Single-center Prospective Cumulus Cell Test Study

Pregnancy Clinical Trial

— CC-Test  

Official title:

Cumulus Cell Messenger Ribonucleic Acid (mRNA) Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03659786
• Other study ID #: BUN143201318000
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: November 2018

Study information

• Verified date: August 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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 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)

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 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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• CC-Test
Classification of the oocyte/embryo based on the expression pattern observed in the cumulus cells

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cumulative pregnancy	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