Infertility Clinical Trial
Official title:
Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.
Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI
Status | Completed |
Enrollment | 151 |
Est. completion date | December 2005 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics: >/= 18 and < 40 years old BMI between 19 and 30 kg/m2 less than 3 previous completed cycles basal FSH level less than 10 IU/l within the 6 months prior to the study Exclusion Criteria: age < 18 and >/= 40 years primary ovarian failure or women known as poor responders, i.e. requiring more than 225 IU of FSH as starting dose in previous treatment cycles or having less than 3 oocytes retrieved or with an oestradiol serum concentration < 900 pmol/l (250 pg/ml) ovarian cysts > 20 mm oocyte donation thawed embryos replacement patients affected by pathologies associated with any contraindication of being pregnant ascertained or presumptive hypersensitivity to the active principle and/or their ingredients abnormal bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias severe impairment of the renal and/or hepatic functions women deprived of their freedom by administrative or legal decision |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Private Consulting | Bron | |
France | Hôpital Jeanne de Flandre | Lille | |
France | Hôpital Edouard Herriot | Lyon | |
France | Institut de Médecine de la Reproduction | Marseille | |
France | Hôpital Américain | Neuilly sur Seine | |
France | Hôpital Tenon | Paris | |
Hungary | Semmelweis Medical School | Budapest |
Lead Sponsor | Collaborator |
---|---|
IBSA Institut Biochimique SA |
France, Hungary,
Daya S, Gunby J. Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction. Hum Reprod. 1999 Sep;14(9):2207-15. — View Citation
Doré PC, Rice C, Killick S. Human gonadotrophin preparations. May cause allergic reaction. BMJ. 1994 Jun 4;308(6942):1509. — View Citation
Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. Review. — View Citation
GEMZELL CA, DICZFALUSY E, TILLINGER G. Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958 Dec;18(12):1333-48. — View Citation
Hackelöer BJ, Fleming R, Robinson HP, Adam AH, Coutts JR. Correlation of ultrasonic and endocrinologic assessment of human follicular development. Am J Obstet Gynecol. 1979 Sep 1;135(1):122-8. — View Citation
Howles CM, Loumaye E, Giroud D, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study. Hum Reprod. 1994 Mar;9(3):424-30. — View Citation
Mendelson EB, Bohm-Velez M, Joseph N, Neiman HL. Gynecologic imaging: comparison of transabdominal and transvaginal sonography. Radiology. 1988 Feb;166(2):321-4. — View Citation
Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9. — View Citation
Oelsner G, Serr DM, Mashiach S, Blankstein J, Snyder M, Lunenfeld B. The study of induction of ovulation with menotropins: analysis of results of 1897 treatment cycles. Fertil Steril. 1978 Nov;30(5):538-44. — View Citation
Remorgida V, Venturini PL, Anserini P, Lanera P, De Cecco L. Administration of pure follicle-stimulating hormone during gonadotropin-releasing hormone agonist therapy in patients with clomiphene-resistant polycystic ovarian disease: hormonal evaluations and clinical perspectives. Am J Obstet Gynecol. 1989 Jan;160(1):108-13. — View Citation
Schwartz M, Jewelewicz R, Dyrenfurth I, Tropper P, Vande Wiele RL. The use of human menopausal and chorionic gonadotropins for induction of ovulation. Sixteen years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol. 1980 Dec 1;138(7 Pt 1):801-7. — View Citation
Thompson CR, Hansen LM. Pergonal (menotropins): a summary of clinical experience in the induction of ovulation and pregnancy. Fertil Steril. 1970 Dec;21(12):844-53. — View Citation
Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11. — View Citation
Wang CF, Gemzell C. The use of human gonadotropins for the induction of ovulation in women with polycystic ovarian disease. Fertil Steril. 1980 May;33(5):479-86. — View Citation
Wikland M, Borg J, Hamberger L, Svalander P. Simplification of IVF: minimal monitoring and the use of subcutaneous highly purified FSH administration for ovulation induction. Hum Reprod. 1994 Aug;9(8):1430-6. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Oocytes Retrieved | Total number of oocytes retrieved | 10 days after stimulation start | No |
Secondary | Clinical Pregnancy Rate | clinical pregnancy rate defined as the presence of gestation sac and heart beat. | 6 weeks after treatment start | No |
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