InfertilityPhase 4NCT00575302
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
A Phase 4 study testing Gonal-f®: follitropin alpha in people with Infertility, run by Centre Hospitalier Chretien at 4 sites in Belgium.
Trial summary
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed. Read more about this study
- Who is it for?
- Ages 38 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Gonal-f®: follitropin alpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesBelgium
- Study dates
- Dec 2007to Dec 2009
- 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 38 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women > 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
- Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
- Patient can be eligible for several cycles in same protocol.
Who cannot join
- Patients who already received doses > 225 IU
- Patients older than 42 years
- Patients with basal FSH concentrations ≥ 15 mU/ml at day 3
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
CHU Saint-Pierre
Brussels, 1000
IMEC
Brussels, 1180
UZ Gent
Ghent, 9000
CHC Saint-Vincent
Rocourt, Liège, 4000
About this study
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.
Read the detailed description
Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:
300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
Patient can be eligible for several cycles in same protocol.
- Conditions
- Infertility
- Being tested
- Gonal-f®: follitropin alpha
- Keywords
- IVF, poor responder, recFSH, Fertilization in Vitro, Poor responders
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-f®: follitropin alphaDrug
Gonal-f®: follitropin alpha, administration of 300 U
Gonal-f®: follitropin alphaDrug
Gonal-f®: follitropin alpha, administration of 450 U
| Study group | Role | What they receive |
|---|---|---|
| 300 | Active comparator | administration of 300 IU Gonal-f® in a short agonist protocol. Receives: Drug: Gonal-f®: follitropin alpha |
| 450 | Experimental | administration of 450 IU Gonal-f® in a short agonist protocol. Receives: Drug: Gonal-f®: follitropin alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of mature oocytes
Measured: 1 month
Secondary outcomes (5)
follicular development
Measured: 1 month
fertilization rate
Measured: 1 month
implantation rate
Measured: 1 month
embryo quality
Measured: 1 month
pregnancy rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: 36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.
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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Chretien
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Investigators
- Annick Delvigne, PhD, Principal investigator, CHC Saint-Vincent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575302
- Sponsor's protocol ID
- Study 300 versus 450
- Status last verified
- Apr 2010
- First submitted
- 17 Dec 2007
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
- ClinicalTrials.gov ID
- NCT00575302
- Acronym / sponsor ID
- Study 300 versus 450
- Conditions
- Infertility
- Keywords
- IVF, poor responder, recFSH, Fertilization in Vitro, Poor responders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier ChretienUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 18 Dec 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.
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.
Detailed description
Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:
300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
Patient can be eligible for several cycles in same protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300 | Active comparator | Drug: Gonal-f®: follitropin alphaadministration of 300 IU Gonal-f® in a short agonist protocol. |
| 450 | Experimental | Drug: Gonal-f®: follitropin alphaadministration of 450 IU Gonal-f® in a short agonist protocol. |
Who may qualify
- Ages
- 38 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women > 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
- Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
- Patient can be eligible for several cycles in same protocol.
Key exclusion criteria (3 listed)
- Patients who already received doses > 225 IU
- Patients older than 42 years
- Patients with basal FSH concentrations ≥ 15 mU/ml at day 3
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 |
|---|---|---|
| Gonal-f®: follitropin alphaGonal-f®: follitropin alpha, administration of 300 U | Drug | 300 |
| Gonal-f®: follitropin alphaGonal-f®: follitropin alpha, administration of 450 U | Drug | 450 |
Primary outcome
number of mature oocytes
Time frame: 1 month
5 secondary outcomes
follicular development
Time frame: 1 month
fertilization rate
Time frame: 1 month
implantation rate
Time frame: 1 month
embryo quality
Time frame: 1 month
pregnancy rate
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
Annick Delvigne, PhD principal investigator
CHC Saint-Vincent
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gonal-f®: follitropin alpha in people with Infertility, run by Centre Hospitalier Chretien at 4 sites 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 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: withdrawn, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
number of mature oocytes (time frame: 1 month). 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 13 Apr 2010.