Single-center Prospective Cumulus Cell Test Study in rFSH Patients

NCT03663868 | Unknown

• 1 other identifier: BUN143201318000 b
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

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 by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)

  2 years after embryo transfer

Study Arms (3)

CC-Test diagnosis and Day 3 transfer

EXPERIMENTAL

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

Day 3 transfer control group

NO INTERVENTION

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)

Day 5 transfer control group

NO INTERVENTION

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)

Interventions

CC-Test DIAGNOSTIC_TEST

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

CC-Test diagnosis and Day 3 transfer

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (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 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)

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 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Johan Smitz, Prof. Dr.

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Central Study Contacts

Inge Van Vaerenbergh, PhD

CONTACT

+32 2 477 46 45; inge.vanvaerenbergh@uzbrussel.be

Tom Adriaenssens, MSc

CONTACT

+32 2 477 46 45; tom.adriaenssens@uzbrussel.be

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 10, 2018
• Study Start: August 14, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2021
• Last Updated: September 18, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)