Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Half-Dose Depot Triptorelin
* Drug: Reduced-Dose Daily Buserelin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Half-Dose Depot Triptorelin|nan|
|Drug: Reduced-Dose Daily Buserelin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of gonadotropin stimulation |  |  | 
| Number 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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half-dose depot triptorelin, reduced-dose daily buserelin, controlled ovarian stimulation, long protocol, ICSI