InfertilityPhase 4NCT02048891
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
A Phase 4 study testing GnRH agonist trigger and hCG trigger in people with Infertility, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). Read more about this study
- Who is it for?
- Ages 35 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- GnRH agonist trigger and hCG trigger
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF patients with at least 4 consecutive failures.
- On trigger day, no more than 10 follicles of 12 mm and up
Who cannot join
- History of moderate or severe OHSS.
Trial locations and contacts
1 site in 1 country.
About this study
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.
The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.
- Conditions
- Infertility
- Being tested
- GnRH agonist trigger, hCG trigger
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonist triggerDrug
Also called Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
hCG triggerDrug
Also called Ovulation trigger with Ovitrelle 250 microgram., Luteal support with daily progesterone gel = Crinone 8%
| Study group | Role | What they receive |
|---|---|---|
| hCG trigger | Active comparator | Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. Receives: Drug: hCG trigger |
| GnRH agonist trigger | Experimental | ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. Receives: Drug: GnRH agonist trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Heart Activity 1 Month After Oocyte Retrieval
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Measured: 1 month after oocyte retrieval
Secondary outcomes (1)
Patients Comfort During the Luteal Phase
Measured: During 2 weeks from day of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Kol MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048891
- Sponsor's protocol ID
- RMB-0427-13
- Status last verified
- May 2015
- First submitted
- 27 Jan 2014
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
- ClinicalTrials.gov ID
- NCT02048891
- Acronym / sponsor ID
- RMB-0427-13
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.
The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hCG trigger | Active comparator | Drug: hCG triggerOvulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. |
| GnRH agonist trigger | Experimental | Drug: GnRH agonist triggerovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- IVF patients with at least 4 consecutive failures.
- On trigger day, no more than 10 follicles of 12 mm and up
Key exclusion criteria (1 listed)
- History of moderate or severe OHSS.
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 |
|---|---|---|
| GnRH agonist triggerAlso: Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. | Drug | GnRH agonist trigger |
| hCG triggerAlso: Ovulation trigger with Ovitrelle 250 microgram., Luteal support with daily progesterone gel = Crinone 8% | Drug | hCG trigger |
Primary outcome
Fetal Heart Activity 1 Month After Oocyte Retrieval
Time frame: 1 month after oocyte retrieval
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
1 secondary outcome
Patients Comfort During the Luteal Phase
Time frame: During 2 weeks from day of oocyte retrieval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GnRH agonist trigger and hCG trigger in people with Infertility, run by Rambam Health Care Campus 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 2 inclusion and 1 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 8 Jun 2015. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fetal Heart Activity 1 Month After Oocyte Retrieval (time frame: 1 month after oocyte retrieval). 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 8 Jun 2015.