NCT03659786

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

September 3, 2018

Last Update Submit

September 6, 2018

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

    2 months after embryo transfer

Secondary Outcomes (3)

  • Positive beta-hCG Pregnancy as observed by serum analysis

    12-17 days after embryo transfer

  • Live birth by questionnaire

    at least 9 months after embryo transfer

  • Cumulative pregnancy

    2 years after embryo transfer

Study Arms (3)

CC-Test diagnosis and Day 3 transfer

EXPERIMENTAL

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

Day 3 transfer control group

NO INTERVENTION

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)

Day 5 transfer control group

NO INTERVENTION

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)

Interventions

CC-TestOTHER

Classification of the oocyte/embryo based on the expression pattern observed in the cumulus cells

CC-Test diagnosis and Day 3 transfer

Eligibility Criteria

AgeUp to 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

  • Van Vaerenbergh I, Adriaenssens T, Coucke W, Van Landuyt L, Verheyen G, De Brucker M, Camus M, Platteau P, De Vos M, Van Hecke E, Rosenthal A, Smitz J. Improved clinical outcomes after non-invasive oocyte selection and Day 3 eSET in ICSI patients. Reprod Biol Endocrinol. 2021 Feb 19;19(1):26. doi: 10.1186/s12958-021-00704-5.

    PMID: 33608027DERIVED

Study Officials

  • Johan Smitz, Prof. Dr.

    Universitair Ziekenhuis Brussel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 6, 2018

Study Start

October 1, 2013

Primary Completion

January 1, 2017

Study Completion

November 1, 2018

Last Updated

September 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)