Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

• ClinicalTrials.gov Identifier: NCT00335894
• Recruitment Status: Completed
• First Posted: June 12, 2006
• Last Update Posted: March 10, 2010
• Sponsor: IBSA Institut Biochimique SA
• Information provided by: IBSA Institut Biochimique SA

Tracking Information

• First Submitted Date: June 9, 2006
• First Posted Date: June 12, 2006
• Last Update Posted Date: March 10, 2010
• Study Start Date: May 2005
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 9, 2006): total number of oocytes retrieved 34 - 36 hours after hCG administration.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 9, 2006)

• Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.
• number of mature oocytes and inseminated oocytes; fertilization rate.
• embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
• Tolerability evaluation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).
• Official Title: A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)
• Brief Summary: Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).
• Detailed Description: The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment
• Condition: Infertility
• Intervention: Drug: hMG-IBSA
• Study Arms: Not Provided

Publications *

• Hauschke D, Kieser M, Diletti E, Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stat Med. 1999 Jan 15;18(1):93-105. doi: 10.1002/(sici)1097-0258(19990115)18:13.0.co;2-8.
• Veeck LL. Oocyte assessment and biological performance. Ann N Y Acad Sci. 1988;541:259-74. doi: 10.1111/j.1749-6632.1988.tb22263.x. No abstract available.
• 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.
• Filicori M, Cognigni GE, Pocognoli P, Tabarelli C, Ferlini F, Perri T, Parmegiani L. Comparison of controlled ovarian stimulation with human menopausal gonadotropin or recombinant follicle-stimulating hormone. Fertil Steril. 2003 Aug;80(2):390-7. doi: 10.1016/s0015-0282(03)00594-6.
• Kilani Z, Dakkak A, Ghunaim S, Cognigni GE, Tabarelli C, Parmegiani L, Filicori M. A prospective, randomized, controlled trial comparing highly purified hMG with recombinant FSH in women undergoing ICSI: ovarian response and clinical outcomes. Hum Reprod. 2003 Jun;18(6):1194-9. doi: 10.1093/humrep/deg252.
• 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.
• 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.
• 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.
• Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9.
• 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.
• Vermesh M, Kletzky OA. Follicle-stimulating hormone is the main determinant of follicular recruitment and development in ovulation induction with human menopausal gonadotropin. Am J Obstet Gynecol. 1987 Dec;157(6):1397-402. doi: 10.1016/s0002-9378(87)80231-4.
• Brown JB, Evans JH, Adey FD, Taft HP, Townsend L. Factors involved in the induction of fertile ovulation with human gonadotrophins. J Obstet Gynaecol Br Commonw. 1969 Apr;76(4):289-307. doi: 10.1111/j.1471-0528.1969.tb05837.x. No abstract available.
• 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.
• Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv. 1989 Jun;44(6):430-40. doi: 10.1097/00006254-198906000-00004. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 9, 2006): 144
• Original Enrollment: Same as current
• Study Completion Date: March 2009
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
• Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
• > 18/= and < 37 years old;
• BMI between 18 and 28 kg/m2;
• Less than 3 previous completed IVF cycles;
• Basal FSH level less than 10 IU/L once within 6 months prior to the study;
• Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
• Normal or clinically insignificant haematology and blood chemistry values.

Exclusion Criteria:

• Primary ovarian failure or women known as poor responders;
• Signs of PCO, according to the Rotterdam Criteria;
• At least one ovary inaccessible for oocyte retrieval;
• One or more ovarian cysts > 10 mm;
• Hydrosalpinx that have not been surgically removed or ligated;
• Stage III or IV endometriosis;
• Patients affected by pathologies associated with any contraindication of being pregnant;
• Hypersensitivity to the study medication;
• Abnormal bleeding of undetermined origin;
• Uncontrolled thyroid or adrenal dysfunction;
• Neoplasias;
• PAP smear III within the last 2 years;
• Severe impairment of the renal and/or hepatic functions;
• Lactation;
• Hyperprolactinaemia;
• Participation in a concurrent clinical trial or in another trial within the past four weeks;
• Use of concomitant medication that might interfere with study evaluations.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 36 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00335894
• Other Study ID Numbers: 04I/HMG10
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: IBSA Institut Biochimique SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Giuseppe De Placido, Prof; Federico II University

• PRS Account: IBSA Institut Biochimique SA
• Verification Date: December 2008