Back to resultsEfficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Follicle Stimulating Hormone
Follicle Stimulating Hormone
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Ovarian stimulation, Infertility, ICSI, FSH
Eligibility 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
Sites / Locations
- Private Consulting
- Hôpital Jeanne de Flandre
- Hôpital Edouard Herriot
- Institut de Médecine de la Reproduction
- Hôpital Américain
- Hôpital Tenon
- Semmelweis Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fostimon
Gonal-F
Arm Description
Fostimon is an highly purified FSH preparation.
Gonal-F is a recombinant FSH preparation.
Outcomes
Primary Outcome Measures
Total Number of Oocytes Retrieved
Total number of oocytes retrieved
Secondary Outcome Measures
Clinical Pregnancy Rate
clinical pregnancy rate defined as the presence of gestation sac and heart beat.
Full Information
NCT ID
NCT00335725
First Posted
June 9, 2006
Last Updated
March 23, 2015
Sponsor
IBSA Institut Biochimique SA
1. Study Identification
Unique Protocol Identification Number
NCT00335725
Brief Title
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IBSA Institut Biochimique SA
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Ovarian stimulation, Infertility, ICSI, FSH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fostimon
Arm Type
Experimental
Arm Description
Fostimon is an highly purified FSH preparation.
Arm Title
Gonal-F
Arm Type
Active Comparator
Arm Description
Gonal-F is a recombinant FSH preparation.
Intervention Type
Drug
Intervention Name(s)
Follicle Stimulating Hormone
Other Intervention Name(s)
highly purified human derived FSH; Fostimon
Intervention Description
subcutaneous injection of FSH. Starting dose: 225 IU.
Intervention Type
Drug
Intervention Name(s)
Follicle Stimulating Hormone
Other Intervention Name(s)
rec FSH; Gonal F
Intervention Description
subcutaneous injection of FSH. Starting dose: 225 IU.
Primary Outcome Measure Information:
Title
Total Number of Oocytes Retrieved
Description
Total number of oocytes retrieved
Time Frame
10 days after stimulation start
Secondary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
clinical pregnancy rate defined as the presence of gestation sac and heart beat.
Time Frame
6 weeks after treatment start
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J G Grudzinskas, Prof
Organizational Affiliation
The Bridge Centre One St Thomas Street London Bridge London SE1 9RY, UK2.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Consulting
City
Bron
Country
France
Facility Name
Hôpital Jeanne de Flandre
City
Lille
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Institut de Médecine de la Reproduction
City
Marseille
Country
France
Facility Name
Hôpital Américain
City
Neuilly sur Seine
Country
France
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Name
Semmelweis Medical School
City
Budapest
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
13611018
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. doi: 10.1210/jcem-18-12-1333. No abstract available.
Results Reference
background
PubMed Identifier
5481991
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. doi: 10.1016/s0015-0282(16)37925-0. No abstract available.
Results Reference
background
PubMed Identifier
720642
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. doi: 10.1016/s0015-0282(16)43634-4. No abstract available.
Results Reference
background
PubMed Identifier
6778212
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. doi: 10.1016/s0002-9378(16)32740-5.
Results Reference
background
PubMed Identifier
622235
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.
Results Reference
background
PubMed Identifier
8019294
Citation
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.
Results Reference
background
PubMed Identifier
8006130
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. doi: 10.1093/oxfordjournals.humrep.a138522.
Results Reference
background
PubMed Identifier
7989500
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. doi: 10.1093/oxfordjournals.humrep.a138724.
Results Reference
background
PubMed Identifier
10469682
Citation
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.
Results Reference
background
PubMed Identifier
2492145
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. doi: 10.1016/0002-9378(89)90099-9.
Results Reference
background
PubMed Identifier
474642
Citation
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.
Results Reference
background
PubMed Identifier
6419189
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.
Results Reference
background
PubMed Identifier
3275976
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. doi: 10.1148/radiology.166.2.3275976.
Results Reference
background
PubMed Identifier
1868645
Citation
Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. doi: 10.1097/00003081-199106000-00027.
Results Reference
background
PubMed Identifier
6768596
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. doi: 10.1016/s0015-0282(16)44711-4.
Results Reference
background
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Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
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