Ovarian StimulationPhase 4NCT00829075
Impact of Three Different Gonadotrophin Regimes on Egg Donation Program
A Phase 4 study testing r-FSH, HP-hMG and r-FSH plus HP-hMG in people with Ovarian Stimulation, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Stimulation
- What is being tested?
- r-FSH, HP-hMG and r-FSH plus HP-hMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Dec 2006
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women 18-34 years of age
- regular menstrual cycles
- no family history of hereditary or chromosomal diseases
- normal karyotype
- BMI 18-29 Kg/m2
- negative screening for sexually transmitted diseases
Who cannot join
- women with PCOS were not included in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome
Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.
- Conditions
- Ovarian Stimulation
- Being tested
- r-FSH, HP-hMG, r-FSH plus HP-hMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-FSHDrug
HP-hMGDrug
r-FSH plus HP-hMGDrug
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | only r-FSH TREATMENT Receives: Drug: r-FSH |
| II | Experimental | only HP-hMG TREATMENT Receives: Drug: HP-hMG |
| III | Experimental | r-FSH plus HP-hMG TREATMENT Receives: Drug: r-FSH plus HP-hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian StimulationStudies 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
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Marco Melo, MDPhD, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829075
- Sponsor's protocol ID
- VLC-MM-0501-37
- Status last verified
- Jan 2009
- First submitted
- 23 Jan 2009
- Last updated
- 26 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome
- ClinicalTrials.gov ID
- NCT00829075
- Acronym / sponsor ID
- VLC-MM-0501-37
- Conditions
- Ovarian Stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Jan 2009 (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.
Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: r-FSHonly r-FSH TREATMENT |
| II | Experimental | Drug: HP-hMGonly HP-hMG TREATMENT |
| III | Experimental | Drug: r-FSH plus HP-hMGr-FSH plus HP-hMG TREATMENT |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy women 18-34 years of age
- regular menstrual cycles
- no family history of hereditary or chromosomal diseases
- normal karyotype
- BMI 18-29 Kg/m2
Key exclusion criteria (1 listed)
- women with PCOS were not included in this study
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 |
|---|---|---|
| r-FSH | Drug | I |
| HP-hMG | Drug | II |
| r-FSH plus HP-hMG | Drug | III |
Primary outcome
The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program.
Time frame: one year
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 26 Jan 2009.
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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.
Marco Melo, MDPhD principal investigator
IVI Valencia
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 r-FSH, HP-hMG and r-FSH plus HP-hMG in people with Ovarian Stimulation, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 6 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 26 Jan 2009. 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 Spain. 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?
The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program. (time frame: one year). 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 26 Jan 2009.