Single-center Prospective Cumulus Cell Test Study in rFSH Patients

Not Applicable

• Conditions: Infertility
• Interventions: Diagnostic Test: CC-Test

• Registration Number: NCT03663868
• Lead Sponsor: 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 for rFSH stimulated patients

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-08-14
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC-Test diagnosis and Day 3 transfer	CC-Test	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)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy as observed by ultrasound	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

Name	Time	Method
Positive beta-hCG pregnancy as observed by serum analysis	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
Live birth by questionnaire	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.
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	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

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussels, Belgium