Infertility, FemaleNCT01882166
Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
A study testing fostimon and puregon in people with Infertility, Female, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short "time to pregnancy" with impact on both economical aspects for the society and medical and psychological aspects for the… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- fostimon and puregon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to 1 Jan 2015
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- First or second intracytoplasmic sperm injection (ICSI) treatment
- BMI 18-32 kg/m²
- No previous ovarian hyperstimulation syndrome (OHSS)
- Regular menstrual cycle (cycle length 28 ± 3 days
- Less than 20 antral follicles evaluated by vaginal ultrasound
- S- Anti-Müller Hormone (AMH) 10 - 40 pmol/L
- has given informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short "time to pregnancy" with impact on both economical aspects for the society and medical and psychological aspects for the couple. During treatment, success relies on 1) optimal stimulation of growth and maturation of multiple follicles by administration of exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo with the highest potential of implantation to be transferred to the mother. In the present project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared. To this end early embryo development and kinetics after fertilization will be evaluated. The system to be used is time-lapse recording of embryo morphology during the first days of embryo development by means of an embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have different effect on embryo quality. The hypothesis of the study is that stimulation of egg production by these two types of follicle stimulating hormone does not have the same effect on early embryo quality.
- Conditions
- Infertility, Female
- Being tested
- fostimon, puregon
- Keywords
- Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Follicle Stimulating Hormone, Embryonic Development
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fostimonDrug
Also called urinary FSH
puregonDrug
Also called recombinant FSH
| Study group | Role | What they receive |
|---|---|---|
| fostimon | Experimental | subcutaneous 150 IE Fostimon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later. Receives: Drug: fostimon |
| puregon | Experimental | subcutaneous 150 IE Puregon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later. Receives: Drug: puregon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo quality
time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startOct 2013
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
Why it stopped: principal investigator left for another job, project leader retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arne Sunde, phd, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882166
- Sponsor's protocol ID
- 2013/600
- Status last verified
- Sep 2018
- First submitted
- 17 Jun 2013
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
- ClinicalTrials.gov ID
- NCT01882166
- Acronym / sponsor ID
- 2013/600
- Conditions
- Infertility, Female
- Keywords
- Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Follicle Stimulating Hormone, Embryonic Development
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: principal investigator left for another job, project leader retired
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 20 Jun 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.
The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short "time to pregnancy" with impact on both economical aspects for the society and medical and psychological aspects for the couple. During treatment, success relies on 1) optimal stimulation of growth and maturation of multiple follicles by administration of exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo with the highest potential of implantation to be transferred to the mother. In the present project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared. To this end early embryo development and kinetics after fertilization will be evaluated. The system to be used is time-lapse recording of embryo morphology during the first days of embryo development by means of an embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have different effect on embryo quality. The hypothesis of the study is that stimulation of egg production by these two types of follicle stimulating hormone does not have the same effect on early embryo quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fostimon | Experimental | Drug: fostimonsubcutaneous 150 IE Fostimon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later. |
| puregon | Experimental | Drug: puregonsubcutaneous 150 IE Puregon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- First or second intracytoplasmic sperm injection (ICSI) treatment
- BMI 18-32 kg/m²
- No previous ovarian hyperstimulation syndrome (OHSS)
- Regular menstrual cycle (cycle length 28 ± 3 days
- Less than 20 antral follicles evaluated by vaginal ultrasound
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 |
|---|---|---|
| fostimonAlso: urinary FSH | Drug | fostimon |
| puregonAlso: recombinant FSH | Drug | puregon |
Primary outcome
Embryo quality
Time frame: 2 days
time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)
Results and safety
The study was stopped early (reason given: principal investigator left for another job, project leader retired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
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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.
Arne Sunde, phd study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fostimon and puregon in people with Infertility, Female, run by St. Olavs Hospital at 1 site in Norway.
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 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: stopped early, as of the sponsor's last update on 14 Sep 2018. 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 Norway. 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 (reason given: principal investigator left for another job, project leader retired). 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?
Embryo quality (time frame: 2 days). 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 2018.