Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.

NCT00335725 | Completed Phase 3 Results

• 1 other identifier: 01GBF/FSH08
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Infertility

Keywords

Ovarian stimulation; Infertility; ICSI; FSH

Outcome Measures

Primary Outcomes (1)

• Total Number of Oocytes Retrieved

  Total number of oocytes retrieved

  10 days after stimulation start

Secondary Outcomes (1)

• Clinical Pregnancy Rate

  6 weeks after treatment start

Study Arms (2)

Fostimon

EXPERIMENTAL

Fostimon is an highly purified FSH preparation.

Drug: Follicle Stimulating Hormone

Gonal-F

ACTIVE COMPARATOR

Gonal-F is a recombinant FSH preparation.

Drug: Follicle Stimulating Hormone

Interventions

Follicle Stimulating Hormone DRUG

subcutaneous injection of FSH. Starting dose: 225 IU.

Also known as: highly purified human derived FSH; Fostimon

Fostimon

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (7)

Private Consulting

Bron, France

Location

Hôpital Jeanne de Flandre

Lille, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Institut de Médecine de la Reproduction

Marseille, France

Location

Hôpital Américain

Neuilly-sur-Seine, France

Location

Hôpital Tenon

Paris, France

Location

Semmelweis Medical School

Budapest, Hungary

Location

Related Publications (15)

• 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. doi: 10.1210/jcem-18-12-1333. No abstract available.

  PMID: 13611018 BACKGROUND

• 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. doi: 10.1016/s0015-0282(16)37925-0. No abstract available.

  PMID: 5481991 BACKGROUND

• 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. doi: 10.1016/s0015-0282(16)43634-4. No abstract available.

  PMID: 720642 BACKGROUND

• 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. doi: 10.1016/s0002-9378(16)32740-5.

  PMID: 6778212 BACKGROUND

• Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9.

  PMID: 622235 BACKGROUND

• Dore PC, Rice C, Killick S. Human gonadotrophin preparations. May cause allergic reaction. BMJ. 1994 Jun 4;308(6942):1509. doi: 10.1136/bmj.308.6942.1509b. No abstract available.

  PMID: 8019294 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.humrep.a138522.

  PMID: 8006130 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.humrep.a138724.

  PMID: 7989500 BACKGROUND

• Daya S, Gunby J. Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction. Hum Reprod. 1999 Sep;14(9):2207-15. doi: 10.1093/humrep/14.9.2207.

  PMID: 10469682 BACKGROUND

• 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. doi: 10.1016/0002-9378(89)90099-9.

  PMID: 2492145 BACKGROUND

• Hackeloer 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.

  PMID: 474642 BACKGROUND

• 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.

  PMID: 6419189 BACKGROUND

• Mendelson EB, Bohm-Velez M, Joseph N, Neiman HL. Gynecologic imaging: comparison of transabdominal and transvaginal sonography. Radiology. 1988 Feb;166(2):321-4. doi: 10.1148/radiology.166.2.3275976.

  PMID: 3275976 BACKGROUND

• Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. doi: 10.1097/00003081-199106000-00027.

  PMID: 1868645 BACKGROUND

• 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. doi: 10.1016/s0015-0282(16)44711-4.

  PMID: 6768596 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Follicle Stimulating Hormone; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: IBSA Clinical Research Manager
• Organization: IBSA instutut Biochimique SA

sd@ibsa.ch

+41 58 360 1000

Study Officials

• J G Grudzinskas, Prof

  The Bridge Centre One St Thomas Street London Bridge London SE1 9RY, UK2.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2006
• First Posted: June 12, 2006
• Study Start: March 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: March 27, 2015
• Results First Posted: March 27, 2015

Record last verified: 2015-03

Locations

FR (6); HU (1)