InfertilityPhase 4NCT00461422
Early Follicular Supplementation of Ganirelix in IVF 2004
A Phase 4 study testing Ganirelix in people with Infertility and IVF Treatment, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, IVF Treatment
- What is being tested?
- Ganirelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2004to Jun 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- infertility
- IVF candidate
- failure of previous IVF attempt
Who cannot join
- low ovarian reserve
- untreated distortion of uterine cavity
- medical contraindication for IVF treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results
Read the detailed description
GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol.
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results.
Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.
- Conditions
- Infertility, IVF Treatment
- Being tested
- Ganirelix
- Keywords
- IVF, GnRH antagonist
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanirelixDrug
sc injection of Ganirelix 0.25 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle Receives: Drug: Ganirelix |
| 2 | No intervention | Standard Flexible antagonist protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates
Measured: one cycle
Secondary outcomes (5)
differences in hormonal levels
Measured: one cycle
differences in the basic treatment doses
Measured: one cycle
oocyte counts
Measured: one cycle
fertilization rate
Measured: one cycle
cleavage rate
Measured: one cycle
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 startJan 2004
- Primary completionJun 2007
- Study completionJun 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Collaborators
- Organon
- Investigators
- Yohnny S Younis, MD, Principal investigator, The Ministry of Health, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461422
- Sponsor's protocol ID
- soltsman2004.CTIL
- Status last verified
- Jun 2008
- First submitted
- 17 Apr 2007
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles
- ClinicalTrials.gov ID
- NCT00461422
- Acronym / sponsor ID
- soltsman2004.CTIL
- Conditions
- Infertility, IVF Treatment
- Keywords
- IVF, GnRH antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Collaborators
- Organon
- Study start
- Jan 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (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.
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results
Detailed description
GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol.
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results.
Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GanirelixStandard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle |
| 2 | No intervention | –Standard Flexible antagonist protocol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- infertility
- IVF candidate
- failure of previous IVF attempt
Key exclusion criteria (3 listed)
- low ovarian reserve
- untreated distortion of uterine cavity
- medical contraindication for IVF treatment
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 |
|---|---|---|
| Ganirelixsc injection of Ganirelix 0.25 mg per day | Drug | 1 |
Primary outcome
pregnancy rates
Time frame: one cycle
5 secondary outcomes
differences in hormonal levels
Time frame: one cycle
differences in the basic treatment doses
Time frame: one cycle
oocyte counts
Time frame: one cycle
fertilization rate
Time frame: one cycle
cleavage rate
Time frame: one cycle
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 27 Jun 2008.
Related trials for Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Yohnny S Younis, MD principal investigator
The Ministry of Health, Israel
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 Ganirelix in people with Infertility and IVF Treatment, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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 3 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 27 Jun 2008. 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 Israel. 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?
pregnancy rates (time frame: one cycle). 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 27 Jun 2008; AzTrials last refreshed its copy on 8 Nov 2026.