ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant hCG in Women Undergoing IVF

This study is currently recruiting participants.
Verified by IBSA Institut Biochimique SA, May 2007

Sponsored by: IBSA Institut Biochimique SA
Information provided by: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00335569
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: hCG-IBSA
Phase III

MedlinePlus related topics:   Infertility   

ChemIDplus related topics:   Chorionic gonadotropin    Choriogonadotropin Alfa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerance and Clinical Equivalence of hCG- IBSA (IBSA) Versus Ovitrelle (Serono), Both Administered Sub-Cutaneously in Women Undergoing in Vitro Fertilization (IVF).

Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Total number of oocytes retrieved per patient who received hCG

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   144
Study Start Date:   August 2005

Detailed Description:

This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.

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

Criteria

Inclusion Criteria:

  • >/=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.

Exclusion Criteria:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335569

Locations
Switzerland
Department of Gynecology and ObstetricsUniversity Hospital     Recruiting
      Geneve, Switzerland, 1211
      Contact: Dominique de Ziegler, Prof.     022.382.45.68 ext +41        
      Contact: Suzanne Duperret, Secrétariat     022.382.46.06 ext +41        
      Principal Investigator: Dominique de Ziegler, Prof.            
Department of Gynecology and Obstetrics Universitätfrauenklinik     Recruiting
      Basel, Switzerland, 4031
      Contact: Christian De Geyter, Prof.     (61) 265 93 15 ext +41        
      Principal Investigator: Christian de Geyter, Prof.            
4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102     Recruiting
      Bern, Switzerland, 3010
      Contact: Martin Birkhäuser, prof.     031 632 13 10 ext +41        
      Principal Investigator: Martin Birkhäuser, Prof.            
3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois     Recruiting
      Lausanne, Switzerland, 1011
      Contact: Dominique De Ziegler, Prof.     (021) 314 32 88 ext +41        
      Principal Investigator: Dominique De Ziegler, Prof.            

Sponsors and Collaborators
IBSA Institut Biochimique SA

Investigators
Principal Investigator:     Dominique de Ziegler, Prof.     Départements de Gynécologie/Obstétrique et de Pédiatrie    
  More Information


Publications:
Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem. 1981;50:465-95. Review. No abstract available.
 
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. No abstract available.
 
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.
 
GEMZELL C. INDUCTION OF OVULATION WITH HUMAN GONADOTROPINS. Recent Prog Horm Res. 1965;21:179-204. Review. No abstract available.
 
Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. Review.
 
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.
 
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. 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.
 
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.
 
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. No abstract available.
 
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.
 

Study ID Numbers:   04CH/HCG02
First Received:   June 9, 2006
Last Updated:   May 29, 2007
ClinicalTrials.gov Identifier:   NCT00335569
Health Authority:   Switzerland: Swissmedic

Keywords provided by IBSA Institut Biochimique SA:
Infertility, sterility, hCG, IVF  

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Chorionic Gonadotropin
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 14, 2008




Links to all studies - primarily for crawlers