InfertilityPhase 3NCT00823602
Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH
A Phase 3 study testing ganirelix and suprefact in people with Infertility, run by Yazd Research & Clinical Center for Infertility at 1 site in Iran.
Trial summary
Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- ganirelix and suprefact
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIran
- Study dates
- Mar 2008to Jan 2009
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- first cycle of ART
- age < 35 years
- basal FSH < 10 IU/L
Who cannot join
- previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis
- only one ovary
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Yazd Research and Clinical Center For Infertility
Yazd, Yazd Province
razieh firouzabadi, MD, 8247085 ext. +98351, dr_firouzabadi@yahoo.com
shahnaz Ahmadi, MD, 9173717981 ext. +98, AHMADISHAHNAZ2005@yahoo.com
About this study
Official title: Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART
Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique.
This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART.
The investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .
- Conditions
- Infertility
- Being tested
- ganirelix, suprefact
- Keywords
- GnRH antagonist, GnRH agonist, pregnancy rate, Ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganirelixDrug
These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).
suprefactDrug
GnRH agonist, standard protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation Receives: Drug: ganirelix |
| 2 | Active comparator | GnRH agonist, suprefact, stimulation with a standard long protocol Receives: Drug: suprefact |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: 2weeks
Secondary outcomes (1)
ovarian stimulation
Measured: 10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yazd Research & Clinical Center for Infertility
- Sponsor type
- University, hospital or other
- Investigators
- razieh firouzabadi, MD, Study chair, Yazd Research & Clinical Center for Infertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823602
- Sponsor's protocol ID
- 1387YAZDRCCI
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 15 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART
- ClinicalTrials.gov ID
- NCT00823602
- Acronym / sponsor ID
- 1387YAZDRCCI
- Conditions
- Infertility
- Keywords
- GnRH antagonist, GnRH agonist, pregnancy rate, Ovarian stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Yazd Research & Clinical Center for InfertilityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (estimated)
- First posted
- 15 Jan 2009 (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.
Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique.
This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART.
The investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ganirelixGnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation |
| 2 | Active comparator | Drug: suprefactGnRH agonist, suprefact, stimulation with a standard long protocol |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- first cycle of ART
- age < 35 years
- basal FSH < 10 IU/L
Key exclusion criteria (2 listed)
- previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis
- only one ovary
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 |
|---|---|---|
| ganirelixThese patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ). | Drug | 1 |
| suprefactGnRH agonist, standard protocol | Drug | 2 |
Primary outcome
pregnancy rate
Time frame: 2weeks
1 secondary outcome
ovarian stimulation
Time frame: 10days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2009.
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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.
razieh firouzabadi, MD study chair
Yazd Research & Clinical Center for Infertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ganirelix and suprefact in people with Infertility, run by Yazd Research & Clinical Center for Infertility 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jan 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact razieh firouzabadi, MD (8247085 ext. +98351, dr_firouzabadi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 2weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2009.