InfertilityNCT02018159
An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos
An observational study of Infertility, run by Ferring Pharmaceuticals at 1 site in Denmark.
Trial summary
This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- menotropin
- How many people
- 738 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to 12 May 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult
Study population: Women seeking fertility treatment
Who may be able to join
- Age 21-45 years
- In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
- Receiving follicle stimulation with Menopur 600/1200 IU
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)
Horsens
About this study
This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.
- Conditions
- Infertility
- Being tested
- menotropin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menotropinDrug
Also called Menopur
| Study group | Role | What they receive |
|---|---|---|
| Women treated with Menopur | Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled. Receives: Drug: menotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells
Measured: 1 week after oocyte retrieval
Incidence of uneven blastomeres at the 2 and 4 cell stage
Measured: 1 week after oocyte retrieval
Incidence of bi- and multinucleation at 2 cell and 4 cell stage
Measured: 1 week after oocyte retrieval
Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage
Measured: 1 week after oocyte retrieval
Secondary outcomes (5)
Positive serum human Chorion Gonadotrophin (hCG) rate
Measured: 13-15 days after transfer
Implantation rate
Measured: 5 weeks after transfer
Clinical pregnancy rate
Measured: 7 weeks after transfer
Ongoing pregnancy rate
Measured: 10 weeks after transfer
Live birth rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion12 Feb 2016
- Study completion12 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018159
- Sponsor's protocol ID
- 000102
- Status last verified
- Aug 2017
- First submitted
- 17 Dec 2013
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos
- ClinicalTrials.gov ID
- NCT02018159
- Acronym / sponsor ID
- 000102
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 23 Dec 2013 (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.
This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women treated with Menopur | – | Drug: menotropinWomen treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women seeking fertility treatment
Key inclusion criteria (3 listed)
- Age 21-45 years
- In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
- Receiving follicle stimulation with Menopur 600/1200 IU
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| menotropinAlso: Menopur | Drug | Women treated with Menopur |
Primary outcome
Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells
Time frame: 1 week after oocyte retrieval
Incidence of uneven blastomeres at the 2 and 4 cell stage
Time frame: 1 week after oocyte retrieval
Incidence of bi- and multinucleation at 2 cell and 4 cell stage
Time frame: 1 week after oocyte retrieval
Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage
Time frame: 1 week after oocyte retrieval
5 secondary outcomes
Positive serum human Chorion Gonadotrophin (hCG) rate
Time frame: 13-15 days after transfer
Implantation rate
Time frame: 5 weeks after transfer
Clinical pregnancy rate
Time frame: 7 weeks after transfer
Ongoing pregnancy rate
Time frame: 10 weeks after transfer
Live birth rate
Time frame: 9 months
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 28 Aug 2017.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ferring Pharmaceuticals 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 3 inclusion and 0 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 28 Aug 2017. 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.
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?
Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells (time frame: 1 week after oocyte retrieval). The study lists 4 primary outcomes in all. 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 28 Aug 2017.