Single-center Prospective Cumulus Cell Test Study in rFSH Patients

Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients

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

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: CC-Test

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inge Van Vaerenbergh, PhD; Phone Number: +32 2 477 46 45; Email: inge.vanvaerenbergh@uzbrussel.be
• Study Contact Backup: Name: Tom Adriaenssens, MSc; Phone Number: +32 2 477 46 45; Email: tom.adriaenssens@uzbrussel.be

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Inge Van Vaerenbergh, PhD; Phone Number: +32 2 477 46 45; Email: inge.vanvaerenbergh@uzbrussel.be
      • Contact: Johan Smitz, Prof. Dr.; Phone Number: +32 2 477 50 52; Email: johan.smitz@uzbrussel.be
      • Principal Investigator: Inge Van Vaerenbergh, PhD
      • Principal Investigator: Tom Adriaenssens, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12-17 days after embryo transfer
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.	at least 9 months after embryo transfer
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	2 years after embryo transfer

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Director: Johan Smitz, Prof. Dr., Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: BUN143201318000 b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No