InfertilityPhase 4NCT01607203
Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
A Phase 4 study testing Decapeptyl Daily and pregnyl in people with Infertility, run by AZ Jan Palfijn Gent at 1 site in Belgium.
Trial summary
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist. Read more about this study
- Who is it for?
- Ages Up to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Decapeptyl Daily and pregnyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Dec 2013
- 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 Up to 38 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
- 1,2 or 3 rd IVF-cycle
Who cannot join
- polycystic ovary syndrome (PCOS) patients
- patients with endocrinological diseases or problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.
- Conditions
- Infertility
- Being tested
- Decapeptyl Daily, pregnyl
- Keywords
- ovarian hyper stimulation syndrome (OHSS), metaphase II oocytes (MII), good quality embryo's, implantation, pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decapeptyl DailyDrug
Also called Gonapeptyl
Decapeptyl 0.2 mg SC once 1day
pregnylDrug
5000 IU SC
| Study group | Role | What they receive |
|---|---|---|
| hCG | Active comparator | 5000 IU Pregnyl SC Receives: Drug: pregnyl |
| hCG and GnRH agonist | Active comparator | 5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC Receives: Drug: Decapeptyl Daily; Drug: pregnyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
MII Oocytes
the number of mature oocytes retrieved
Measured: 3 weeks
Secondary outcomes (2)
Pregnancy Rate
the number of pregnancies obtained, wich still is the most important issue for the patients
Measured: 12 weeks
Patients With Cryopreserved Embryos
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Jan Palfijn Gent
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouw Hospital
- Responsible party
- Principal investigator, Dr. Decleer Wim, AZ Jan Palfijn Gent
- Investigators
- Wim Decleer, gynacologist, Principal investigator, IVF Centrum Jan Palfijn Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607203
- Sponsor's protocol ID
- Dr. Decleer Wim
- Status last verified
- Feb 2015
- First submitted
- 4 May 2012
- Last updated
- 19 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
- ClinicalTrials.gov ID
- NCT01607203
- Acronym / sponsor ID
- Dr. Decleer Wim
- Conditions
- Infertility
- Keywords
- ovarian hyper stimulation syndrome (OHSS), metaphase II oocytes (MII), good quality embryo's, implantation, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AZ Jan Palfijn GentUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouw Hospital
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Posted 19 Feb 2015
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 see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hCG | Active comparator | Drug: pregnyl5000 IU Pregnyl SC |
| hCG and GnRH agonist | Active comparator | Drug: Decapeptyl Daily, Drug: pregnyl5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC |
Who may qualify
- Ages
- Up to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
- 1,2 or 3 rd IVF-cycle
Key exclusion criteria (2 listed)
- polycystic ovary syndrome (PCOS) patients
- patients with endocrinological diseases or problems
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 |
|---|---|---|
| Decapeptyl DailyAlso: GonapeptylDecapeptyl 0.2 mg SC once 1day | Drug | hCG and GnRH agonist |
| pregnyl5000 IU SC | Drug | hCG, hCG and GnRH agonist |
Primary outcome
MII Oocytes
Time frame: 3 weeks
the number of mature oocytes retrieved
2 secondary outcomes
Pregnancy Rate
Time frame: 12 weeks
Patients With Cryopreserved Embryos
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 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.
Wim Decleer, gynacologist principal investigator
IVF Centrum Jan Palfijn Gent
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 Decapeptyl Daily and pregnyl in people with Infertility, run by AZ Jan Palfijn Gent at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 19 Feb 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 Belgium. 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 19 Feb 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?
MII Oocytes (time frame: 3 weeks). 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 19 Feb 2015.