Clinical trial NCT00461916: Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin
Official title: Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: half-dose depot triptorelin
reduced-dose daily buserelin
controlled ovarian stimulation
long protocol
ICSI
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 182
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Number of retrieved oocytes
Secondary outcomes:
measure: Number of days of gonadotropin stimulation
measure: Number of hMG ampoules
measure: Number of follicles at hCG administration
measure: Quality of oocytes
measure: Quality of embryos
measure: Poor response rate
measure: Oocyte fertilization rate
measure: Ineffective intervention rate
measure: Clinical pregnancy rate
measure: Implantation rate
measure: Biochemical pregnancy rate
measure: Multiple pregnancy rate
measure: Miscarriage rate
measure: Ectopic pregnancy rate
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dr. Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Leili Safdarian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/humrep/dem223. Epub 2007 Jul 17.