InfertilityNCT02610114
Improvement of Cell Selection in Reproductive Techniques
A study testing Z-Score and computer algorithm and Z-Score in people with Infertility, run by Jürgen Weiss at 1 site in Switzerland.
Trial summary
It is the aim of this trial to use a new computerized cell selection method, in addition to the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- Z-Score and computer algorithm and Z-Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with age 18 years or older
- Man with age 18 years or older
- Couples who could gain fertilized cells after In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI) after hormonal stimulation due to sterility treatments
- Couples presenting negative blood samples of human immunodeficiency virus (HIV) and Hepatitis B/C
- Signed routine contracts between hospital and patient wanting assisted reproductive technology (ART)
- Signed informed study consent
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- Expectation of life more than 18 years
- No medical contraindication to become pregnant (female)
- Routine criteria for assisted reproductive techniques
Who cannot join
- Poor health status acc. to Investigator's judgement
- Expectation of life below 18 years
- Risk of ovarian hyperstimulation syndrome
- Avital cells (cells that do not further develop or die)
- Treatment due to fertility preservation, e.g. in case of cancer
- Problems after stimulation and follicle puncture
Show all 11Show fewer
- Endometrial pathologies like polyps, submucous fibroids, etc.
- Any preceding stimulation cycle with endometrial thickness below 6mm
- Less than 4 fertilized oocytes
- Patient (and partner) wishes single embryo Transfer
- Failure to become pregnant with new zygote selection method
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Neue Frauenklinik
Lucerne, 6000 Luzern 16
Jürgen Weiss, Professor, +41 41 205 36 08, juergen.weiss@luks.ch
Roger Getzmann, +41 41 205 28 40, roger.getzmann@luks.ch
About this study
Official title: A New Method to Improve the Selection of Zygotes in the Context of Assisted Reproductive Medicine. A Randomized Controlled Blinded Monocenter Study
It is the aim of this trial to use a new computerized cell selection method, in addition to the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques.
Read the detailed description
It is the aim of this trial to use a new computerized selection method, in addition to the current and world-wide used scoring system of fertilized oocytes (zygotes) implemented by Scott in 1998, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques. If successful this could in the future lead to a reduction in the numbers of embryos required to achieve a pregnancy. Transferring only one embryo means minimizing the incidence of high order multiple pregnancies.
Regularly couples gain several fertilized oocytes (zygotes) due to artificial reproductive techniques. As a routine, these cells are archived using pictures and videos for quality and safety reasons in different stages of development. Because it is planned to transfer only one or two developed embryos to the uterus, investigators have to select the zygotes with the highest potential for implantation and pregnancy. The remaining cells are preserved using vitrification.
In the study, investigators use in addition to the established Zygote-score (Z-score) by Scott a new selection method for one group of patients: The quality of the zygotes of all patients is classified according to the described Scott system. Patients are randomized to two groups. Group 1 is the control group without any further intervention. If needed for selection, the quality of the zygotes of the patients of group 2 is additionally scored with a new method. The pictures of the cells, already taken for quality and safety reasons, are taken and the cells surface is analysed using a computer algorithm.
- Conditions
- Infertility
- Being tested
- Z-Score and computer algorithm, Z-Score
- Keywords
- Assisted reproductive technology (ART), zygotes, Z-score (Zygote Score), Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-Score and computer algorithmOther
In addition to the routine Z-score for zygote selection, if needed, the photographs of the zygotes already taken for quality and safety reasons are analysed using the new computer algorithm. Within a few minutes it generates a score, determining the quality of the cells. The two best cells upon Z-score result and new computer algorithm result are selected for first transfer.
Z-ScoreOther
After fertilisation pronuclei and nucleoli can be seen inside the cells by microscope. Routinely, the alignment of nucleoli can be used generating a score, the Z-score 1-4, established by Scott. Two zygotes getting the best Z-score are selected for cell culture and the cells that develop to embryo stage are used for first transfer.
| Study group | Role | What they receive |
|---|---|---|
| Z-Score and computer algorithm | Experimental | Not described Receives: Other: Z-Score and computer algorithm |
| Z-Score | Active comparator | Not described Receives: Other: Z-Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Clinical pregnancy is defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Measured: min. 4 weeks after embryo transfer
Secondary outcomes (2)
Ongoing clinical pregnancy
Clinical pregnancy is defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Measured: min. 9 weeks after embryo transfer
Life Birth
A live birth is defined as the complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscle, irrespective of whether the umbilical cord has been cut or the placenta is attached.
Measured: through study completion, an average of 40 weeks after last menstrual period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2018 (estimated)
- Study completionNov 2018 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jürgen Weiss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jürgen Weiss, Luzerner Kantonsspital
- Investigators
- Jürgen Weiss, Professor, Study chair, Luzerner Kantonsspital, Neue Frauenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610114
- Sponsor's protocol ID
- REPROLUKS 002
- Status last verified
- Mar 2017
- First submitted
- 5 Nov 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method to Improve the Selection of Zygotes in the Context of Assisted Reproductive Medicine. A Randomized Controlled Blinded Monocenter Study
- ClinicalTrials.gov ID
- NCT02610114
- Acronym / sponsor ID
- REPROLUKS 002
- Conditions
- Infertility
- Keywords
- Assisted reproductive technology (ART), zygotes, Z-score (Zygote Score), Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jürgen WeissUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 20 Nov 2015 (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.
It is the aim of this trial to use a new computerized cell selection method, in addition to the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques.
Detailed description
It is the aim of this trial to use a new computerized selection method, in addition to the current and world-wide used scoring system of fertilized oocytes (zygotes) implemented by Scott in 1998, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques. If successful this could in the future lead to a reduction in the numbers of embryos required to achieve a pregnancy. Transferring only one embryo means minimizing the incidence of high order multiple pregnancies.
Regularly couples gain several fertilized oocytes (zygotes) due to artificial reproductive techniques. As a routine, these cells are archived using pictures and videos for quality and safety reasons in different stages of development. Because it is planned to transfer only one or two developed embryos to the uterus, investigators have to select the zygotes with the highest potential for implantation and pregnancy. The remaining cells are preserved using vitrification.
In the study, investigators use in addition to the established Zygote-score (Z-score) by Scott a new selection method for one group of patients: The quality of the zygotes of all patients is classified according to the described Scott system. Patients are randomized to two groups. Group 1 is the control group without any further intervention. If needed for selection, the quality of the zygotes of the patients of group 2 is additionally scored with a new method. The pictures of the cells, already taken for quality and safety reasons, are taken and the cells surface is analysed using a computer algorithm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-Score and computer algorithm | Experimental | Other: Z-Score and computer algorithm |
| Z-Score | Active comparator | Other: Z-Score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Woman with age 18 years or older
- Man with age 18 years or older
- Couples who could gain fertilized cells after In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI) after hormonal stimulation due to sterility treatments
- Couples presenting negative blood samples of human immunodeficiency virus (HIV) and Hepatitis B/C
- Signed routine contracts between hospital and patient wanting assisted reproductive technology (ART)
Key exclusion criteria (11 listed)
- Poor health status acc. to Investigator's judgement
- Expectation of life below 18 years
- Risk of ovarian hyperstimulation syndrome
- Avital cells (cells that do not further develop or die)
- Treatment due to fertility preservation, e.g. in case of cancer
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 |
|---|---|---|
| Z-Score and computer algorithmIn addition to the routine Z-score for zygote selection, if needed, the photographs of the zygotes already taken for quality and safety reasons are analysed using the new computer algorithm. Within a few minutes it generates a score, determining the quality of the cells. The two best cells upon Z-score result and new computer algorithm result are selected for first transfer. | Other | Z-Score and computer algorithm |
| Z-ScoreAfter fertilisation pronuclei and nucleoli can be seen inside the cells by microscope. Routinely, the alignment of nucleoli can be used generating a score, the Z-score 1-4, established by Scott. Two zygotes getting the best Z-score are selected for cell culture and the cells that develop to embryo stage are used for first transfer. | Other | Z-Score |
Primary outcome
Clinical pregnancy
Time frame: min. 4 weeks after embryo transfer
Clinical pregnancy is defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
2 secondary outcomes
Ongoing clinical pregnancy
Time frame: min. 9 weeks after embryo transfer
Life Birth
Time frame: through study completion, an average of 40 weeks after last menstrual period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 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.
Jürgen Weiss, Professor study chair
Luzerner Kantonsspital, Neue Frauenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-Score and computer algorithm and Z-Score in people with Infertility, run by Jürgen Weiss at 1 site in Switzerland.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Mar 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Weiss, Professor (+41 41 205 36 06, juergen.weiss@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy (time frame: min. 4 weeks after embryo transfer). 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 22 Mar 2017.