FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who developed OHSS or were at risk of OHSS in a previous cycle, the daily dose for the subsequent cycle is 33% lower than the dose used in the cycle where OHSS or risk of OHSS occurred.
Croatian: U bolesnica koje razviju OHSS ili kod kojih je u prethodnom ciklusu postojao rizik od OHSS-a, dnevna je doza kod sljedećeg ciklusa 33% niža od doze koja je primijenjena u ciklusu tijekom kojega se javio ili je postojao rizik od OHSS-a.
English: For storage conditions after first use of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prve primjene lijeka vidjeti u dijelu 6.3.
English: The dose is to be rounded off to the nearest 0.33 micrograms to match the dosing scale on the injection pen.
Croatian: Dozu je potrebno zaokružiti na najbližih 0,33 mikrograma da bi odgovarala dozirnoj skali na brizgalici za injekciju.
English: The dose of REKOVELLE is individualised for each patient to obtain an ovarian response with favourable safety/efficacy profile.
Croatian: Doza lijeka REKOVELLE je individualizirana za svaku bolesnicu da bi se postigao odgovor jajnika s povoljnim profilom sigurnosti/djelotvornosti.
English: If the recommended dose and schedule of administration are followed, ovarian hyperstimulation syndrome is less likely.
Croatian: Ako slijedite preporučenu dozu i raspored primjene, vjerojatnost razvoja sindroma hiperstimulacije jajnika je manja.
English: • This medicine should be given by injection just under the skin (subcutaneously) in the stomach-area (abdomen).
Croatian: • Ovaj lijek se mora primijeniti injiciranjem odmah ispod kože (potkožno) u predjelu trbuha (abdomen).
English: The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation syndrome (OHSS).
Croatian: Doziranje lijeka REKOVELLE je individualizirano za svaku bolesnicu s ciljem da se dobije odgovor jajnika koji je povezan sa povoljnim profilom sigurnosti/djelotvornosti, odnosno, s ciljem dobivanja odgovarajućeg broja oocita i smanjenja broja intervencija da se spriječi sindrom hiperstimulacije jajnika (OHSS, engl. ovarian hyperstimulation syndrome).
English: In the following situations, treatment outcome is unlikely to be favourable, and therefore REKOVELLE should not be administered:
Croatian: U sljedećim situacijama nije vjerojatno da će ishod liječenja biti povoljan zbog čega se REKOVELLE
English: Repeated treatment with REKOVELLE of patients with pre-existing or treatment-induced anti-FSH antibodies did not increase the antibody titre, was not associated with decreased ovarian response, and did not induce immune-related adverse events.
Croatian: Ponovljeno liječenje s lijekom REKOVELLE u bolesnica s već postojećim ili liječenjem uzrokovanim anti-FSH antitijelima nije povećao titar antitijela i nije bio povezan sa smanjenim odgovorom jajnika te nije uzrokovao nuspojave povezane s imunološkim sustavom.
English: The apparent volume of distribution is about 25 L after subcutaneous administration and the volume of distribution at steady state is 9 L after intravenous administration.
Croatian: Prividni volumen distribucije je oko 25 L nakon supkutane primjene, a volumen distribucije u stanju dinamičke ravnoteže je 9 L nakon intravenske primjene.
English: If you have a history of tubal disease, you have an increased risk of ectopic pregnancy.
Croatian: Ako ste ranije imali bolest jajovoda, imate povišen rizik od ektopične trudnoće.
English: Twisting of the ovary could cut off the blood flow to the ovary.
Croatian: Uvrnuće jajnika može prekinuti dotok krvi prema jajniku.
English: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
Croatian: Kad je Vaš spremnik za odlaganje oštrih predmeta gotovo pun, morate slijediti nacionalne smjernice za pravilno odlaganje spremnika za odlaganje oštrih predmeta.
English: Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider.
Croatian: Nemojte si pokušati ubrizgati lijek dok Vam zdravstveni djelatnik nije pokazao ispravan način za ubrizgavanje lijeka.
English: The impact of the AMH-based dosing regimen of REKOVELLE was also assessed in secondary endpoints, such as ovarian response and OHSS risk management.
Croatian: Utjecaj režima doziranja lijeka REKOVELLE temeljenog na AMH također je bio ocijenjen u mjerama sekundarnog ishoda, kao što su odgovor jajnika i zbrinjavanje rizika od OHSS-a.
English: These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies after treatment with follitropin alfa.
Croatian: Ove stope su bili slične incidenciji već postojećih anti-FSH antitijela prije izlaganja lijeku REKOVELLE u 1. ciklusu koja je bila 1,4% i usporediva s incidencijom anti-FSH antitijela nakon liječenja s folitropinom alfa.
English: Ovarian torsion and thromboembolic events are known to be rare complications of ovarian stimulation treatment (see section 4.4).
Croatian: Torzija jajnika i tromboembolija poznati su kao rijetke komplikacije kod liječenja stimulacijom jajnika (vidjeti dio 4.4).
English: Among patients with AMH ≥15 pmol/L, the ovarian response with REKOVELLE (N=355) and follitropin alfa (N=353), respectively, was as follows: mean number of oocytes retrieved 11.6 ± 5.9 and 13.3 ± 6.9, and proportion of patients with ≥20 oocytes 10.1% (36/355) and 15.6% (55/353).
Croatian: Među bolesnicama s AMH ≥15 pmol/L, odgovor jajnika kod primjene lijeka REKOVELLE (N=355), odnosno, folitropina alfa (N=353), bio je kako slijedi: srednji broj dobivenih oocita bio je 11,6 ± 5,9 i 13,3 ± 6,9, a udio bolesnica s ≥20 oocita 10,1% (36/355) i 15,6% (55/353).
English: Other medical conditions
Croatian: Druga medicinska stanja
English: Blood clotting problems (thromboembolic events)
Croatian: Problemi sa zgrušavanjem krvi (tromboembolija)
English: • Holding the injection button for 5 seconds allows for the full dose to be injected and absorbed under your skin.
Croatian: • Držanje dugmeta za injiciranje pritisnutim kroz 5 sekundi omogućuje da se puna doza injicira i apsorbira ispod kože.
English: In ovulatory patients with polycystic ovaries, the incidence of early moderate/severe OHSS and/or preventive interventions for early OHSS was 7.7% with REKOVELLE and 26.7% with follitropin alfa.
Croatian: U bolesnica koje imaju ovulaciju i policistične jajnike, incidencija ranog srednjeg/teškog OHSS-a i/ili preventivnih intervencija za rani OHSS bila je 7,7% kod primjene lijeka REKOVELLE i 26,7% kod primjene folitropina alfa.
English: Follitropin delta had a negative effect on fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day which is above the recommended maximal dose in humans.
Croatian: Folitropin delta ima negativan utjecaj na plodnost i rani embrionalni razvoj u štakora kod primjene doza ≥0,8 mikrograma/kg/dan što je više od preporučene maksimalne doze za ljude.
English: The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or decrease your daily dose.
Croatian: Doza lijeka REKOVELLE je stalna tijekom čitavog perioda liječenja, bez prilagodbi na način da se dnevna doza povisuje ili snižava.
English: The ESTHER-1 trial was a randomised, assessor-blinded, controlled trial in 1,326 IVF/ICSI patients.
Croatian: Kliničko ispitivanje ESTHER-1 bilo je randomizirano, slijepo za ocjenitelja, kontrolirano ispitivanje u 1326 IVF/ICSI bolesnica.
English: • The number ‘0' is lined up with the dose indicator.
Croatian: • Broj “0” je u liniji s pokazivačem doze.
English: The effect of an overdose is unknown, nevertheless, there is a risk that OHSS may occur (see section 4.4).
Croatian: Učinak predoziranja je nepoznat, ipak, postoji rizik od pojave OHSS-a (vidjeti dio 4.4).
English: Excessive ovarian response to gonadotropin treatment seldom gives rise to OHSS unless hCG is administered to trigger final follicular maturation.
Croatian: Pretjeran odgovor jajnika na liječenje gonadotropinima rijetko dovodi do OHSS-a, osim ako se ne primijeni hCG radi indukcije konačnog sazrijevanja folikula.
English: • Breast complaints (include breast pain, breast tenderness)
Croatian: • Tegobe s dojkama (uključujući bol u dojkama, osjetljivost dojki)
English: The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with gonadotropins) in your blood and your body weight.
Croatian: Dozu lijeka REKOVELLE za prvi ciklus Vašeg liječenja odredit će liječnik temeljem razine antiMüllerovog hormona (AMH, pokazatelj kako će Vaši jajnici odgovoriti na stimulaciju gonadotropinima) u Vašoj krvi i Vaše tjelesne težine.
English: The resulting REKOVELLE dosing regimen is in section 4.2.
Croatian: Posljedični režim doziranja lijeka REKOVELLE naveden je u dijelu 4.2.
English: For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration (Table 1).
Croatian: Za žene s AMH ≥15 pmol/L dnevna se doza smanjuje od 0,19 do 0,10 mikrograma/kg povećanjem koncentracije AMH (Tablica 1).
English: Within the therapeutic dose range, exposure to follitropin delta increases proportionally with the dose.
Croatian: U rasponu terapijske doze, izloženost folitropinu delta raste proporcionalno dozi.
English: • Always store the pen with the pen cap on and without a needle attached.
Croatian: • Uvijek čuvajte Vašu brizgalicu sa zatvaračem na njoj i bez pričvršćene igle.
English: Pregnancy outside the uterus (ectopic pregnancy)
Croatian: Vanmaternična trudnoća (ektopična trudnoća)
English: The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH concentration.
Croatian: Broj dobivenih oocita se povećava s dozom lijeka REKOVELLE i koncentracijom AMH u serumu.
English: If you need additional needles contact your healthcare provider.
Croatian: Ukoliko trebate dodatne igle, obratite se zdravstvenom djelatniku.
English: • primary ovarian failure
Croatian: • primarno zatajenje jajnika
English: Safety, efficacy and pharmacokinetics of REKOVELLE in patients with renal or hepatic impairment have not been specifically studied in clinical trials.
Croatian: Sigurnost, djelotvornost i farmakokinetika lijeka REKOVELLE u bolesnica s oštećenjem bubrega ili jetre nisu posebno ispitani u kliničkim ispitivanjima.
English: • have difficulty in breathing
Croatian: • otežano dišete
English: It is not known if treatment with fertility medicines increase the risk of these tumours in infertile women.
Croatian: Nije poznato povećava li liječenje lijekovima za plodnost rizik od tih tumora u neplodnih žena.
English: Using the pen incorrectly could result in receiving an incorrect dose of medicine.
Croatian: Pogrešna upotreba brizgalice mogla bi rezultirati pogrešnim doziranjem lijeka.
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Croatian: Određen stupanj povećanja jajnika očekivana je posljedica kontrolirane stimulacije jajnika.
English: • If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears.
Croatian: • Ukoliko se kapljica nije pojavila, ponovite Korake 7 do 9 (Priprema) dok se kapljica ne pojavi.
English: • Always remove the needle after every use.
Croatian: Napomena: • Uvijek uklonite iglu nakon svake primjene.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive
English: • Hold the pen so the dose display window is visible during injection.
Croatian: • Držite brizgalicu na način da je prozorčić za prikaz doze vidljiv za vrijeme injiciranja.
English: REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of hormones called gonadotropins.
Croatian: REKOVELLE sadrži folitropin delta, folikulostimulirajući hormon koji pripada skupini hormona pod nazivom gonadotropini.
English: E.J.
Croatian: Malta E.J.
English: It may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.
Croatian: To može biti povezano s drugim faktorima rizika kao što su OHSS, trudnoća, prethodna operacija abdomena, prethodni slučajevi torzije jajnika, prethodna ili postojeća cista na jajniku, te policistični jajnici.
English: REKOVELLE has no or negligible influence on the ability to drive and use machines.
Croatian: REKOVELLE ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Use of results obtained with other assays than the ELECSYS AMH Plus immunoassay from Roche for REKOVELLE dose determination is not recommended, as there currently is no standardisation of available AMH assays.
Croatian: AMH Plus imunotestom proizvođača Roche u svrhu određivanja doze lijeka REKOVELLE se ne preporuča s obzirom da trenutno nema standardizacije dostupnih AMH testova.
English: In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age, although twin pregnancy can in rare occasions develop from single embryo transfers.
Croatian: U bolesnica koje su podvrgnute MPO postupcima, rizik od višeplodne trudnoće je većinom povezan s brojem prenesenih embrija, njihovoj kakvoći i dobi bolesnice, iako se blizanačka trudnoća može u rijetkim slučajevima razviti i iz prijenosa jednog embrija.
English: Self-administration should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Croatian: Samo dobro motivirane, adekvatno obučene bolesnice koje imaju pristup savjetu stručnjaka, smiju samostalno primjenjivati lijek.
English: Patients must be educated on how to use the REKOVELLE injection pen and to perform injections.
Croatian: Bolesnice je potrebno educirati o uporabi REKOVELLE brizgalice za injekciju i primjeni injekcije.
English: • you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian disease)
Croatian: • ako imate povećane jajnike ili ciste na jajnicima (osim ako nisu uzrokovane sindromom policističnih jajnika)
English: For subsequent treatment cycles, the daily dose of REKOVELLE should be maintained or modified according to the patient's ovarian response in the previous cycle.
Croatian: Kod sljedećih je ciklusa liječenja dnevnu dozu lijeka REKOVELLE potrebno održavati ili modificirati ovisno o odgovoru jajnika bolesnice u prethodnom ciklusu.
English: • fibroid tumours of the uterus incompatible with pregnancy
Croatian: • fibroidini tumori maternice koji nisu kompatibilni s trudnoćom
English: Following daily administration of equal IU doses of REKOVELLE and follitropin alfa as determined in the rat in vivo bioassay (Steelman-Pohley assay), higher ovarian response (i.e. estradiol, inhibin B and follicular volume) was observed in patients after administration of REKOVELLE compared to follitropin alfa.
Croatian: Nakon svakodnevne primjene jednakih doza u IU lijeka REKOVELLE i folitropina alfa, kako je određeno u in vivo bioispitivanju na štakorima (Steelman-Pohley ispitivanje), opažen je veći odgovor jajnika (odnosno estradiol, inhibin B i volumen folikula) u bolesnika nakon primjene lijeka REKOVELLE u usporedbi s folitropinom alfa.
English: The instructions for using the pre-filled pen must be followed carefully.
Croatian: Upute za uporabu napunjene brizgalice moraju se pažljivo slijediti.
English: Marketing Authorisation Holder Ferring Pharmaceuticals A/S Kay Fiskers Plads 11
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Ferring Pharmaceuticals A/S Kay Fiskers Plads 11
English: • upright and stable during use,
Croatian: • je uspravan i stabilan tijekom upotrebe, • je otporan na curenje, i
English: The REKOVELLE dose is stated in micrograms.
Croatian: Doza lijeka REKOVELLE je izražena u mikrogramima.
English: For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight.
Croatian: Za žene s AMH <15 pmol/L dnevna doza je 12 mikrograma, neovisno o tjelesnoj težini.
English: • Inject the remaining dose of medicine (the number in column C) using your new pen to complete your prescribed dose.
Croatian: • Injicirajte preostalu dozu lijeka (broj u stupcu C) uz upotrebu nove brizgalice kako biste upotpunili Vašu propisanu dozu.
English: There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol (see section 5.1).
Croatian: Nema iskustva s kliničkim ispitivanjima lijeka REKOVELLE u dugotrajnom protokolu liječenja GnRH agonistom (vidjeti dio 5.1).
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Croatian: Kongenitalne malformacije Prevalencija kongenitalnih malformacija nakon MPO-a može biti nešto viša nego u slučaju spontanog začeća.
English: Examples of how to dial a dose
Croatian: Primjeri kako odabrati dozu
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Croatian: Vrlo rijetko, teški OHSS može biti popraćen komplikacijama kao što su torzija jajnika ili tromboembolijama kao što su plućna embolija, ishemijski moždani udar ili infarkt miokarda.
English: For instructions on the administration with the pre-filled pen, see the ”Instructions for Use”.
Croatian: Za upute o primjeni napunjene brizgalice vidjeti ''Upute za uporabu''.
English: • Ovarian hyperstimulation syndrome (see above)
Croatian: • Sindrom hiperstimulacije jajnika (pogledajte odlomak iznad)
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane u opadajućem nizu prema ozbiljnosti.
English: In general, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 250 micrograms or 5,000 IU for final development of the follicles.
Croatian: Općenito, jednokratno će Vam se primijeniti injekcija lijeka naziva humani korionski gonadotropin (hCG) u dozi od 250 mikrograma ili 5000 IU u svrhu završnog razvoja folikula.
English: • you have kidney or liver disease
Croatian: • imate bolest bubrega ili jetre
English: The trial demonstrated that REKOVELLE was at least as effective as follitropin alfa in terms of ongoing pregnancy rate and ongoing implantation rate, as shown in Table 3.
Croatian: Kliničko ispitivanje je dokazalo da je lijek REKOVELLE u najmanju ruku djelotvoran koliko i folitropin alfa u smislu stope trudnoće u tijeku i stope implantacije u tijeku, kako je prikazano u Tablici 3.
English: Examples of how to dial a dose using your REKOVELLE pre-filled pen The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses, and what the dose display window looks like for the prescribed doses.
Croatian: Primjeri kako odabrati dozu pri korištenju REKOVELLE napunjene brizgalice Grafički prikaz dolje prikazuje primjere propisanih doza, kako odabrati propisane doze i kako izgleda prikaz propisane doze u prozorčiću za prikaz doze.
English: • Only use the single-use click-on needles supplied with the pen.
Croatian: • Koristite samo jednokratne igle za spajanje na brizgalicu koje se isporučuju s brizgalicom.
English: Elderly There is no relevant use of REKOVELLE in the elderly population.
Croatian: Nema relevantne primjene lijeka REKOVELLE u starijoj populaciji.
English: The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the pivotal clinical trials according to MedDRA system organ class and frequency as follows: common
Croatian: Tablica niže (Tablica 2) pokazuje nuspojave u bolesnika liječenih lijekom REKOVELLE u pivotalnim kliničkim ispitivanjima prema MedDRA klasifikaciji organskih sustava i učestalosti kako slijedi: često
English: Before use:
Croatian: Prije primjene:
English: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Croatian: U žena s bolešću jajovoda u anamnezi postoji rizik od ektopične trudnoće, neovisno je li trudnoća nastupila spontanim začećem ili nakon liječenja neplodnosti.
English: • If you are not able to dial your complete dose, this means there is not enough medicine left in the pen.
Croatian: • Ukoliko niste u mogućnosti odabrati Vašu potpunu dozu, to znači da nije ostalo dovoljno lijeka u brizgalici.
English: • Do not use the pen after the month of expiration (EXP) printed on the pen label.
Croatian: • Nemojte koristiti brizgalicu nakon isteka mjeseca označenog u roku valjanosti (EXP) na naljepnici brizgalice.
English: Multiple pregnancy carries an increased risk of adverse maternal and perinatal outcomes.
Croatian: Višeplodna trudnoća donosi povećan rizik od neželjenih posljedica za majku i neželjenih perinatalnih posljedica.
English: It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Croatian: Obuhvaća izrazito povećanje jajnika, visoku razinu spolnih steroida u serumu i povećanu vaskularnu propusnost što može dovesti do nakupljanja tekućine u peritonealnoj, pleuralnoj i rijetko, perikardijalnoj šupljini.
English: • Column A shows an example of a prescribed dose.
Croatian: • Stupac A prikazuje primjer propisane doze.
English: After daily subcutaneous administration of REKOVELLE, the time to maximum serum concentration is 10 hours.
Croatian: Nakon svakodnevne supkutane primjene lijeka REKOVELLE, najviša koncentracija u serumu postiže se za 10 sati.
English: Store at or below 25 °C.
Croatian: Čuvati na temperaturi od ili ispod 25 °C.
English: The amino acid sequences of the two FSH subunits in follitropin delta are identical to the endogenous human FSH sequences.
Croatian: Slijed aminokiselina u obje podjedinice FSH kod folitropina delta jednak je slijedu kod endogenog humanog FSH.
English: • Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).
Croatian: • Odvrnite iglu u smjeru obrnutom od kazaljke na satu kako biste je odvojili od brizgalice (B+C).
English: Furthermore, the risk of birth defects may be slightly higher following infertility treatment, which is thought to be due to characteristics of the parents (such as your age, and your partner's sperm characteristics) and multiple pregnancy.
Croatian: Nadalje, rizik od urođenih mana može biti nešto viši u slučaju liječenja neplodnosti, što se smatra posljedicom karakteristika roditelja (kao što su dob i karakteristike partnerove sperme) i višeplodne trudnoće.
English: Needles are supplied with your pen.
Croatian: Igle se isporučuju zajedno s Vašom brizgalicom.
English: • The cartridge in the pen may not have enough medicine left to deliver the prescribed dose.
Croatian: • Uložak u brizgalici možda više ne sadrži dovoljno lijeka za propisanu dozu.
English: In patients with excessive follicular development (of ≥25 follicles ≥12 mm), treatment with REKOVELLE should be stopped and triggering of final follicular maturation with hCG should not be performed.
Croatian: U bolesnica s prekomjernim razvojem folikula (od ≥ 25 folikula ≥12 mm), liječenje lijekom REKOVELLE treba prekinuti, bez pokretanja završnog sazrijevanja folikula s hCG.