Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461916
• Other study ID #: 5152
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2007
• Last updated: April 17, 2007
• Start date: May 2005
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Half-Dose Depot Triptorelin

• Reduced-Dose Daily Buserelin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dr. Shariati Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of retrieved oocytes
Secondary	Number of days of gonadotropin stimulation
Secondary	Number of hMG ampoules
Secondary	Number of follicles at hCG administration
Secondary	Quality of oocytes
Secondary	Quality of embryos
Secondary	Poor response rate
Secondary	Oocyte fertilization rate
Secondary	Ineffective intervention rate
Secondary	Clinical pregnancy rate
Secondary	Implantation rate
Secondary	Biochemical pregnancy rate
Secondary	Multiple pregnancy rate
Secondary	Miscarriage rate
Secondary	Ectopic pregnancy rate