Aneuploidy RateNCT01164943
Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
A study testing Stimulation with human FSH and Stimulation with recombinant FSH in people with Aneuploidy Rate, run by IVI Madrid at 1 site in Spain.
Trial summary
Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy Rate
- What is being tested?
- Stimulation with human FSH and Stimulation with recombinant FSH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Dec 2012
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Egg donation cycles with more than 8MII in oocyte retrieval day
Who cannot join
- Male factor
- Uterine malformations
- genetic alterations
Trial locations and contacts
1 site in 1 country.
Spain1 site
Insituto Valenciano de Infertilida, Spain, Madrid
Madrid, Madrid, 28023
About this study
Official title: Aneuploidy Rate Impact in Oocyte From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH
Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.
- Conditions
- Aneuploidy Rate
- Being tested
- Stimulation with human FSH, Stimulation with recombinant FSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation with human FSHProcedure or surgery
Human FSH
Stimulation with recombinant FSHProcedure or surgery
Recombinant FSH
| Study group | Role | What they receive |
|---|---|---|
| Human FSH | Active comparator | Not described Receives: Procedure: Stimulation with human FSH |
| Recombinant FSH | Active comparator | Not described Receives: Procedure: Stimulation with recombinant FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneuploidy Rate
Analysis of all nuclei fixed
Measured: 2011 January
Secondary outcomes (2)
Oocyte morphology
Analysis of all oocytes
Measured: 2011 january
Outcome rates (implantation, pregnancy and miscarriage rate)
Time requierd to know all the implantation, pregnancy and miscarriage rate
Measured: 2011 April
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneuploidy RateStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan A Garcia-Velasco, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164943
- Sponsor's protocol ID
- MAD-FB-04-2010-01
- Status last verified
- Apr 2015
- First submitted
- 16 Jul 2010
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneuploidy Rate Impact in Oocyte From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH
- ClinicalTrials.gov ID
- NCT01164943
- Acronym / sponsor ID
- MAD-FB-04-2010-01
- Conditions
- Aneuploidy Rate
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jul 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.
Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human FSH | Active comparator | Procedure: Stimulation with human FSH |
| Recombinant FSH | Active comparator | Procedure: Stimulation with recombinant FSH |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Egg donation cycles with more than 8MII in oocyte retrieval day
Key exclusion criteria (3 listed)
- Male factor
- Uterine malformations
- genetic alterations
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 |
|---|---|---|
| Stimulation with human FSHHuman FSH | Procedure or surgery | Human FSH |
| Stimulation with recombinant FSHRecombinant FSH | Procedure or surgery | Recombinant FSH |
Primary outcome
Aneuploidy Rate
Time frame: 2011 January
Analysis of all nuclei fixed
2 secondary outcomes
Oocyte morphology
Time frame: 2011 january
Outcome rates (implantation, pregnancy and miscarriage rate)
Time frame: 2011 April
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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 study testing Stimulation with human FSH and Stimulation with recombinant FSH in people with Aneuploidy Rate, run by IVI Madrid 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 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: stopped early, as of the sponsor's last update on 25 Feb 2016. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Aneuploidy Rate (time frame: 2011 January). 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 25 Feb 2016.