Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin
Information source: Tehran University of Medical Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Half-Dose Depot Triptorelin (Drug); Reduced-Dose Daily Buserelin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s):
Leili Safdarian, MD, Principal Investigator, Affiliation: Tehran University of Medical Sciences
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
Clinical Details
Official title: Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Number of retrieved oocytes
Secondary outcome: Number of days of gonadotropin stimulationNumber 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
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.
Eligibility
Minimum age: N/A.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Dr. Shariati Hospital, Tehran 14114, Iran, Islamic Republic of
Additional Information
Starting date: May 2005
Ending date: December 2006
Last updated: April 17, 2007
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