InfertilityPhase 4NCT00461916
Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin
A Phase 4 study testing Half-Dose Depot Triptorelin and Reduced-Dose Daily Buserelin in people with Infertility, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Half-Dose Depot Triptorelin and Reduced-Dose Daily Buserelin
- How many people
- 182 participants
- Where
- 1 siteIran
- Study dates
- May 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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]
Show all 11Show fewer
- No known history or risk of severe hyperstimulation
- No evidence of hydrosalpinx
- No major systemic disease
- No uterine abnormality
- No previous ovarian surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET
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
Read the 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.
- Conditions
- Infertility
- Being tested
- Half-Dose Depot Triptorelin, Reduced-Dose Daily Buserelin
- Keywords
- half-dose depot triptorelin, reduced-dose daily buserelin, controlled ovarian stimulation, long protocol, ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half-Dose Depot TriptorelinDrug
Reduced-Dose Daily BuserelinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocytes
Secondary outcomes (14)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMay 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 182 participants
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Leili Safdarian, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461916
- Sponsor's protocol ID
- 5152
- Status last verified
- Apr 2007
- First submitted
- 17 Apr 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17635844
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET
- ClinicalTrials.gov ID
- NCT00461916
- Acronym / sponsor ID
- 5152
- Conditions
- Infertility
- Keywords
- half-dose depot triptorelin, reduced-dose daily buserelin, controlled ovarian stimulation, long protocol, ICSI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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]
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Half-Dose Depot Triptorelin | Drug | – |
| Reduced-Dose Daily Buserelin | Drug | – |
Primary outcome
Number of retrieved oocytes
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
- Derived from this study: PubMed 17635844Safdarian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leili Safdarian, MD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Half-Dose Depot Triptorelin and Reduced-Dose Daily Buserelin in people with Infertility, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved oocytes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.