Patients for In Vitro Fertilization(IVF)TreatmentPhase 4NCT01345812
Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.
A Phase 4 study testing HP-HMG and recombinant FSH in people with Patients for In Vitro Fertilization(IVF)Treatment, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary purpose of the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Patients for In Vitro Fertilization(IVF)Treatment
- What is being tested?
- HP-HMG and recombinant FSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Aug 2012
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants(heterosexuals, lesbian couples and single women) must sign a document of informed consent
- Female age 21-45 years(both inclusive)
- Patients for IVF treatment
- Regular menstrual cycle 21-35 days(both inclusive)
- Normal FSH levels(1-15 IU/L)
- BMI between 18-32(both inclusive)
- Patients must be able to read and understand patient information in national language
Who cannot join
- PCO
- Endometriosis as primary diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-lapse Assessed Evaluation of Embryo Development After Stimulation With Either Recombinant Follicle Stimulating Hormone (FSH) or Urine-derived Follicle Stimulating Hormone (FSH).
The primary purpose of the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins.
Read the detailed description
So far the assessment of the development potential of the single embryo has been limited by the vulnerability of the embryos when exposed to fluctuations in temperature and CO2 levels.
Thus embryos can only be allowed to leave incubators for a very limited time period.
However, with the development of time-lapse systems for clinical use it is possible to make continuous time-lapse recordings of embryos while they are in a safe incubator environment.
The embryos are not compromised, but the entire embryonic development can still be seen, and will subsequently provide new and essential information on the competence of the single embryo.
Based on the above it is expected that the probability of selecting the most viable and competent embryo is increased, which, in turn, will increase the success rate for couples seeking infertility treatment.
- Being tested
- HP-HMG, recombinant FSH
- Keywords
- ART, IVF, Timelapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP-HMGDrug
Also called Menopure
100 - 300 IU for stimulation of women in ART treatment
recombinant FSHDrug
Also called Gonal-F
100 -300 IU for stimulation of women in ART treatment
| Study group | Role | What they receive |
|---|---|---|
| urine-derived FSH | Active comparator | Follicle stimulating hormone Receives: Drug: HP-HMG |
| recombinant FSH | Active comparator | Follicle stimulation hormone Receives: Drug: recombinant FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Top Quality Embryos day 2
The oocytes are inseminated and loaded to the time-lapse instrument and cultured for two days. The embryo developemnt are followed at the movie and the embryos are scored according to a standard scoring criteria at 44 h after insemination
Measured: 44 h after insemination
Secondary outcomes (1)
Implantation rate
The pregnancy is verified by a blood sample two weeks after embryo transfer and the number of embryos implanted are verified by ultrasound scanning five weeks after embryo transfer.
Measured: 5 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionAug 2012
Why it stopped: Lack of patients for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients for In Vitro Fertilization(IVF)TreatmentStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Fertility Clinic Braedstrup Hospital, Herlev Hospital, Odense University Hospital, Trianglen Fertility Clinic, Aagaard Fertility Clinic, Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Inge Agerholm, Phd, Principal investigator, IVF clinic Braedstrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345812
- Sponsor's protocol ID
- 20090169
- Status last verified
- Sep 2012
- First submitted
- 29 Apr 2011
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-lapse Assessed Evaluation of Embryo Development After Stimulation With Either Recombinant Follicle Stimulating Hormone (FSH) or Urine-derived Follicle Stimulating Hormone (FSH).
- ClinicalTrials.gov ID
- NCT01345812
- Acronym / sponsor ID
- 20090169
- Keywords
- ART, IVF, Timelapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients for recruitment
- Enrolment
- 291 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Fertility Clinic Braedstrup Hospital, Herlev Hospital, Odense University Hospital, Trianglen Fertility Clinic, Aagaard Fertility Clinic, Ferring Pharmaceuticals
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 May 2011 (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 the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins.
Detailed description
So far the assessment of the development potential of the single embryo has been limited by the vulnerability of the embryos when exposed to fluctuations in temperature and CO2 levels.
Thus embryos can only be allowed to leave incubators for a very limited time period.
However, with the development of time-lapse systems for clinical use it is possible to make continuous time-lapse recordings of embryos while they are in a safe incubator environment.
The embryos are not compromised, but the entire embryonic development can still be seen, and will subsequently provide new and essential information on the competence of the single embryo.
Based on the above it is expected that the probability of selecting the most viable and competent embryo is increased, which, in turn, will increase the success rate for couples seeking infertility treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urine-derived FSH | Active comparator | Drug: HP-HMGFollicle stimulating hormone |
| recombinant FSH | Active comparator | Drug: recombinant FSHFollicle stimulation hormone |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants(heterosexuals, lesbian couples and single women) must sign a document of informed consent
- Female age 21-45 years(both inclusive)
- Patients for IVF treatment
- Regular menstrual cycle 21-35 days(both inclusive)
- Normal FSH levels(1-15 IU/L)
Key exclusion criteria (2 listed)
- PCO
- Endometriosis as primary diagnosis
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 |
|---|---|---|
| HP-HMGAlso: Menopure100 - 300 IU for stimulation of women in ART treatment | Drug | urine-derived FSH |
| recombinant FSHAlso: Gonal-F100 -300 IU for stimulation of women in ART treatment | Drug | recombinant FSH |
Primary outcome
Number of Top Quality Embryos day 2
Time frame: 44 h after insemination
The oocytes are inseminated and loaded to the time-lapse instrument and cultured for two days. The embryo developemnt are followed at the movie and the embryos are scored according to a standard scoring criteria at 44 h after insemination
1 secondary outcome
Implantation rate
Time frame: 5 weeks after embryo transfer
Results and safety
The study was stopped early (reason given: Lack of patients for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- databaseLink provided by the sponsor.
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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.
Inge Agerholm, Phd principal investigator
IVF clinic Braedstrup
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 HP-HMG and recombinant FSH in people with Patients for In Vitro Fertilization(IVF)Treatment, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 2 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 14 Sep 2012. 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 Denmark. 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 stopped early (reason given: Lack of patients for recruitment). 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?
Number of Top Quality Embryos day 2 (time frame: 44 h after insemination). 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 14 Sep 2012.