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

Infertility Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335894
• Other study ID #: 04I/HMG10
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2006
• Last updated: March 9, 2010
• Start date: May 2005
• Est. completion date: March 2009

Study information

• Verified date: December 2008
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• hMG-IBSA

Locations

Country	Name	City	State
Italy	Università degli Studi di Bologna	Bologna
Italy	Università degli Studi di Napoli Federico II	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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. — View Citation

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. — 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

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. Review. — View Citation

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. — View Citation

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. — 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

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

Veeck LL. Oocyte assessment and biological performance. Ann N Y Acad Sci. 1988;541:259-74. — 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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total number of oocytes retrieved 34 - 36 hours after hCG administration.
Secondary	Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17ß-estradiol (E2) serum concentration; number of follicles >16 mm.
Secondary	number of mature oocytes and inseminated oocytes; fertilization rate.
Secondary	embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
Secondary	Tolerability evaluation