InfertilityNCT03663868
Single-center Prospective Cumulus Cell Test Study in rFSH Patients
A study testing CC-Test in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- CC-Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Aug 2018to Aug 2021
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- scheduled for intracytoplasmatic sperm injection (ICSI) and single (or double) embryo transfer on day 3
- patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with recombinant Follicle Stimulating Hormone (FSH)
- undergoing first or second IVF or ICSI cycle with transfer
- Body Mass Index (BMI) between 17 and 33
- regular menstrual cycle (between 24 and 35 days)
Who cannot join
- smokers (> 10 cigarettes per day)
- patients requesting Pre-implantation Genetic Diagnosis (PGD)
- patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
- couples where the partner has an extremely low sperm count i.e.: extreme oligo-astheno-teratozoospermia (OAT) (< 100.000/ml) or scheduled for testicular sperm extraction (TESE)
- results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Inge Van Vaerenbergh, PhD, +32 2 477 46 45, inge.vanvaerenbergh@uzbrussel.be
Johan Smitz, Prof. Dr., +32 2 477 50 52, johan.smitz@uzbrussel.be
About this study
Official title: Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients
Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients
- Conditions
- Infertility
- Being tested
- CC-Test
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-TestDiagnostic test
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
| Study group | Role | What they receive |
|---|---|---|
| CC-Test diagnosis and Day 3 transfer | Experimental | Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos + the extra cumulus cell based diagnosis and transfer of the best embryo based on morphology and CC diagnosis on day 3 of embryo growth (cleavage stage embryo) Receives: Diagnostic Test: CC-Test |
| Day 3 transfer control group | No intervention | Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 3 of embryo growth (cleavage stage embryo) |
| Day 5 transfer control group | No intervention | Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 5 of embryo growth (blastocyst stage embryo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy as observed by ultrasound
This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database
Measured: 2 months after embryo transfer
Secondary outcomes (3)
Positive beta-hCG pregnancy as observed by serum analysis
This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database
Measured: 12-17 days after embryo transfer
Live birth by questionnaire
This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database. This measurement does not include a scale, there is either a child born or not. The date of delivery and the gender of the child are asked together with eventual complications.
Measured: at least 9 months after embryo transfer
Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)
This is the compilation of the data gathered in outcome 1 and 3 for eventual consecutive cycles. This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database
Measured: 2 years 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 posted10 Sep 2018
- Study start14 Aug 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2021 (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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Smitz, Prof. Dr., Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663868
- Sponsor's protocol ID
- BUN143201318000 b
- Status last verified
- Aug 2018
- First submitted
- 3 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients
- ClinicalTrials.gov ID
- NCT03663868
- Acronym / sponsor ID
- BUN143201318000 b
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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.
Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CC-Test diagnosis and Day 3 transfer | Experimental | Diagnostic Test: CC-TestPatients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos + the extra cumulus cell based diagnosis and transfer of the best embryo based on morphology and CC diagnosis on day 3 of embryo growth (cleavage stage embryo) |
| Day 3 transfer control group | No intervention | –Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 3 of embryo growth (cleavage stage embryo) |
| Day 5 transfer control group | No intervention | –Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 5 of embryo growth (blastocyst stage embryo) |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- scheduled for intracytoplasmatic sperm injection (ICSI) and single (or double) embryo transfer on day 3
- patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with recombinant Follicle Stimulating Hormone (FSH)
- undergoing first or second IVF or ICSI cycle with transfer
- Body Mass Index (BMI) between 17 and 33
- regular menstrual cycle (between 24 and 35 days)
Key exclusion criteria (5 listed)
- smokers (> 10 cigarettes per day)
- patients requesting Pre-implantation Genetic Diagnosis (PGD)
- patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
- couples where the partner has an extremely low sperm count i.e.: extreme oligo-astheno-teratozoospermia (OAT) (< 100.000/ml) or scheduled for testicular sperm extraction (TESE)
- results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect
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 |
|---|---|---|
| CC-TestClassification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells | Diagnostic test | CC-Test diagnosis and Day 3 transfer |
Primary outcome
Clinical pregnancy as observed by ultrasound
Time frame: 2 months after embryo transfer
This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database
3 secondary outcomes
Positive beta-hCG pregnancy as observed by serum analysis
Time frame: 12-17 days after embryo transfer
Live birth by questionnaire
Time frame: at least 9 months after embryo transfer
Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)
Time frame: 2 years after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Johan Smitz, Prof. Dr. study director
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC-Test in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 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: status not confirmed, as of the sponsor's last update on 18 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 Belgium. 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 Inge Van Vaerenbergh, PhD (+32 2 477 46 45, inge.vanvaerenbergh@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy as observed by ultrasound (time frame: 2 months 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 18 Sep 2018.