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Trial record 1 of 1 for:    NCT03659786
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Single-center Prospective Cumulus Cell Test Study (CC-Test)

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ClinicalTrials.gov Identifier: NCT03659786
Recruitment Status : Unknown
Verified August 2018 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Active, not recruiting
First Posted : September 6, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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

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

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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 Messenger Ribonucleic Acid (mRNA) Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study
Actual Study Start Date : October 2013
Actual Primary Completion Date : January 1, 2017
Estimated Study Completion Date : November 2018

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/embryo based on the expression pattern observed in the cumulus cells

No Intervention: Day 3 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: Day 5 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 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 [ 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.



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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 Highly Purified human Menopausal Gonadotropin (HP-hMG)
  • 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 e.g.: 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

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): NCT03659786


Locations
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Belgium
Universitair Ziekenhuis Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Study Director: Johan Smitz, Prof. Dr. Universitair Ziekenhuis Brussel
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03659786    
Other Study ID Numbers: BUN143201318000
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 10, 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