Female InfertilityNCT01674894
Study of the Cleavage of the Egg in Relation to the Stimulation Treatment
An observational study of Female Infertility, run by Ferring Pharmaceuticals at 1 site in Denmark.
Trial summary
This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment. Read more about this study
- Who is it for?
- Ages 38 to 45 years, women only
- Conditions the study is for
- Female Infertility
- How many people
- 356 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to 10 Mar 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 38 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women suffering from infertility
Who may be able to join
- IVF/ICSI treatment
- Regular cycles of 25-35 days
- Follicle stimulation with Bravelle and/or Menopur
- Women aged 38-35 years
- Long agonist or short antagonist treatment
- Willing and able to understand a Danish, English or German patient information form
- Willing and able to provide written Informed Consent
Who cannot join
- BMI more than 35
- Presence of hydrosalpinx on ultrasound
- FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
- Known allergic reactions to the planned medications
- Use of testicular sperm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetics in Time-lapse Culture of Human Preembryos
This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.
- Conditions
- Female Infertility
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Women treated with Menopur | |
| Group 2 | Women treated with Menopur and Bravelle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
Measured: Week 1 after oocyte retrieval
Time for disappearance of pronuclei in transferred embryos
Measured: Week 1 after oocyte retrieval
Time for first cleavage in transferred embryos
Measured: Week 1 after oocyte retrieval
Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos
Measured: Week 1 after oocyte retrieval
Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage
Measured: Week 1 after oocyte retrieval
Secondary outcomes (8)
Total dose of gonadotrophin used
Measured: 1 month
Gonadotrophin dose per oocyte retrieved
Measured: 1 month
Number of oocytes retrieved
Measured: 1 month
Number of fertilized and cleaved oocytes
Measured: 1 month
Number of preembryos with top quality
Measured: 1 month
Implantation rate
Measured: 2 months
Ongoing pregnancy rate week 7
Measured: 3 months
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 posted29 Aug 2012 (estimated)
- Study startJan 2013
- Primary completion10 Dec 2015
- Study completion10 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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
- 356 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
- NCT01674894
- Sponsor's protocol ID
- 000063
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2012
- 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
- Kinetics in Time-lapse Culture of Human Preembryos
- ClinicalTrials.gov ID
- NCT01674894
- Acronym / sponsor ID
- 000063
- Conditions
- Female Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 29 Aug 2012 (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, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Women treated with Menopur |
| Group 2 | – | –Women treated with Menopur and Bravelle |
Who may qualify
- Ages
- 38 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women suffering from infertility
Key inclusion criteria (7 listed)
- IVF/ICSI treatment
- Regular cycles of 25-35 days
- Follicle stimulation with Bravelle and/or Menopur
- Women aged 38-35 years
- Long agonist or short antagonist treatment
Key exclusion criteria (5 listed)
- BMI more than 35
- Presence of hydrosalpinx on ultrasound
- FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
- Known allergic reactions to the planned medications
- Use of testicular sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
Time frame: Week 1 after oocyte retrieval
Time for disappearance of pronuclei in transferred embryos
Time frame: Week 1 after oocyte retrieval
Time for first cleavage in transferred embryos
Time frame: Week 1 after oocyte retrieval
Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos
Time frame: Week 1 after oocyte retrieval
Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage
Time frame: Week 1 after oocyte retrieval
8 secondary outcomes
Total dose of gonadotrophin used
Time frame: 1 month
Gonadotrophin dose per oocyte retrieved
Time frame: 1 month
Number of oocytes retrieved
Time frame: 1 month
Number of fertilized and cleaved oocytes
Time frame: 1 month
Number of preembryos with top quality
Time frame: 1 month
Implantation rate
Time frame: 2 months
Ongoing pregnancy rate week 7
Time frame: 3 months
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 Female 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 7 inclusion and 5 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?
Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection) (time frame: Week 1 after oocyte retrieval). The study lists 5 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.