Effect of Two Protocols of Ovarian Stimulation on Oocyte QualityPhase 4NCT00505817
GnRH Agonist and Antagonists in an Oocyte Donation Program
A Phase 4 study testing Cetrorelix and Leuprolide in people with Effect of Two Protocols of Ovarian Stimulation on Oocyte Quality, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Effect of Two Protocols of Ovarian Stimulation on Oocyte Quality
- What is being tested?
- Cetrorelix and Leuprolide
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- 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
- Adult
Who may be able to join
- oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;
Who cannot join
- PCO
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Valenciano de Infertilidad Spain
Valencia, Valencia, 46015
About this study
The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.
Read the detailed description
The cycles with antagonists of the GnRHa present a series of advantages with respect the GnRHa in an oocyte donation program: treatment cycles are simpler and shorter, a lower amount of dose of gonadotrophins is needed for stimulation, and most important, a decreased rate of ovarian hyperstimulation syndrome is observed. Nevertheless, several clinical trials relate their use to a greater rate of abortion and worse oocyte/ embryo quality. In order to discriminate the endometrial factor from the quality of oocyte cohort, the best strategy is the oocyte donation model. In the present study, for the first time, the effect of different protocols (long versus antagonist protocol) will be studied in the same donor, acting as its own control, undergoing COH. We will compare the COH´s parameters and IVF outcome obtained in the same donor submitted to, firstly, GnRH antagonist protocol (Cetrorelix- n= 45) versus another consecutive cycle with long protocol (Ac. Leuprolide- n= 45).
- Being tested
- Cetrorelix and Leuprolide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix and LeuprolideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Two Protocols of Ovarian Stimulation on Oocyte QualityStudies 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Marco Melo, MDPhD, Principal investigator, Instituto Valenciano de Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505817
- Sponsor's protocol ID
- VLC-MM-0706-307-19
- Status last verified
- Jan 2009
- First submitted
- 23 Jul 2007
- Last updated
- 12 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRH Agonist and Antagonists in an Oocyte Donation Program
- ClinicalTrials.gov ID
- NCT00505817
- Acronym / sponsor ID
- VLC-MM-0706-307-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- First posted
- 25 Jul 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.
The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.
Detailed description
The cycles with antagonists of the GnRHa present a series of advantages with respect the GnRHa in an oocyte donation program: treatment cycles are simpler and shorter, a lower amount of dose of gonadotrophins is needed for stimulation, and most important, a decreased rate of ovarian hyperstimulation syndrome is observed. Nevertheless, several clinical trials relate their use to a greater rate of abortion and worse oocyte/ embryo quality. In order to discriminate the endometrial factor from the quality of oocyte cohort, the best strategy is the oocyte donation model. In the present study, for the first time, the effect of different protocols (long versus antagonist protocol) will be studied in the same donor, acting as its own control, undergoing COH. We will compare the COH´s parameters and IVF outcome obtained in the same donor submitted to, firstly, GnRH antagonist protocol (Cetrorelix- n= 45) versus another consecutive cycle with long protocol (Ac. Leuprolide- n= 45).
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;
Key exclusion criteria (1 listed)
- PCO
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 |
|---|---|---|
| Cetrorelix and Leuprolide | Drug | – |
Primary outcome
Not reported in the source record.
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 12 Jan 2009.
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
Instituto Valenciano de Infertilidad
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 Cetrorelix and Leuprolide in people with Effect of Two Protocols of Ovarian Stimulation on Oocyte Quality, 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 1 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 12 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.
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 12 Jan 2009.