Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation

NCT00335569 | Completed Phase 3

• 1 other identifier: 04CH/HCG02
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing IVF.

Conditions

Infertility

Keywords

Infertility, sterility, hCG, IVF

Outcome Measures

Primary Outcomes (1)

• Total number of oocytes retrieved per patient who received hCG

Secondary Outcomes (5)

• Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,

• 2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;

• Implantation rate;Pregnancy rate.

• Adverse Events

  from day 1 to 35 +/- 7 days after oocytes retrieval

• Incidence of moderate or severe OHSS

  From the day of hCG injection until 35 +/- 7 days after oocyte retrieval

Interventions

hCG-IBSA DRUG

Eligibility Criteria

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

You may qualify if:

• \>/=18 and \< 40 years old;
• BMI between 18 and 30 kg/m2;
• less than 3 previous completed cycles;
• both ovaries present;
• regular menstrual cycle of 25-35 days;
• infertility attributable to a tubal factor, American Fertility Society grade I or II endometriosis, male factor or unexplained factor.
• within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through hysterosalpingogram, sonohystrogram or hysteroscopic examination;
• basal FSH level less than 10 IU/L;
• criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16 mm or more, with acceptable serum E2 concentration).
• a male partner with semen analysis within the past 6 months showing acceptable values of seminal parameters, defined as \> 3x10 exp 6 spermatozoa/ml;
• qualified to receive 150 - 300 IU FSH as starting dose.

You may not qualify if:

• age \< 18 and \> o = 40 years;
• primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration \< 3'000 pmol/L);
• ovarian cysts \> 20 mm, or enlargement not due to polycystic ovarian syndrome;
• patients affected by pathologies associated with any contraindication of being pregnant;
• hypersensitivity to the study medication;
• any bleeding since stimulation;
• uncontrolled thyroid or adrenal dysfunction;
• neoplasias;
• severe impairment of the renal and/or hepatic functions;
• use of concomitant medication that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents);
• more than 18 days of FSH stimulation.

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (4)

Department of Gynecology and Obstetrics Universitätfrauenklinik

Basel, 4031, Switzerland

Location

4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102

Bern, 3010, Switzerland

Location

Department of Gynecology and ObstetricsUniversity Hospital

Geneva, 1211, Switzerland

Location

3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (12)

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  PMID: 6267989 BACKGROUND

• Johnsen SG. A study of human testicular function by the use of human menopausal gonadotrophin and of human chorionic gonadotrophin in male hypogonadotrophic eunuchoidism and infantilism. Acta Endocrinol (Copenh). 1966 Oct;53(2):315-41. doi: 10.1530/acta.0.0530315. No abstract available.

  PMID: 6012569 BACKGROUND

• Forest MG, David M, Lecoq A, Jeune M, Bertrans J. Kinetics of the HCG-induced steroidogenic response of the human testis. III. Studies in children of the plasma levels of testosterone and HCG: rationale for testicular stimulation test. Pediatr Res. 1980 Jun;14(6):819-24. doi: 10.1203/00006450-198006000-00009.

  PMID: 6105640 BACKGROUND

• GEMZELL C. INDUCTION OF OVULATION WITH HUMAN GONADOTROPINS. Recent Prog Horm Res. 1965;21:179-204. No abstract available.

  PMID: 14321057 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

• 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.

  PMID: 3122575 BACKGROUND

• 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.

  PMID: 5778792 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

• Abdalla HI, Ah-Moye M, Brinsden P, Howe DL, Okonofua F, Craft I. The effect of the dose of human chorionic gonadotropin and the type of gonadotropin stimulation on oocyte recovery rates in an in vitro fertilization program. Fertil Steril. 1987 Dec;48(6):958-63. doi: 10.1016/s0015-0282(16)59591-0.

  PMID: 3119376 BACKGROUND

• 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.

  PMID: 2660037 BACKGROUND

• 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.

  PMID: 9990695 BACKGROUND

• Bellavia M, de Geyter C, Streuli I, Ibecheole V, Birkhauser MH, Cometti BP, de Ziegler D. Randomized controlled trial comparing highly purified (HP-hCG) and recombinant hCG (r-hCG) for triggering ovulation in ART. Gynecol Endocrinol. 2013 Feb;29(2):93-7. doi: 10.3109/09513590.2012.730577. Epub 2012 Nov 2.

  PMID: 23116325 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Dominique de Ziegler, Prof.

  Départements de Gynécologie/Obstétrique et de Pédiatrie

  PRINCIPAL INVESTIGATOR

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: August 1, 2005
• Study Completion: December 1, 2008
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

CH (4)