patients would need further FSH administration to complete follicular growth.…”

Section: Discussionmentioning

confidence: 99%

“…The carboxy-terminal peptide addition to FSH maintains the specific binding to FSH receptor and does not confer any LH activity to the molecule (5, 6), but changes its kinetic (7). After a single subcutaneous injection, CFα reaches peak serum levels after approximately 24 h, and having a long circulating half-life, provides a reliable FSH stimulus able to initiate and sustain multiple follicular development for 7 days (7)(8)(9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of late-start Corifollitropin-alfa administration for controlled ovarian hyperstimulation in IVF: a cohort, case–control study

Revelli

Pittatore

Casano

et al. 2015

J Assist Reprod Genet

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Objective To investigate efficacy and safety of a controlled ovarian stimulation (COS) protocol in which a single dose of Corifollitropin-alfa (CFα) was administered on day 4 of a GnRH-antagonist cycle. Design Cohort case-control study. Setting University Hospital. Patients One hundred twenty-two normally cycling women expected to be normal responders to COS. Interventions In 61 patients, CFα (100-150 μg) was injected subcutaneously on day 4 of a spontaneous menstrual cycle; a GnRH-antagonist was added from day 8 (fixed protocol; 0.25 mg/day). If needed to complete follicular maturation, recombinant FSH (rFSH) daily injections (150/200 IU/day) were given from day 11. A control group of 61 matched women was stimulated with daily subcutaneous injections of rFSH (100-150 U/day) from day 4 of the cycle, and received GnRH-antagonist (0.25 mg/day) from day 8. IVF or ICSI was performed according to the sperm characteristics, and 1-2 embryos were transferred in utero under US guidance on day 2.Main outcome measures Number of retrieved cumulusoocyte complexes (COCs), clinical pregnancy rate (PR), implantation rate (IR), ongoing PR at 10 weeks, number of injections/cycle, ovarian hyperstimulation syndrome (OHSS) rate.Results No cycle was cancelled and the mean number of retrieved COCs was comparable in patients and controls. About 60 % of CF-alfa treated women had no need of daily rFSH addition, and the mean number of injections/cycle was significantly lower in the CF-alfa group than in controls (p<0.05). The ongoing PR/transfer was 36.8 % in CF-alfa group and 37.5 % in controls. No patient developed severe OHSS, and the incidence of moderate OHSS was similar in cases and controls. Conclusions CFα may be started on day 4 of the cycle obtaining results comparable to those of a COS using day 4-start daily rFSH, with significantly less injections and a similar risk of OHSS.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of late-start Corifollitropin-alfa administration for controlled ovarian hyperstimulation in IVF: a cohort, case–control study

Revelli

Pittatore

Casano

et al. 2015

J Assist Reprod Genet

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“…[10,11], т. е. заменять 7 ежедневных инъекций препаратов рФСГ. Фармакодинамические свой-ства корифоллитропина альфа изучались по уровню кон-центрации гормонов у мужчин с гипогонадотропным гипогонадизмом [12] и по уровню фолликулярного ответа и концентрации гормонов у здоровых женщин с гипофи-зарной супрессией [13], а также у пациенток с проявле-ниями олигоменореи и аменореи [14].…”

Section: ключевые словаunclassified

Corifollitropin alfa. Efficacy, safety and convenience for doctor and patient

Абляева¹,

Бендусов²

2016

Medicinskij sovet

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The efficacy and safety of the only existing corifollitropin alpha drug was compared with recombinant follicle stimulating hormone (rFSH) preparations administered for the purpose of stimulating multi-follicular growth under in vitro fertilization/intracytoplasmic sperm injection programmes. According to numerous sources, the efficacy in terms of live birth rates, clinical and ongoing pregnancy among female patients receiving corifollitropin alpha and those receiving rFSH during the first 7 days of stimulation was comparable. There were no statistical differences between the corifollitropin alfa and rFSH groups in terms of the incidence of ectopic and multiple pregnancy, risk of OHSS, embryonal/fetal malformations. The rate of antibody formation to corifollitropinu alpha was not clinically relevant. There were statistical differences in ovarian response between the groups of patients receiving corifollitropin alpha and patients taking rFSH reflected in a higher number of cumulus oocyte complexes in the corifollitropin alpha group. Patients demonstrated higher satisfaction after receiving corifollitropin alpha compared to rFSH due to a lower number of injections required.

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“…Consequently, a single subcutaneous injection of corifollitropin alfa is sufficient to induce and maintain the follicular growth up to a week, replacing seven daily gonadotropin injections during the first week of ovarian stimulation. The main advantage of corifollitropin alfa administration is the improvement of drug compliance, more over both physical and psychological burden associated with IVF treatments drop out [4].…”

Section: Introductionmentioning

confidence: 99%

The Use of Corifollitropin Alfa in Combination with a GnRH Analogue as Final Trigger in the Potential High Responders

Arnoldi¹

2014

JFIV Reprod Med Genet

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Background: A great concern exists in using corifollitropin alfa to induce ovarian stimulation in high responders due to the riskof OHSS.In this study, we utilized corifollitropin alfa in patients with the potential of being high responders, in addition to the GnRH analogue triptorelin, as final trigger to induce the oocyte maturation. An intensive luteal support was administered to allow the transfer in the same cycle. Patients and methods:Between January 2013 and September 2014, 35 patients were stimulated with corifollitropin alfa and underwent in vitro fertilization or intracytoplasmic sperm injection procedures. All women had levels of antimullerian hormone>3 ng/ml and antral follicle count >10 and <20. The patients with polycystic ovarian syndrome were excluded from the study. Results:The mean number of oocytes collected was 13.95 ± 6.04, the mean number of oocytes inseminated was 5.11 ± 1.66, the mean number of embryos obtained and transferred was 3.13 ±1.61 and 2.11 ± 0.92, respectively. All patients received a fresh embryo transfer,and the luteal phase was intensively supported by triptorelin and progesterone.A part of oocytes (2.47 ± 4.28) and blastocysts (0.39 ± 0.75) was vitrified.The clinical pregnancy was achieved in 15 patients and the ongoing pregnancy in11 women. Cumulative ongoing pregnancy rate, including the pregnancies achieved after thawing of eggs or embryos, was 39.47%. No OHSS were observed. Conclusions:Corifollitropin alfa plus triptorelin trigger elicits a safe ovarian stimulation in the potential high responderpatients. first day after insemination.Luteal phase was supportedby triptorelin 0.1 mg, one injection every other day from the embryo transfer, for a total of five injections. Additionally, 600 mg/day of micronized progesterone (Progeffik 200 mg, 3 cps/die) was started from the day of oocyte retrieval. A quantitative pregnancy test, done by dosing serum β-hCG, was performed 12 days after ovulation triggering with triptorelin and it was repeated 2 days later. In the presence of pregnancy, a transvaginal ultrasound was performed 28-32 days after the embryo transfer and repeated as required. Clinical pregnancy was confirmed if a fetal heartbeat was observed by transvaginal ultrasound. ResultsCharacteristics of ovarian stimulation and IVF/ICSI parameters are described in Table 1. Despite the patients included in this study had a high follicular response (14 women had over 15 oocytes retrieved), the ovarian stimulation protocol allowed to obtain a good fertilization rate and top-and good-quality embryos.Our results show that, in this group ofthe potential high responder patients, 15 clinical pregnancies and 11 ongoing pregnancies were achieved per fresh cycle ( Table 2). The cumulative ongoing pregnancy rate reached 39.47%, including 4 ongoing pregnancies which were obtained after the transfer of frozen-thawed oocyte (in one patient) and blastocysts (in three patients). Some of the pregnancies have already delivered the birth of a healthy baby. All patients reported good comp...

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Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency

Cited by 136 publications

References 89 publications

Efficacy and safety of late-start Corifollitropin-alfa administration for controlled ovarian hyperstimulation in IVF: a cohort, case–control study

Efficacy and safety of late-start Corifollitropin-alfa administration for controlled ovarian hyperstimulation in IVF: a cohort, case–control study

Corifollitropin alfa. Efficacy, safety and convenience for doctor and patient

The Use of Corifollitropin Alfa in Combination with a GnRH Analogue as Final Trigger in the Potential High Responders

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