Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI. - Full Text View

Purpose

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

Condition	Intervention	Phase
Infertility	Drug: FSH (Fostimon - IBSA) Drug: Gonal-F®, Serono	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:

Total number of oocytes retrieved

Secondary Outcome Measures:

total dose of FSH (IU);number of days of FSH stimulation and duration of stimulation;cancellation rate; oestradiol serum concentration on the day of hCG injection; number of follicles >14 mm on the day of hCG injection.Fertilization rate (Day 1; cleavage

Estimated Enrollment:	150
Study Start Date:	March 2003

Detailed Description:

This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria.

In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: “You are required not to inform the Investigator about the product’s name”.

The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients’ recruitment and of decreasing the biases related to attitudes in a specific centre.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335725

Locations

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, France
Hungary
Semmelweis Medical School
Budapest, Hungary

Sponsors and Collaborators

IBSA Institut Biochimique SA

Investigators

Principal Investigator:

J G Grudzinskas, Prof

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

More Information

Publications:

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. No abstract available.

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. No abstract available.

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. No abstract available.

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.

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

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

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.

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.

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

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.

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.

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.

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

Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. Review.

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.

ClinicalTrials.gov Identifier:	NCT00335725 History of Changes
Other Study ID Numbers:	01GBF/FSH08
Study First Received:	June 9, 2006
Last Updated:	May 29, 2007
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by IBSA Institut Biochimique SA:

Ovarian stimulation
Infertility
ICSI
FSH

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 16, 2012