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Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Half-Dose Depot Triptorelin
Reduced-Dose Daily Buserelin
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring half-dose depot triptorelin, reduced-dose daily buserelin, controlled ovarian stimulation, long protocol, ICSI

Eligibility Criteria

undefined - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Shariati Hospital

Outcomes

Primary Outcome Measures

Number of retrieved oocytes

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2007
Last Updated
April 17, 2007
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00461916
Brief Title
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

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
half-dose depot triptorelin, reduced-dose daily buserelin, controlled ovarian stimulation, long protocol, ICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
182 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Half-Dose Depot Triptorelin
Intervention Type
Drug
Intervention Name(s)
Reduced-Dose Daily Buserelin
Primary Outcome Measure Information:
Title
Number of retrieved oocytes
Secondary Outcome Measure Information:
Title
Number of days of gonadotropin stimulation
Title
Number of hMG ampoules
Title
Number of follicles at hCG administration
Title
Quality of oocytes
Title
Quality of embryos
Title
Poor response rate
Title
Oocyte fertilization rate
Title
Ineffective intervention rate
Title
Clinical pregnancy rate
Title
Implantation rate
Title
Biochemical pregnancy rate
Title
Multiple pregnancy rate
Title
Miscarriage rate
Title
Ectopic pregnancy rate

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leili Safdarian, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Shariati Hospital
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17635844
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.
Results Reference
derived

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Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

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