To consider of internal production of follitropin alfa or Cinnal-F drug which is similar to Gonal-F drug (which is produced by Ares Serono, Geneva, Switzerland ) in treatment of infertility patients, it is supposed that to evaluate this comparison make be helpful especially in the setting of expenditures.
Main objectives: Determination of implantation success rate in both group of Cinnal-F and Gonal-F subjects (ICSI/ET) Avicenna Infertility Clinic.
Determination of success pregnancy rate in both group of Cinnal-F and Gonal-F subjects (ICSI/ET) Avicenna Infertility Clinic.
Secondary objectives: Comparison of implantation success rate between both group of Cinnal-F and Gonal-F subjects (ICSI/ET) Avicenna Infertility Clinic.
Comparison of pregnancy rate between both group of Cinnal-F and Gonal-F subjects (ICSI/ET) Avicenna Infertility Clinic.
Success rate determination in both group (Cinnal-F and Gonal-F subjects (ICSI/ET) Avicenna Infertility Clinic) with differentiation of age, BMI, duration of drug stimulation, estradiol level on HCG prescription day, MII oocyte number, embryo number,...
This prospective randomized clinical trial were conducted in infertility subjects of Avicenna Infertility Clinic with main reason of male factor. They were divided randomly in two group included 42 subjects in every group. All participants gave written consent prior to enrollment in the program project, according to the principles of the ethics committee of Avicenna Research Institute. Inclusion criteria include: FSH(Follicular Stimulating Hormon)≤ 10, normal blood prolactin, no pathology in uterus and adnexa, regular menses (25-35 days), with no history of more than three times ICSI cycles, with various types of infertility causes includes: PCOD, tubal factor, male factor, unexplained infertility, PGD, mild and moderate endometriosis. Exclusion criteria were: systemic diseases, BMI (Body Mass Index) ˃30, history of severe OHSS (Ovarian Hyper Stimulation Syndrome), history of poor respond in previous cycles, history of any pathology in uterus and adnexa. All patients underwent the protocol of long ICSI cycles treatment. After suppression of ovaries,patients received 150IU/d SC Cinnal-F or Gonal-F randomly for 5days from third day of menses after confirming of effective pituitary down regulation; it had been accomplished by no follicles 10 mm in diameter by vaginal sonography.Human chorionic gonadotropin(hCG) 5000-1000IU IM (IBSA)was administered 34-36 hours before oocyte retrieval to stimulate the final stages of follicular development by assistance of vaginal ultra-sonography when we inspected at least two follicles measure 17-18 mm in mean diameter and others routinly14-16 mm. After oocyte retrieval, we determined the number and maturity of oocytes (MII, MI, G.V.) and furthermore, specified the fertilization rate, the number and quality of the embryos on the following days. Clinical pregnancy and fetal sac at 6 weeks of pregnancy was validated by measurement of β-hCG and repeat after 48 hours and vaginal ultra-sonography respectively.