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Trial record 5 of 838 for:    observed | Belgium

Multicenter Prospective Cumulus Cell Test Study (MC_CC-Test)

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ClinicalTrials.gov Identifier: NCT02962466
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
Performing an additional non invasive oocyte diagnostic test based on cumulus gene expression could improve the outcome of the ART cycle.

Condition or disease Intervention/treatment Phase
Pregnancy Other: CC-Test Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cumulus Cell Messenger Ribonucleic Acid (mRNA) Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Multicenter Study
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: CC-Test diagnosis and Day 3 transfer
Patients undergo the standard ART treatment, as prescribed 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).
Other: CC-Test
classification of the oocyte based on the expression pattern observed in the cumulus cells

No Intervention: D3 transfer control group
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on day 3 of embryo growth (cleavage stage embryo).
No Intervention: D5 transfer control group
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on day 5 of embryo growth (blastocyst stage embryo).



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 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 questionaire [ Time Frame: et 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

  3. Cumulative Pregnancy [ Time Frame: 2 years after pick up ]
    this is the compilation of the data gathered in endpoint 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.



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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 embryo transfer on day 3
  • patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with Highly Purified human Menopausal Gonadotropin (HP-hMG)
  • no more than 2 previous IVF or ICSI cycles with transfer prior to this one.
  • Body mass index (BMI) should be higher than 17 and lower than 32
  • patients should have regular menstrual cycles (between 24 and 35 days).

Exclusion Criteria:

  • are smokers (>10 cigarettes per day)
  • patients requesting Prenatal Genetic Diagnosis
  • patients having polycystic ovary syndrome (PCOS), or Severe Endometriosis (AFS Stage 3-4)
  • couples where the partner has an extremely low sperm count e.g.: extreme oligo-astheno-teratozoospermia (OAT), (<100.000/ml) or 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.

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): NCT02962466


Contacts
Contact: Tom Adriaenssens, Msc. + 32 2 477 50 50 Tom.Adriaenssens@UZBrussel.be
Contact: Johan Smitz, Prof. Dr. + 32 2 477 50 50 Johan.Smitz@UZBrussel.be

Locations
Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Brussel, Belgium, 1090
Contact: Tom Adriaenssens, Msc.    + 32 2 477 50 50    Tom.Adriaenssens@UZBrussel.be   
Contact: Johan Smitz, Prof. Dr.    + 32 2 477 50 50    Johan.Smitz@UZBrussel.be   
ULB Erasme Recruiting
Anderlecht, Belgium, 1070
Contact: Fabienne Devreker, Prof. Dr.    + 32 2 555 45 77      
Contact: Noe Moutard, Dr.    + 32 2 555 51 51    Noe.Moutard@erasme.ULB.ac.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Tom Adriaenssens, Msc Universitair Ziekenhuis Brussel
Study Director: Johan Smitz, Prof. Dr. Universitair Ziekenhuis Brussel

Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02962466     History of Changes
Other Study ID Numbers: BUN:143201628797
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No