Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00461916
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
Information provided by:
Tehran University of Medical Sciences

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infertility Drug: Half-Dose Depot Triptorelin Drug: Reduced-Dose Daily Buserelin Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET
Study Start Date : May 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of retrieved oocytes

Secondary Outcome Measures :
  1. Number of days of gonadotropin stimulation
  2. Number of hMG ampoules
  3. Number of follicles at hCG administration
  4. Quality of oocytes
  5. Quality of embryos
  6. Poor response rate
  7. Oocyte fertilization rate
  8. Ineffective intervention rate
  9. Clinical pregnancy rate
  10. Implantation rate
  11. Biochemical pregnancy rate
  12. Multiple pregnancy rate
  13. Miscarriage rate
  14. Ectopic pregnancy rate

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00461916

Iran, Islamic Republic of
Dr. Shariati Hospital
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Principal Investigator: Leili Safdarian, MD Tehran University of Medical Sciences

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00461916     History of Changes
Other Study ID Numbers: 5152
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by Tehran University of Medical Sciences:
half-dose depot triptorelin
reduced-dose daily buserelin
controlled ovarian stimulation
long protocol

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents