Embryo AneuploidiesPhase 4NCT00707525
Embryo Aneuploidies and Ovarian Stimulation
A Phase 4 study testing Preimplantation Genetic Diagnosis in people with Embryo Aneuploidies, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Aneuploidies
- What is being tested?
- Preimplantation Genetic Diagnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Feb 2008to Feb 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Donor Inclusion Criteria:
- 18 to 35 years old.
- BMI: 18-25Kg/m2
- Regular menstrual cycles
- Normal kariotype
- No previous controlled ovarian hyperstimulation (COH) treatments.
Donor Exclusion Criteria:
- Endometriosis
- Policystic ovarian syndrome
- Recurrent miscarriages.
Recipient Inclusion Criteria
- Aged until 45 years old
- No systemic diseases
- Following egg and sperm donation treatment.
Recipient exclusion criteria:
- Uterine disease (polyps, myomas, mullerian defects)
- Recurrent miscarriages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.
There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos.
The main question remaining is if COH may increase the aneuploidies rate in young and healthy women. Therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the male factor influence, donated sperm will be used.
- Conditions
- Embryo Aneuploidies
- Being tested
- Preimplantation Genetic Diagnosis
- Keywords
- aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic DiagnosisProcedure or surgery
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Natural cycle oocyte donation |
| 2 | Active comparator | Stimulated cycle oocyte donation.
* Long protocol down-regulation with a GnRH agonist, starting on the midluteal phase of the previous cycle with leuprolide acetate (0.2mg/day).
* Once evidence of downregulation is documented, leuprolide will be halved to 0.1 mg daily.
* COH with be carried on with gonadotropins (150UI/day of rFSH and 75 UI/day of HP-hMG). The dose can be adjusted according to ovarian response as judged by ultrasound and by serum oestradiol (E 2 ) concentrations. Receives: Procedure: Preimplantation Genetic Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo aneuploidies
Measured: 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embryo AneuploidiesStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707525
- Sponsor's protocol ID
- 0607-C-M09-EL
- Status last verified
- Mar 2010
- First submitted
- 30 Jun 2008
- Last updated
- 26 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Labarta E, Bosch E, Alama P, Rubio C, Rodrigo L, Pellicer A. Moderate ovarian stimulation does not increase the incidence of human embryo chromosomal abnormalities in in vitro fertilization cycles. J Clin Endocrinol Metab. 2012 Oct;97(10):E1987-94. doi: 10.1210/jc.2012-1738. Epub 2012 Aug 3.
PubMed 22865900
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.
- ClinicalTrials.gov ID
- NCT00707525
- Acronym / sponsor ID
- 0607-C-M09-EL
- Conditions
- Embryo Aneuploidies
- Keywords
- aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Jul 2008 (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.
There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos.
The main question remaining is if COH may increase the aneuploidies rate in young and healthy women. Therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the male factor influence, donated sperm will be used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Natural cycle oocyte donation |
| 2 | Active comparator | Procedure: Preimplantation Genetic DiagnosisStimulated cycle oocyte donation. * Long protocol down-regulation with a GnRH agonist, starting on the midluteal phase of the previous cycle with leuprolide acetate (0.2mg/day). * Once evidence of downregulation is documented, leuprolide will be halved to 0.1 mg daily. * COH with be carried on with gonadotropins (150UI/day of rFSH and 75 UI/day of HP-hMG). The dose can be adjusted according to ovarian response as judged by ultrasound and by serum oestradiol (E 2 ) concentrations. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Preimplantation Genetic DiagnosisPreimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles. | Procedure or surgery | 2 |
Primary outcome
Embryo aneuploidies
Time frame: 2 cycles
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 Mar 2010.
- Derived from this study: PubMed 22865900Labarta E, Bosch E, Alama P, Rubio C, Rodrigo L, Pellicer A. Moderate ovarian stimulation does not increase the incidence of human embryo chromosomal abnormalities in in vitro fertilization cycles. J Clin Endocrinol Metab. 2012 Oct;97(10):E1987-94. doi: 10.1210/jc.2012-1738. Epub 2012 Aug 3.
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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 Preimplantation Genetic Diagnosis in people with Embryo Aneuploidies, 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?
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 Mar 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 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?
Embryo aneuploidies (time frame: 2 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707525, which also lists 1 linked publication.
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 Mar 2010.