Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00461916
First received: April 17, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

April 17, 2007
April 17, 2007
May 2005
Not Provided
Number of retrieved oocytes
Same as current
No Changes Posted
  • Number of days of gonadotropin stimulation
  • Number of hMG ampoules
  • Number of follicles at hCG administration
  • Quality of oocytes
  • Quality of embryos
  • Poor response rate
  • Oocyte fertilization rate
  • Ineffective intervention rate
  • Clinical pregnancy rate
  • Implantation rate
  • Biochemical pregnancy rate
  • Multiple pregnancy rate
  • Miscarriage rate
  • Ectopic pregnancy rate
Same as current
Not Provided
Not Provided
 
Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin
Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET

The purpose of this study is to determine whether half-dose depot triptorelin are as effective as reduced-dose daily buserelin in the controlled ovarian stimulation for intracytoplasmic sperm injection and embryo transfer

Significant doubts remain about which type of GnRH agonists [GnRHa] administration to be used in controlled ovarian stimulation [COS] cycles. The use of a single-dose depot long-acting GnRHa instead of a daily low dose preparation would be more comfortable for patients, however, inducing a profound pituitary desensitization, it increases the number of gonadotropin ampoules and the duration of the COS cycle without improving pregnancy rates or other clinical outcomes. Thus, some authors recommend a reduction of both dose and/or duration of GnRHa administration. Halving the dose of depot triptorelin, for instance, has been studied against its full dose administration since 1992 with rather similar clinical outcomes. Half-dose depot leuprolide acetate has also resulted in comparable clinical outcomes with standard daily injections in long GnRHa protocol. Reducing the daily doses of short acting GnRHa has been advocated to demonstrate equivalent results to standard doses. To our knowledge, however, the reduced daily doses have not been evaluated against half dose depot forms in long GnRHa protocols.

Thus, we originally compared a half-dose depot triptorelin with reduced daily doses of short-acting buserelin in a long protocol for intracytoplasmic sperm injection and embryo transfer [ICSI/ET] cycles.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Infertility
  • Drug: Half-Dose Depot Triptorelin
  • Drug: Reduced-Dose Daily Buserelin
Not Provided
Safdarian L, Mohammadi FS, Alleyassin A, Aghahosseini M, Meysamie A, Rahimi E. Clinical outcome with half-dose depot triptorelin is the same as reduced-dose daily buserelin in a long protocol of controlled ovarian stimulation for ICSI/embryo transfer: a randomized double-blind clinical trial (NCT00461916). Hum Reprod. 2007 Sep;22(9):2449-54. Epub 2007 Jul 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
December 2006
Not Provided

Inclusion Criteria:

  • Candidate for ICSI/ET
  • 35 years old or younger
  • Serum FSH less than 10 IU/l on day three of the previous menstrual cycle
  • No more than two previous IVF/ICSI attempts
  • No planned percutaneous epididymal sperm aspiration [PESA]
  • No planned testicular sperm extraction [TESE]
  • No known history or risk of severe hyperstimulation
  • No evidence of hydrosalpinx
  • No major systemic disease
  • No uterine abnormality
  • No previous ovarian surgery
Female
up to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00461916
5152
No
Not Provided
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Leili Safdarian, MD Tehran University of Medical Sciences
Tehran University of Medical Sciences
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP