Folitropin delta je moderní rekombinantní gonadotropin produkovaný na lidských buněčných liniích PER.C6 vykazující shodný glykosylační profil s lidským folikulostimulačním hormonem v porovnání s rekombinantními gonadotropiny produkovanými na zvířecích buněčných liniích. Cílem tohoto článku je podat shrnutí dosud publikovaných dat.

New recombinant gonadotropin-follitropin delta produced on human cell lines PER.C6 shows the same glycosylation profiles as human follicle stimulating hormone in comparison with recombinant gonadotropins produced on animal cell lines. The aim of the article is to summarize published data.

• MeSH
• antimülleriánský hormon MeSH
• asistovaná reprodukce MeSH
• folikuly stimulující hormon lidský * MeSH
• lidé MeSH
• ženská infertilita terapie   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH

STUDY QUESTION: Does addition of choriogonadotropin beta (recombinant CG beta) to follitropin delta increase the number of good-quality blastocysts following ovarian stimulation in a long GnRH agonist protocol? SUMMARY ANSWER: At the doses investigated, the addition of CG beta reduced the number of intermediate follicles and related down-stream parameters including the number of oocytes and blastocysts. WHAT IS KNOWN ALREADY: CG beta is a novel recombinant hCG (rhCG) molecule expressed by a human cell line (PER.C6®) and has a different glycosylation profile compared to urinary hCG or rhCG derived from a Chinese Hamster Ovary (CHO) cell line. In the first-in-human trial, the CG beta pharmacokinetics were similar between men and women. In women, the AUC and the peak serum concentration (Cmax) increased approximately dose proportionally following single and multiple daily doses. In men, a single dose of CG beta provided higher exposure with a longer half-life and proportionately higher testosterone production than CHO cell-derived rhCG. STUDY DESIGN, SIZE, DURATION: This placebo-controlled, double-blind, randomized trial (RAINBOW) was conducted in five European countries to explore the efficacy and safety of CG beta as add-on treatment to follitropin delta in women undergoing ovarian stimulation in a long GnRH agonist protocol. Randomization was stratified by centre and age (30-37 and 38-42 years). The primary endpoint was the number of good-quality blastocysts (Grade 3 BB or higher). Subjects were randomized to receive either placebo or 1, 2, 4, 8 or 12 μg CG beta added to the daily individualized follitropin delta dose during ovarian stimulation. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 620 women (30-42 years) with anti-Müllerian hormone (AMH) levels between 5 and 35 pmol/l were randomized in equal proportions to the six treatment groups and 619 subjects started treatment. All 619 subjects were treated with an individualized dose of follitropin delta determined based on AMH (Elecsys AMH Plus Immunoassay) and body weight. Triggering with rhCG was performed when 3 follicles were ≥17 mm but no more than 25 follicles ≥12 mm were reached. MAIN RESULTS AND THE ROLE OF CHANCE: The demographic characteristics were comparable between the six treatment groups and the overall mean age, body weight and AMH were 35.6 ± 3.3 years, 65.3 ± 10.7 kg and 15.3 ± 7.0 pmol/l, respectively. The incidence of cycle cancellation (range 0-2.9%), total follitropin delta dose (mean 112 μg) and duration of stimulation (mean 10 days) were similar across the groups. At stimulation Day 6, the number and size of follicles was similar between the treatment groups, whereas at the end-of-stimulation dose-related decrease of the intermediate follicles between 12 and 17 mm was observed in comparison to the placebo group. In contrast, the number of follicles ≥17 mm was similar between the CG beta dose groups and the placebo group. A reduced number of intermediate follicles (12 to 17 mm) and fewer oocytes (mean range 9.7 to 11.2) were observed for all doses of CG beta compared to the follitropin delta only group (mean 12.5). The mean number of good-quality blastocysts was 3.3 in the follitropin delta group and ranged between 2.1 and 3.0 across the CG beta groups. The incidence of transfer cancellation was higher in the 4, 8 and 12 μg group, mostly as no blastocyst was available for transfer. In the group receiving only follitropin delta, the ongoing pregnancy rate (10-11 weeks after transfer) was 43% per started cycle versus 28-39% in CG beta groups and 49% per transfer versus 38-50% in the CG beta groups. There was no apparent effect of CG beta on the incidence of adverse events, which was 48.1% in the placebo group and 39.6-52.3% in the CG beta dose groups. In line with the number of collected oocytes, the overall ovarian hyperstimulation syndrome incidence remained lower following follitropin delta with CG beta (2.0-10.3%) compared with follitropin delta only treatment (11.5%). Regardless of the dose, CG beta was safe and well-tolerated with low risk of immunogenicity. LIMITATIONS, REASONS FOR CAUTION: The effect of the unique glycosylation of CG beta and its associated potency implications in women were not known prior to this trial. Further studies will be needed to evaluate optimal doses of CG beta for this and/or different indications. WIDER IMPLICATIONS OF THE FINDINGS: The high ongoing pregnancy rate in the follitropin delta group supports the use of individualized follitropin delta dosing in a long GnRH agonist protocol. The addition of CG beta reduced the presence of intermediate follicles with the investigated doses and negatively affected all down-stream parameters. Further clinical research will be needed to assess the optimal dose of CG beta in the optimal ratio to follitropin delta to develop this novel combination product containing both FSH and LH activity for ovarian stimulation. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by Ferring Pharmaceuticals, Copenhagen, Denmark. B.M. and P.L. are employees of Ferring Pharmaceuticals. M.F.S., H.V., C.Y.A., M.F., C.B., A.P. and Y.K. have received institutional clinical trial fees from Ferring Pharmaceuticals. C.B. has received payments for lectures from Organon, Ferring Pharmaceuticals, Merck A/S and Abbott. M.F.S. has received payment for lectures from Ferring Pharmaceuticals. Y.K. has received payment for lectures from Merck and travel support from Gedeon Richter. H.V. has received consulting fees from Oxo and Obseva and travel support from Gedeon Richter, Ferring Pharmaceuticals and Merck. C.Y.A. has received payment for lectures from IBSA, Switzerland. M.F and C.Y.A. were reimbursed as members of the Data Monitoring Board in this trial. M.F. has an issued patent about unitary combination of FSH and hCG (EP1633389). TRIAL REGISTRATION NUMBER: 2017-003810-13 (EudraCT Number). TRIAL REGISTRATION DATE: 21 May 2018. DATE OF FIRST PATIENT’S ENROLMENT: 13 June 2018.

• MeSH
• antimülleriánský hormon MeSH
• CHO buňky MeSH
• choriogonadotropin MeSH
• Cricetulus MeSH
• fertilizace in vitro metody   MeSH
• folikuly stimulující hormon lidský * MeSH
• hormon uvolňující gonadotropiny MeSH
• indukce ovulace * metody   MeSH
• křečci praví MeSH
• léčivé přípravky MeSH
• lidé MeSH
• lidský choriogonadotropin, beta podjednotka MeSH
• randomizované kontrolované studie jako téma MeSH
• rekombinantní proteiny MeSH
• těhotenství MeSH
• tělesná hmotnost MeSH
• úhrn těhotenství na počet žen v reprodukčním věku MeSH
• zvířata MeSH
• Check Tag
• křečci praví MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• protokol klinické studie MeSH

RESEARCH QUESTION: How does the efficacy and safety of individualized follitropin delta dosing compare with conventional dosing for ovarian stimulation in potential high responders? DESIGN: Retrospective analysis of 153 potential high responders identified on the basis of baseline serum anti-Müllerian hormone (AMH) levels above 35 pmol/l, who were originally randomized to an individualized fixed dose of follitropin delta based on AMH and body weight (n = 78) or to a daily starting dose of 150 IU follitropin alfa (n = 75). RESULTS: At the end of stimulation, patients treated with individualized follitropin delta or conventional follitropin alfa had 12.1 ± 7.0 and 18.3 ± 7.0 (P < 0.001) follicles measuring 12 mm or wider, and 27.3% and 62.7% had serum progesterone levels higher than 3.18 nmol/l (P < 0.001), respectively. Overall number of oocytes in these two respective arms was 9.3 ± 6.7 and 17.9 ± 8.7 (P < 0.001), and the ongoing pregnancy rate per started cycle after fresh blastocyst transfer was 28.2% and 24.0%. The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both. CONCLUSIONS: Treatment with individualized follitropin delta provides an improved efficacy-safety balance in women with high ovarian reserve, as it normalizes the ovarian response and decreases the risk of OHSS without compromising the chance of pregnancy.

• MeSH
• antimülleriánský hormon krev   MeSH
• dospělí MeSH
• fertilizace in vitro metody   MeSH
• folikuly stimulující hormon lidský aplikace a dávkování   MeSH
• indukce ovulace škodlivé účinky   MeSH
• lidé MeSH
• ovariální hyperstimulační syndrom krev   etiologie   MeSH
• porodnost MeSH
• progesteron krev   MeSH
• rekombinantní proteiny aplikace a dávkování   MeSH
• retrospektivní studie MeSH
• těhotenství MeSH
• tělesná hmotnost fyziologie   MeSH
• úhrn těhotenství na počet žen v reprodukčním věku MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

Cíl: Cílem studie CERES (CzEch REkovelle real life Study) bylo shromáždit první zkušenosti s užíváním zcela nového gonadotropinu, vyhodnotit účinnost folitropinu delta v běžné české klinické praxi a srovnat získané výsledky s výstupy studie ESTHER-1. Metodika: Ovariální stimulací individualizovanou denní dávkou folitropinu delta v mikrogramech na základě hladiny antimüllerického hormonu (AMH) a tělesné hmotnosti pacientky (AMH < 15 pmol/ l: fixní dávka 12 µg/ d; AMH > 15 pmol/ l: 0,10–0,19 µg/ kg/ d; max. 12 µg/ d). Výsledky: Celkem bylo zařazeno 85 pacientek ve věku 24–42 let, průměrný věk 32,9 let, průměrná tělesná hmotnost 67,8 kg, průměrná hodnota AMH 23,2 pmol/ l. Bylo zahájeno 85 kontrolovaných ovariálních stimulací s folitropinem delta a 84 odběrů vajíček. U 40 pacientek (47 %) byl optimální zisk počtu vajíček (8–14), 75 pacientek (88 %) mělo embryotransfer, 10 (12 %) nemělo embryo vhodné k transferu. U 65 pacientek byl proveden single embryo transfer, u 10 byla transferována dvě embrya. Počet klinických gravidit byl 37 (43,5 % cPR – clinical pregnancy rate), počet porodů živého bylo plodů 30 (35,3 % LBR – live birth rate). Byly hlášeny tři (3,5 %) časné ovariální hyperstimulační syndromy (OHSS) mírného typu. Hospitalizace související s léčbou byla 0. Závěr: Individualizace ovariální stimulace vede k optimalizaci ovariální odpovědi a při zachování účinnosti zvyšuje bezpečnost léčby cestou snížení incidence OHSS. Výsledky získané u české populace jsou zcela srovnatelné s výstupy velké mezinárodní randomizované zaslepené klinické zkoušky ESTHER-1.

Objective: The aim of the study CERES (CzEch REkovelle real life Study) was to gather experience with the use of a novel gonadotrophine, to evaluate the efficacy of follitropin delta in Czech clinical settings and to compare our results with the clinical trial ESTHER-1. Methods: Individualized follitropin delta daily dose in µg based on the patient's anti-Müllerian hormone (AMH) level and body weight (AMH < 15 pmol/ L: 12 µg/ d; AMH > 15 pmol/ L: 0.10–0.19 µg/ kg/ d; max. 2 µg/ d). Results: A total of 85 women (aged 24–42 years) was included in the study. The average patient's age was 32.9 years, the average body weight was 67.8 kg, and the mean level of AMH was 23.2 pmol/ L. There were initiated 85 controlled ovarian stimulations with follitropin delta and 84 egg collections. Forty patients (47%) had optimal number of retrieved eggs (8–14), 75 patients (88%) had embryotransfer, 10 patients (12%) had no embryo suitable for transfer, 65 patients had single embryo transfer and 10 patients had 2 embryos for transfer. There were reported 37 clinical pregnancies (43.5% cPR – clinical pregnancy rate), 30 live births (35.3% LBR – live birth rate), 3 (3.5%) early moderate ovarian hyperstimulation syndroms (OHSS) and no hospitalization due to the treatment. Conclusion: Individualized ovarian stimulation optimizes ovarian response, maintains treatment efficacy and improves safety by reducing OHSS incidence. The results of the Czech population study are fully comparable with the international, randomized, assessor-blinded trial ESTHER-1.

• Klíčová slova
• studie CERES,
• MeSH
• antimülleriánský hormon MeSH
• fertilizace in vitro * MeSH
• folikuly stimulující hormon lidský MeSH
• gonadotropiny MeSH
• individualizovaná medicína MeSH
• indukce ovulace * MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• ovariální hyperstimulační syndrom MeSH
• prospektivní studie MeSH
• rekombinantní proteiny MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH

RESEARCH QUESTION: Is individualization of dosing with follitropin delta in sequential ovarian stimulation cycles an effective preventive strategy for ovarian hyperstimulation syndrome risk? If so, for which patients does an individualized strategy provide the greatest OHSS risk reduction and/or the need for additional preventive interventions? DESIGN: A secondary analysis of three ovarian stimulation cycles in IVF/intracytoplasmic sperm injection patients included in one randomized, assessor-blinded trial comparing two recombinant FSH preparations (ESTHER-1, NCT01956110), and a second trial in women undergoing up to two additional cycles (ESTHER-2, NCT01956123). Of 1326 women (aged 18-40 years) randomized and treated with follitropin delta or alfa in cycle 1, 513 continued to cycle 2 and 188 to cycle 3. Follitropin delta and alfa doses were maintained/adjusted according to ovarian response in the previous cycle. RESULTS: Individualized dosing with follitropin delta significantly reduced moderate/severe OHSS and/or preventive interventions (P=0.018) versus conventional dosing with follitropin alfa in patients undergoing up to three ovarian stimulation cycles. The greatest benefit was observed in patients in the highest anti-Müllerian hormone (AMH) quartile (P=0.012). On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa. CONCLUSION: An individualized follitropin delta dosing regimen decreased the risk of moderate/severe OHSS as well as the incidence of preventive interventions versus a conventional follitropin alfa regimen. An analysis per AMH quartile indicated that these statistically significant differences are driven mainly by patients with the highest pretreatment AMH levels.

• MeSH
• dospělí MeSH
• fertilizace in vitro MeSH
• folikuly stimulující hormon lidský aplikace a dávkování   terapeutické užití   MeSH
• indukce ovulace * škodlivé účinky   MeSH
• interpretace statistických dat MeSH
• intracytoplazmatické injekce spermie MeSH
• kryoprezervace MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• ovariální hyperstimulační syndrom prevence a kontrola   MeSH
• ovarium účinky léků   MeSH
• rekombinantní proteiny aplikace a dávkování   terapeutické užití   MeSH
• riziko MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

• MeSH
• choriogonadotropin aplikace a dávkování   MeSH
• fertilizace in vitro * metody   MeSH
• folikuly stimulující hormon lidský aplikace a dávkování   MeSH
• hormon uvolňující gonadotropiny analogy a deriváty   aplikace a dávkování   MeSH
• indukce ovulace * metody   MeSH
• lidé MeSH
• luteální fáze účinky léků   MeSH
• medroxyprogesteron aplikace a dávkování   MeSH
• progestiny aplikace a dávkování   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH

Cíl práce: Zhodnotit výsledky ovariální stimulace corifollitropinem alfa (Elonva) na neselektovaném souboru žen poprvé stimulovaných v programu mimotělního oplodnění (IVF) ve srovnání s výsledky u selektovaných souborů ve velkých randomizovaných studiích. Typ studie: Prospektivní studie. Název a sídlo pracoviště: Sanatorium Pronatal, Praha. Metodika: Hodnoceny jsou výsledky u 40 žen s adekvátní ovariální rezervou poprvé léčených v programu IVF po stimulaci corifollitropinem alfa a antagonisty GnRH. Průměrný věk žen ve studii byl 32,8 let (29–42 roků), ženám mladším než 36 let s hmotností méně než 60 kg byla aplikována druhý den cyklu Elonva 100 ?g, všem ostatním (věk > 36 let, hmotnost > 60 kg) Elonva 150 ?g. Za 120 hodin po punkci folikulů bylo do dělohy přeneseno jedno embryo (single embryo transfer – eSET). Výsledky jsme porovnali s výsledky velkých randomizovaných studií. Výsledky: Po stimulaci corifollitropinem alfa a antagonisty GnRH bylo získáno 10,6 (9,2 ? 4,2) vajíček, z nichž 7,3 (6,6 ? 3,9) bylo zralých M II oocytů (68,9 %), a oplozeno 84,6 %. Po prvním přenosu (čerstvá embrya + embrya z cyklů „vše kryo“) bylo dosaženo 14 gravidit (37,8 %), z následných kryotransferů byla dosažena další tři těhotenství (kumulativní úspěšnost 45,9 %). Ze 17 gravidit tři těhotenství skončila neúspěšně potratem. U žádné z pacientek se nerozvinul závažný hyperstimulační syndrom. Dosažené výsledky na neselektovaném souboru žen poprvé stimulovaných v programu mimotělního oplodnění jsou zcela srovnatelné s výsledky publikovaných randomizovaných studií. Závěr: Stimulační protokol kombinující corifollitropin alfa s antagonisty GnRH lze úspěšně použít u žen poprvé stimulovaných v programu mimotělního oplodnění.

Objectives: To compare results after stimulation with corifollitropin alfa (Elonva) in unselected group of women entering for the first time in in vitro fertilization programme (IVF) with results from Phase III randomized trials with selected groups of women. Design: Prospective study. Setting: Sanatorium Pronatal, Praha. Methods: 40 unselected women with adequat ovarian reserve entering for the first time in IVF programme were stimulated with corifollitropin alfa and GnRH antagonists. Avarage age in the study group was 32,8 years (29–42 years), women younger then 36 and less then 60 kg received Elonva 100 ?g , all others (age > 36 let, weight > 60 kg) Elonva 150 ?g. Five days after egg retrieval one blastocyst was transferred (single embryo transfer – eSET). Our results were compared with the resuls in higly selected groups of women from Phase III randomized trials. Results: After stimulation with corifollitropin alfa and GnRH antagonists on average 10,6 (9,2 ? 4,2) eggs could be retrieved, among them 7,3 (6,6 ? 3,9) were M II oocytes (68,9%) and fertilisation rate was 84,6%. After first embryo transfer („fresh“ embryos and embryos from „freeze all“ cycles) 14 pregnancies were achieved (37,8%), three pregnancies were achieved later from transfer of frozen-thawed embryos (cumulative pregnancy rate 45,9%). There were three abortions. No severe hyperstimulation syndrom occured. Our results in unselected group of women stimulated for the first in an IVF programme with corifollitropin alfa are fully comparable with results published in randomized trials with selected group of patiens. Conclusion: Corifollitropin alfa in combination with daily GnRH antagonist can be successfully used in normal-responder patients stimulated for the first time in an IVF programme

• Klíčová slova
• corifollitropin alfa, antagonista GnRH,
• MeSH
• asistovaná reprodukce MeSH
• folikuly stimulující hormon - beta-podjednotka terapeutické užití   MeSH
• folikuly stimulující hormon lidský terapeutické užití   MeSH
• indukce ovulace * metody   MeSH
• lidé MeSH
• prospektivní studie MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH

The incidence of low (<6 oocytes) and high (>18 oocytes) ovarian response to 150 µg corifollitropin alfa in relation to anti-Müllerian hormone (AMH) and other biomarkers was studied in a multi-centre (n = 5), multi-national, prospective, investigator-initiated, observational cohort study. Infertile women (n = 212), body weight >60 kg, underwent controlled ovarian stimulation in a gonadotrophin-releasing hormone-antagonist multiple-dose protocol. Demographic, sonographic and endocrine parameters were prospectively assessed on cycle day 2 or 3 of a spontaneous menstruation before the administration of 150 µg corifollitropin alfa. Serum AMH showed the best correlation with the number of oocytes obtained among all predictor variables. In receiver-operating characteristic analysis, AMH at a threshold of 0.91 ng/ml showed a sensitivity of 82.4%, specificity of 82.4%, positive predictive value 52.9%and negative predictive value 95.1% for predicting low response (area under the curve [AUC], 95% CI; P-value: 0.853, 0.769-0.936; <0.0001). For predicting high response, the optimal threshold for AMH was 2.58 ng/ml, relating to a sensitivity of 80.0%, specificity 82.1%, positive predictive value 42.5% and negative predictive value 96.1% (AUC, 95% CI; P-value: 0.871, 0.787-0.955; <0.0001). In conclusion, patients with serum AMH concentrations between approximately 0.9 and 2.6 ng/ml were unlikely to show extremes of response.

• MeSH
• dospělí MeSH
• folikuly stimulující hormon lidský farmakologie   MeSH
• hormon uvolňující gonadotropiny antagonisté a inhibitory   MeSH
• lidé MeSH
• ovarium účinky léků   MeSH
• prospektivní studie MeSH
• rozvrh dávkování léků MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

OBJECTIVE: To evaluate the dose-response relationship of a novel recombinant human FSH (rhFSH; FE 999049) with respect to ovarian response in patients undergoing IVF/intracytoplasmic sperm injection treatment; and prospectively study the influence of initial antimüllerian hormone (AMH) concentrations. DESIGN: Randomized, controlled, assessor-blinded, AMH-stratified (low: 5.0-14.9 pmol/L [0.7-<2.1 ng/mL]; high: 15.0-44.9 pmol/L [2.1-6.3 ng/mL]) trial. SETTING: Seven infertility centers in four countries. PATIENT(S): Two hundred sixty-five women aged ≤37 years. INTERVENTION(S): Controlled ovarian stimulation with either 5.2, 6.9, 8.6, 10.3, or 12.1 μg of rhFSH, or 11 μg (150 IU) of follitropin alfa in a GnRH antagonist cycle. MAIN OUTCOME MEASURE(S): Number of oocytes retrieved. RESULT(S): The number of oocytes retrieved increased in an rhFSH dose-dependent manner, from 5.2 ± 3.3 oocytes with 5.2 μg/d to 12.2 ± 5.9 with 12.1 μg/d. The slopes of the rhFSH dose-response curves differed significantly between the two AMH strata, demonstrating that a 10% increase in dose resulted in 0.5 (95% confidence interval 0.2-0.7) and 1.0 (95% confidence interval 0.7-1.3) more oocytes in the low and high AMH stratum, respectively. Fertilization rate and blastocyst/oocyte ratio decreased significantly with increasing rhFSH doses in both AMH strata. No linear relationship was observed between rhFSH dose and number of blastocysts overall or by AMH strata. Five cases of ovarian hyperstimulation syndrome were reported for the three highest rhFSH doses and in the high AMH stratum. CONCLUSION(S): Increasing rhFSH doses results in a linear increase in number of oocytes retrieved in an AMH-dependent manner. The availability of blastocysts is less influenced by the rhFSH dose and AMH level. CLINICAL TRIAL REGISTRATION NUMBER: NCT01426386.

• MeSH
• antimülleriánský hormon aplikace a dávkování   MeSH
• dospělí MeSH
• fertilizace in vitro metody   MeSH
• folikuly stimulující hormon lidský aplikace a dávkování   MeSH
• indukce ovulace metody   MeSH
• intracytoplazmatické injekce spermie metody   MeSH
• lidé MeSH
• odběr oocytu * MeSH
• rekombinantní proteiny aplikace a dávkování   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

To evaluate whether a short follicular phase of ovarian stimulation compromises the chance of pregnancy, subjects from a double-blind, randomized trial treated with a single dose of corifollitropin alfa (n=756) or daily recombinant FSH (n=750) were categorized as early responders if three follicles ≥17 mm were reached and human chorionic gonadotrophin (HCG) was administered prior to or on stimulation day 8, and as normal responders if three follicles ≥17 mm were reached and HCG was administered after stimulation day 8. In the corifollitropin alfa and recombinant FSH groups, 23.2% and 29.1%, respectively, were early responders (P=0.01). Regardless of the treatment group, the initial ovarian response was higher in early responders, but with two extra days of stimulation, the number and size of follicles on the day of HCG in the normal responders was similar to those of the early responders. The number of oocytes was similar in both response groups following corifollitropin alfa treatment (13.6 versus 14.5) and recombinant FSH treatment (12.8, both groups). The ongoing pregnancy rates were comparable for early and normal responders regardless of the treatment group, supporting successful outcome following a stimulation period of only 1 week.

• MeSH
• časové faktory MeSH
• choriogonadotropin aplikace a dávkování   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• folikulární fáze fyziologie   MeSH
• folikuly stimulující hormon lidský aplikace a dávkování   MeSH
• folikuly stimulující hormon aplikace a dávkování   MeSH
• indukce ovulace metody   MeSH
• lidé MeSH
• rekombinantní proteiny aplikace a dávkování   MeSH
• retrospektivní studie MeSH
• těhotenství MeSH
• úhrn těhotenství na počet žen v reprodukčním věku MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH