InfertilityPhase 4NCT01093443
Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days
A Phase 4 study testing ovarian stimulation in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- ovarian stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2009to May 2010
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- < 39 years old on day of randomisation
- FSH < 12 (in the early follicular phase)
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- BMI between 18 and 29 (both inclusive)
- 1st or 2nd trial
- IVF or ICSI
- Randomisation at out-patient clinic
Who cannot join
- ≥ 39 years old on day of randomisation
- Endometriosis ≥ grade 3
- PCOS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI
In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.
Read the detailed description
A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.
- Conditions
- Infertility
- Being tested
- ovarian stimulation
- Keywords
- IVF, ICSI, GnRH antagonist, pretreatment
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian stimulationDrug
rFSH with GnRH antagonists
ovarian stimulationDrug
GnRH antagonist, rFSH, GnRH antagonist
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Patients undergo a standard treatment with a classical GnRH antagonist protocol. Receives: Drug: ovarian stimulation |
| B | Active comparator | Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days Receives: Drug: ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrine profile
The purpose is to assess the endocrine profile in each treatment group
Measured: up to 9 months
Secondary outcomes (1)
Pregnancy rate
The purpose is to study the pregnancy rate in each treatment group
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
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.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093443
- Sponsor's protocol ID
- 2009/196
- Status last verified
- Nov 2009
- First submitted
- 24 Mar 2010
- Last updated
- 11 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI
- ClinicalTrials.gov ID
- NCT01093443
- Acronym / sponsor ID
- 2009/196
- Conditions
- Infertility
- Keywords
- IVF, ICSI, GnRH antagonist, pretreatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 25 Mar 2010 (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 prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.
Detailed description
A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: ovarian stimulationPatients undergo a standard treatment with a classical GnRH antagonist protocol. |
| B | Active comparator | Drug: ovarian stimulationBefore undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- < 39 years old on day of randomisation
- FSH < 12 (in the early follicular phase)
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- BMI between 18 and 29 (both inclusive)
Key exclusion criteria (3 listed)
- ≥ 39 years old on day of randomisation
- Endometriosis ≥ grade 3
- PCOS
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 |
|---|---|---|
| ovarian stimulationrFSH with GnRH antagonists | Drug | A |
| ovarian stimulationGnRH antagonist, rFSH, GnRH antagonist | Drug | B |
Primary outcome
Endocrine profile
Time frame: up to 9 months
The purpose is to assess the endocrine profile in each treatment group
1 secondary outcome
Pregnancy rate
Time frame: up to 9 months
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 11 Oct 2010.
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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 ovarian stimulation in people with Infertility, run by Universitair Ziekenhuis Brussel 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 8 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 11 Oct 2010. 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. Some participants in this study may receive a placebo. 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?
Endocrine profile (time frame: up to 9 months). 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 11 Oct 2010.