Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Half-Dose Depot Triptorelin Drug: Reduced-Dose Daily Buserelin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET |
- Number of retrieved oocytes
- 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
| Estimated Enrollment: | 182 |
| Study Start Date: | May 2005 |
| Study Completion Date: | December 2006 |
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| Ages Eligible for Study: | up to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Iran, Islamic Republic of | |
| Dr. Shariati Hospital | |
| Tehran, Iran, Islamic Republic of, 14114 | |
| Principal Investigator: | Leili Safdarian, MD | Tehran University of Medical Sciences |
More Information
No publications provided by Tehran University of Medical Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00461916 History of Changes |
| Other Study ID Numbers: | 5152 |
| Study First Received: | April 17, 2007 |
| Last Updated: | April 17, 2007 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Tehran University of Medical Sciences:
|
half-dose depot triptorelin reduced-dose daily buserelin controlled ovarian stimulation long protocol ICSI |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Buserelin Triptorelin Fertility Agents, Female Fertility Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013