Multicenter Prospective Cumulus Cell Test Study

NCT02962466 | Unknown

• 1 other identifier: BUN:143201628797
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

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 transfer

• Live Birth by questionaire

  et least 9 months after embryo transfer

• Cumulative Pregnancy

  2 years after pick up

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

D3 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).

D5 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-Test OTHER

classification of the oocyte based on the 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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (2)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

ULB Erasme

Anderlecht, 1070, Belgium

RECRUITING

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: 33608027 DERIVED

Study Officials

• Tom Adriaenssens, Msc

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Johan Smitz, Prof. Dr.

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Central Study Contacts

Tom Adriaenssens, Msc.

CONTACT

+ 32 2 477 50 50; Tom.Adriaenssens@UZBrussel.be

Johan Smitz, Prof. Dr.

CONTACT

+ 32 2 477 50 50; Johan.Smitz@UZBrussel.be

Study Design

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

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)