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Single-center Prospective Cumulus Cell Test Study in rFSH Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663868
Recruitment Status : Unknown
Verified August 2018 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : September 10, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Study Description
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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

Condition or disease Intervention/treatment Phase
Infertility Diagnostic Test: CC-Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: CC-Test diagnosis and Day 3 transfer
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)
 Diagnostic Test: CC-Test
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
No Intervention: Day 3 transfer control group
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)
No Intervention: Day 5 transfer control group
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Positive beta-hCG pregnancy as observed by serum analysis [ Time Frame: 12-17 days 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

  2. Live birth by questionnaire [ Time Frame: at least 9 months after embryo transfer ]
    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.

  3. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663868


Contacts
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Contact: Inge Van Vaerenbergh, PhD +32 2 477 46 45 inge.vanvaerenbergh@uzbrussel.be
Contact: Tom Adriaenssens, MSc +32 2 477 46 45 tom.adriaenssens@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Inge Van Vaerenbergh, PhD    +32 2 477 46 45    inge.vanvaerenbergh@uzbrussel.be   
Contact: Johan Smitz, Prof. Dr.    +32 2 477 50 52    johan.smitz@uzbrussel.be   
Principal Investigator: Inge Van Vaerenbergh, PhD         
Principal Investigator: Tom Adriaenssens, MSc         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Study Director: Johan Smitz, Prof. Dr. Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03663868    
Other Study ID Numbers: BUN143201318000 b
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility