InfertilityPhase 4NCT01683513
Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients
A Phase 4 study testing GnRh agonist +1500E hCG in people with Infertility and PCOS, run by AZ Jan Palfijn Gent at 1 site in Belgium.
Trial summary
In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, PCOS
- What is being tested?
- GnRh agonist +1500E hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Feb 2015
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ICSI patients below 38 years
- 1, 2 and 3e IVF cycle
- Body Mass Index (BMI) less than 32
- PCOS patients
Who cannot join
- endocrinal diseases or problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients
In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.
- Conditions
- Infertility, PCOS
- Being tested
- GnRh agonist +1500E hCG
- Keywords
- OHSS, mataphase II oocytes (MII), good quality embryo's, pregnancy
- 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 +1500E hCGDrug
ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval
| Study group | Role | What they receive |
|---|---|---|
| humaan chorion gonadotropine | No intervention | ovulation induction with 5000E hCG |
| GnRH agonist + 1500E hCG | Active comparator | ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval Receives: Drug: GnRh agonist +1500E hCG |
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 after stimulation without creating OHSS
Measured: patients will be followed during the stimulation with an average of 10 days
2 Pro Nuclei (2PN) fertilization
laboratory follow up of the fertilized egg during the first 24h
Measured: 24h after ICSI
Secondary outcomes (2)
implantation rate
The number of pregnancies obtained wich still is the most important issue for the patients
Measured: 12 weeks
OHSS
patient follow up according to subjective complaints and objective measures
Measured: one month with oocyte retrieval in the middle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2015
- Study completionFeb 2015
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
- 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, gynecologist, Principal investigator, IVF Centrum Jan Palfijn Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683513
- Sponsor's protocol ID
- Dr. Decleer W
- Status last verified
- Feb 2021
- First submitted
- 23 Aug 2012
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients
- ClinicalTrials.gov ID
- NCT01683513
- Acronym / sponsor ID
- Dr. Decleer W
- Conditions
- Infertility, PCOS
- Keywords
- OHSS, mataphase II oocytes (MII), good quality embryo's, 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
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Sep 2012 (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.
In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| humaan chorion gonadotropine | No intervention | –ovulation induction with 5000E hCG |
| GnRH agonist + 1500E hCG | Active comparator | Drug: GnRh agonist +1500E hCGovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ICSI patients below 38 years
- 1, 2 and 3e IVF cycle
- Body Mass Index (BMI) less than 32
- PCOS patients
Key exclusion criteria (1 listed)
- endocrinal 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 |
|---|---|---|
| GnRh agonist +1500E hCGovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval | Drug | GnRH agonist + 1500E hCG |
Primary outcome
MII oocytes
Time frame: patients will be followed during the stimulation with an average of 10 days
The number of mature oocytes retrieved after stimulation without creating OHSS
2 Pro Nuclei (2PN) fertilization
Time frame: 24h after ICSI
laboratory follow up of the fertilized egg during the first 24h
2 secondary outcomes
implantation rate
Time frame: 12 weeks
OHSS
Time frame: one month with oocyte retrieval in the middle
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 2 Feb 2021.
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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, gynecologist 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 GnRh agonist +1500E hCG in people with Infertility and PCOS, 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 4 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 2 Feb 2021. 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?
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?
MII oocytes (time frame: patients will be followed during the stimulation with an average of 10 days). The study lists 2 primary outcomes in all. 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 2 Feb 2021.