Back to resultsSingle-center Prospective Cumulus Cell Test Study in rFSH Patients
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CC-Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Universitair Ziekenhuis BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
CC-Test diagnosis and Day 3 transfer
Day 3 transfer control group
Day 5 transfer control group
Arm Description
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)
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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
Full Information
NCT ID
NCT03663868
First Posted
September 3, 2018
Last Updated
September 14, 2018
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03663868
Brief Title
Single-center Prospective Cumulus Cell Test Study in rFSH Patients
Official Title
Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CC-Test diagnosis and Day 3 transfer
Arm Type
Experimental
Arm Description
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)
Arm Title
Day 3 transfer control group
Arm Type
No Intervention
Arm Description
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)
Arm Title
Day 5 transfer control group
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
CC-Test
Intervention Description
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
Primary Outcome Measure Information:
Title
Clinical pregnancy as observed by ultrasound
Description
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
Time Frame
2 months after embryo transfer
Secondary Outcome Measure Information:
Title
Positive beta-hCG pregnancy as observed by serum analysis
Description
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
Time Frame
12-17 days after embryo transfer
Title
Live birth by questionnaire
Description
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.
Time Frame
at least 9 months after embryo transfer
Title
Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)
Description
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
Time Frame
2 years after embryo transfer
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inge Van Vaerenbergh, PhD
Phone
+32 2 477 46 45
Email
inge.vanvaerenbergh@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Adriaenssens, MSc
Phone
+32 2 477 46 45
Email
tom.adriaenssens@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Smitz, Prof. Dr.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge Van Vaerenbergh, PhD
Phone
+32 2 477 46 45
Email
inge.vanvaerenbergh@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Johan Smitz, Prof. Dr.
Phone
+32 2 477 50 52
Email
johan.smitz@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Inge Van Vaerenbergh, PhD
First Name & Middle Initial & Last Name & Degree
Tom Adriaenssens, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single-center Prospective Cumulus Cell Test Study in rFSH Patients
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