Recombinant FSH versus highly purified urinary FSH in patients with polycystic ovary syndrome undergoing ICSI cycles: a prospective randomized study

Abstract

Objective: To compare efficacy and safety of recombinant follicule stimulating hormone (r-FSH) and highly purified urinary FSH (HP-uFSH) in polycystic ovary syndrome (PCOS) patients undergoing intracytoplasmic sperm injection (ICSI). Method: This was a prospective randomized study conducted at Kocaeli University Faculty of Medicine, Department of Obstetrics and Gynecology, in vitro fertizilization (IVF) Unit. A total of 91 PCOS patients undergoing ICSI were randomly assigned to receive either r-FSH (n = 46) or HPuFSH (n = 45) with a gonadotropin releasing hormone (GnRH) antagonist protocol. The main outcome measures were the number of mature oocytes retrieved, embryo quality, pregnancy rates, implantation rates. Results: The number of mature oocytes retrieved, fertilization rates, the number of cryopreserved embryos were significantly higher in r-FSH group (p = 0.024, p = 0.023, p = 0.026 respectively) while the total dose of FSH used was significantly lower in the same group (p = 0.023). Pregnancy rates, clinical pregnancy rates were higher in r-FSH group although not statistically significant (52.2% versus 35.6%, p = 0.11, 37% versus 28.9%, p = 0.41 respectively). Overall therapy costs per clinical pregnancy were associated with a 9.94% increase in r-FSH group whereas costs per pregnancy were not different between groups. Conclusion: r-FSH is superior than HP-uFSH in PCOS regarding fertilization rates, the number of mature oocytes retrieved and cryopreserved embryos, pregnancy rates although overall therapy costs per clinical pregnancy are higher. Keywords: ART, HP-uFSH, PCOS, rec-FSH Amac: ICSI uygulanan PCOS hastalarinda rekombinant FSH (r-FSH) ve yuksek oranda saflastirilmis uriner FSH'nin (HP-uFSH) etkinligini ve guvenligini karsilastirmaktir. Yontem: Kocaeli Universitesi Tip Fakultesi Kadin Hastaliklari ve Dogum Anabilim Dali Tup Bebek Unitesi'nde yurutulen prospektif randomize bir calismadir. ICSI uygulanan toplam 91 PCOS hastasi, bir GnRH antagonist protokolu ile r-FSH (n = 46) ve HP-uFSH (n = 45) almak uzere rastgele belirlendi. Ana sonuc olcutleri; alinan olgun oosit sayisi, embriyo kalitesi, gebelik oranlari, implantasyon oranlariydi. Bulgular: Alinan olgun oosit sayisi, dollenme oranlari, dondurularak saklanan embriyo sayisi r-FSH grubunda anlamli olarak daha yuksek (sirasiyla p = 0,024, p = 0,023, p = 0,026), ayni grupta kullanilan toplam FSH dozu ise anlamli olarak daha dusuktu (p = 0,023). Gebelik oranlari, klinik gebelik oranlari r-FSH grubunda istatistiksel olarak anlamli olmamakla birlikte daha yuksekti (sirasiyla %52,2'ye karsi %35,6, p = 0,11, %37'ye karsi %28,9, p = 0,41). Klinik gebelik basina genel tedavi maliyetleri, r-FSH grubunda %9,94'luk bir artisla iliskilendirilirken, gebelik basina maliyetler gruplar arasinda farkli degildi. Sonuc: r-FSH, PCOS'de fertilizasyon oranlari, alinan olgun oosit sayisi ve dondurularak saklanan embriyolar, gebelik oranlari acisindan HP-uFSH'den ustundur, ancak klinik gebelik basina genel tedavi maliyetleri daha yuksektir. Anahtar kelimeler: ART, HP-uFSH, PCOS, rec-FSH