Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-12-31

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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Half-Dose Depot Triptorelin

Intervention Type DRUG

Reduced-Dose Daily Buserelin

Intervention Type DRUG

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

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Leili Safdarian, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Dr. Shariati Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED

PMID: 17635844 (View on PubMed)

Other Identifiers

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5152

Identifier Type: -

Identifier Source: org_study_id