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Completed

NCT Number: NCT00461916

Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

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

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Key information

Age range

Up to 35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Shariati Hospital

Tehran, Tehran Province, 14114, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Half-Dose Depot Triptorelin

Drug

Reduced-Dose Daily Buserelin

Drug

Primary outcomes

  1. Number of retrieved oocytes

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET

Important dates

Study start
2005
Study completion
2006
First posted
Apr 18, 2007
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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